Context: Atrial fibrillation (AF) is an increasingly prevalent heart rhythm condition in adults. It is considered a common cardiovascular condition with complex clinical management. The increasing prevalence and complexity in management underpin the need to adapt and innovate in the delivery of care for people living with AF. There is a need to systematically examine the optimal way in which clinical services are organised to deliver evidence-based care for people with AF. Recommended approaches include collaborative, organised multidisciplinary, and virtual (or eHealth/mHealth) models of care.

To assess the effects of clinical service organisation for AF versus usual care for people with all types of AF.

We included randomised controlled trials (RCTs), published as full texts and as abstract only, involving adults (≥ 18 years) with a diagnosis of any type of AF. We included RCTs comparing organised clinical service, disease-specific management interventions (including e-health models of care) for people with AF that were multicomponent and multidisciplinary in nature to usual care.

Nurse-led care vs. usual care for patients with atrial fibrillation: results of a randomized trial of integrated chronic care vs. routine clinical care in ambulatory patients with atrial fibrillation.

Abstract:
The management of patients with atrial fibrillation (AF) is often inadequate due to deficient adherence to the guidelines. A nurse-led AF clinic providing integrated chronic care to improve guideline adherence and activate patients in their role, may effectively reduce morbidity and mortality but such care has not been tested in a large randomized trial. Therefore, we performed a randomized clinical trial to compare the AF clinic with routine clinical care in patients with AF.

We randomly assigned 712 patients with AF to nurse-led care and usual care. Nurse-led care consisted of guidelines based, software supported integrated chronic care supervised by a cardiologist. The primary endpoint was a composite of cardiovascular hospitalization and cardiovascular death. Duration of follow-up was at least 12 months. Adherence to guideline recommendations was significantly better in the nurse-led care group. After a mean of 22 months, the primary endpoint occurred in 14.3% of 356 patients of the nurse-led care group compared with 20.8% of 356 patients receiving usual care [hazard ratio: 0.65; 95% confidence interval (CI) 0.45-0.93; P= 0.017]. Cardiovascular death occurred in 1.1% in the nurse-led care vs. 3.9% in the usual care group (hazard ratio: 0.28; 95% CI: 0.09-0.85; P= 0.025). Cardiovascular hospitalization amounted (13.5 vs. 19.1%, respectively, hazard ratio: 0.66; 95% CI: 0.46-0.96, P= 0.029).

Nurse-led care of patients with AF is superior to usual care provided by a cardiologist in terms of cardiovascular hospitalizations and cardiovascular mortality. Trial registration information: Clinicaltrials.gov identifier number: NCT00391872.

Cost-effectiveness of a specialized atrial fibrillation clinic vs. usual care in patients with atrial fibrillation.

Abstract:
A recent randomized controlled trial demonstrated significant reductions in cardiovascular hospitalizations and deaths with a nurse-led integrated chronic care approach in patients with atrial fibrillation (AF) compared with usual care. The aim of the present study is to assess cost-effectiveness of this nurse-led care programme vs. usual care.

A cost-effectiveness analysis was undertaken alongside the randomized controlled trial in which 712 patients were included at the Maastricht University Medical Centre, The Netherlands, and allocated to nurse-led care or usual care. Nurse-led care implied guideline-adherent management, steered by dedicated software, supervised by cardiologists. Usual care was regular outpatient care performed by cardiologists. A cost per life-year and a cost per quality-adjusted life-year (QALY) analysis was performed, both from a hospital perspective. The nurse-led care programme was associated with slightly more life-years and QALYs at a lower cost. Specifically, the nurse-led programme contributed to 0.009 QALY gains with a reduced cost of €1109 per patient and a gain of 0.02 life-years with a reduced cost of €735 per patient. Therefore, the nurse-led programme would be considered dominant. In fact, for all the possible values of willingness to pay for a QALY the nurse-led programme is considered to be more likely cost-effective than the care as usual.

The cost-effectiveness analysis in the present study demonstrated that a nurse-led integrated care approach will save costs and improve survival and quality of life, and is therefore a cost-effective management strategy for patients with AF.

A prospective controlled trial comparing weekly self-testing and self-dosing with the standard management of patients on stable oral anticoagulation.

Abstract: Oral anticoagulant therapy requires frequent laboratory controls of its intensity to assure therapeutic efficacy and to prevent potentially life threatening adverse events. It is generally assumed, that increasing the frequency of testing would lead to a better control of anticoagulation. We tested this hypothesis in a prospective controlled trial comparing weekly self-testing and self-dosing (self management) with the standard-management of these patients in an anticoagulation clinic. Only patients with stable anticoagulation were included into the study. We recorded 2733 weekly determinations of the intensity of anticoagulation (INR) in 49 patients on self-testing and self-dosing and 539 determinations of the INR in 53 patients on standard-management. Two intensities of anticoagulation were used in each group: a target INR of 3.5 for patients with artificial heart valves (target range: 2.5-4.5) and a target INR 2.5 (target range: 2.0-3.0) for patients with atrial fibrillation or venous thromboembolism. The deviation from the target INR, the fraction of INR determinations within the preset therapeutic range and the difference between the target INR and the actually achieved mean INR were the three major endpoints of the study. The mean deviation from the target INR was smaller in the groups of patients on self-management compared to the patients on standard-management. Individual deviations were significantly (p <0.0001) dependent on the type of management in interaction with the treatment intensity in a general linear model. Patients on weekly self-testing and self-dosing had more INR values within the therapeutic range than patients on standard-management (86.2% vs. 80.1% at INR range 2.5-4.5; 82.2 vs. 68.9 at INR range 2.0-3.0). The achieved mean INR was almost identical with the target INR in the patients on self-management but was significantly (p <0.005) below the target INR in the high intensity anticoagulation group on standard-management (target INR:3.5; achieved mean INR: 3.19; CI 0.95: 3.05-3.34). Our data show, that weekly self-testing and self-dosing leads to a better control of anticoagulation than standard treatment in an anticoagulation clinic.

Effect of computer-aided management on the quality of treatment in anticoagulated patients: a prospective, randomized, multicenter trial of APROAT (Automated PRogram for Oral Anticoagulant Treatment).

Abstract:
We carried out a prospective, randomized trial to test whether a computer-based decision support system to initiate and maintain oral anticoagulant (OA) treatment can improve the laboratory quality of therapy.

Two separate sets of patients on oral anticoagulants, in five Italian anticoagulant clinics, were studied: 335 patients in the first three months of treatment (stabilization phase), 916 patients (775 patient-years) beyond the third month of treatment (maintenance phase). Patients were randomized to a computerized system, which included algorithms able to suggest OA dosing and to schedule appointments (computer-aided dosing) or to an arm in which OA were prescribed by the same teams of expert physicians without such algorithms (control group). Primary outcomes were: A) the percentage of patients reaching a stable state of anticoagulation during each of the first three months of treatment; B) the percentage of time individuals spent within the aimed therapeutic range (maintenance phase).

Patients in the computer-aided dosing group achieved a stable state significantly faster (p<0.01) and they spent more time within the therapeutic range during maintenance (p<0.001) than controls. The favorable effect of computer-aided dosing was mainly due to a reduction of the time spent below the therapeutic range and was associated with an increase of mean INR value, of anticoagulant drug dosage, and with a reduction of the number of appointments per patient (all changes significant: p<0.001).

The computer decision-aided support improves the laboratory quality of anticoagulant treatment, both during long-term maintenance and in the early, highly unstable phase of treatment, and it also significantly reduces the number of scheduled laboratory controls.

Improving the quality of anticoagulation of patients with atrial fibrillation in managed care organizations: results of the managing anticoagulation services trial.

Abstract: Randomized trials have indicated that well-managed anticoagulation with warfarin could prevent more than half of the strokes related to atrial fibrillation. However, many patients with atrial fibrillation who are eligible for this therapy either do not receive it or are not maintained within an optimal prothrombin time-international normalized ratio (INR) range. We sought to determine whether an anticoagulation service within a managed care organization would be a feasible alternative for providing anticoagulation care. We performed a multi-site randomized trial in six large managed care organizations in the United States. Subjects were aged 65 years or older and had nonvalvular atrial fibrillation. At each site, physician practices were divided into two geographically defined practice clusters; each site was randomly assigned to have one intervention and one control cluster. The intervention cluster received an anticoagulation service that satisfied specifications for high-quality anticoagulation care and was coordinated through the managed care organization. Control clusters continued with their usual provider-based care. We measured the proportion of time that warfarin-treated patients in each of the clusters (intervention and control) were in the target range for the INR at baseline, and again during a follow-up period. Five of the six selected sites succeeded at developing an anticoagulation service. Patients in the intervention and control clusters had similar demographic characteristics, contraindications to warfarin, and risk factors for stroke. Among patients (n = 144 in the intervention clusters; n = 118 in the control clusters) for whom data were available during the baseline and follow-up periods, the changes in percentages of time in the target range were similar for those in the intervention clusters (baseline: 47.7%; follow-up: 55.6%) and in the control clusters (baseline: 49.1%; follow-up: 52.3%; intervention effect: 5%; 95% confidence interval: -5% to 14%; P = 0.32). Although it was feasible in a managed care organization to implement anticoagulation services that were tailored to local circumstances, provision of this service did not improve anticoagulation care compared with usual care. The effect of the anticoagulation service was limited by the utilization of the service, the degree to which the referring physician supports strict adherence to recommended target ranges for the INR, and the ability of the anticoagulation service to identify and to respond to out-of-range values promptly.

Do anticoagulation management services improve care? Implications of the Managing Anticoagulation Services Trial.

Abstract: An Anticoagulation Clinic Service (ACS) has been proposed as one strategy for improving warfarin treatment for patients with atrial fibrillation. In the Managing Anticoagulation Services Trial (MAST), ACSs meeting specifications for high quality care were established in six managed care organizations (MCOs) which had the patients and resources to support this initiative. The trial followed 1165 patients age >or=65 years who had atrial fibrillation as the primary reason for anticoagulation and were enrolled in a participating MCO. The 593 patients in the intervention group saw physicians in a practice cluster which had randomly been assigned to have access to an ACS. These physicians used the ACS on average for about 48% of eligible patients. The 572 patients in the control group received care from physicians in a practice cluster which could not refer patients to the ACS established for the trial but was otherwise unrestricted. The two clusters were compared on the proportion of time warfarin-treated patients were in the target range (2-3) prothrombin time-international normalized ratio (INR) during a 9-month baseline and a 9-month follow-up period. Among patients ( n = 264) for whom data were available for both periods, the changes in percentages of time in the target range were similar in the intervention cluster (baseline: 47.7%; follow-up 55.6%) and in the control cluster (baseline: 49.1%; follow-up: 52.3%; intervention effect: 5%; 95% confidence interval: -5% to 14%; P = 0.32). In both practice clusters, patients had subtherapeutic INR values (1.5 to 1.99) about one fourth of the time. Providing an ACS in a managed care setting did not appear to improve anticoagulation care over the usual care provided at the sites in this trial but could be a reasonable consideration in a practice setting where time in target range is less than 50%. A higher rate of utilization and a more aggressive stance toward subtherapeutic INR values could potentially enhance the effectiveness of an ACS.

The value of education and self-monitoring in the management of warfarin therapy in older patients with unstable control of anticoagulation.

Abstract: Of 125 patients aged 65 years or over, with atrial fibrillation taking warfarin for at least 12 months, with a standard deviation (SD) of prothrombin time, expressed as the International Normalized Ratio (INR) >0.5 over the previous 6 months, 40 were randomized to continue with usual clinic care and 85 to receive education about warfarin. Of these, 44 were randomized to self-monitor their INR and 41 returned to clinic. Compared with the previous 6 months there was a significant increase in percentage time within the therapeutic range for the 6 months following education [61.1 vs. 70.4; mean difference 8.8; 95% confidence interval (CI): -0.2-17.8; P = 0.054] and following education and self-monitoring (57 vs. 71.1; mean difference 14.1; 95% CI: 6.7-21.5; P < 0.001), compared with those patients following usual clinic care (60.0 vs. 63.2; mean difference 3.2; 95% CI: -7.3-13.7). Using the same comparative periods, the INR SD fell by 0.24 (P < 0.0001) in the group allocated to education and self-monitoring, 0.26 (P < 0.0001) in the group receiving education alone and 0.16 (P = 0.003) in the control group. Inter-group differences were not statistically significant (intervention groups 0.26 +/- 0.30 vs. control 0.16 +/- 0.3, P = 0.10). Quality-of-life measurements and health beliefs about warfarin were unchanged (apart from emotional role limitation) with education or education and self-monitoring. Patient education regarding anticoagulation therapy could be a cost-effective initiative and is worthy of further study.

Self-management of oral anticoagulation in nonvalvular atrial fibrillation (SMAAF study).

Abstract:
Most patients with atrial fibrillation are at risk of suffering thromboembolic events. This risk can be reduced by twothirds by efficient anticoagulation. This prospective multi-center trial investigated whether the quality of treatment can be improved by self-management in patients with atrial fibrillations (SMAAF Study) compared to conventional patient management by the family doctor.

Two thousand patients suitable for self-management were to be randomized into the two arms of the study. In the period of investigation from December 1999 to July 2001, only 202 patients (64.3+/-9.2 years, 69.3% men) consented to participate. The study was discontinued prematurely since the number of patients was too low. As a consequence, the group comparison is confined to the evaluation of the INR values measured using the two-tailed t test.

Of the 202 patients included, 101 were assigned to the self-management group (64.6+/-9.6 years, 71.4% men) and 101 (64.1+/-8.9 years, 61.4% men, n.s.) were assigned to the group managed by the family doctor. The total number of INR measurements was 2 865. This comprised 2 072 measurements in patients under self-management and 793 in the family doctor group. The values were within the target range significantly more frequently (p=0.0061) in patients under self-management (67.8%) as compared to the family doctor group (58.5%). There was a trend with regard to the time within target range, but the difference was not significant (178.8+/-126 days as compared to 155.9+/-118.4 days). In the self-management group, there were two severe hemorrhages, and there was one thromboembolic event in the family doctor group.

Management of oral anticoagulation by INR self-management in patients with atrial fibrillation is not inferior to conventional care.

Perceived effects on patients' health of participation in the atrial fibrillation follow-up investigation of rhythm management study.

Abstract:
Patients' views about participation in clinical trials have been explored using end-of-study questionnaires for various disease entities. However, little is known about why individuals with atrial fibrillation (AF) choose to participate in clinical trials or how they view their research experience. Understanding these perceptions should provide valuable information for future studies in developing methods to enhance enrollment, optimize adherence to therapies, and maximize patient retention.

The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Study was a randomized trial of rate-control versus rhythm-control for the management of AF. This descriptive ancillary study used a 7-item questionnaire comprising closed and open-ended items that explored: (1) perceptions of benefits from participation, (2) motivation for enrolling, and (3) satisfaction with research staff and operations.

A total of 741/1,032 participants (72%) at 34 of 213 participating AFFIRM sites responded, representing 18% of the 4,060 patients enrolled. The mean follow-up of these respondents was 3.8 +/- 1.1 years. Most respondents (91%) felt that they received enough information about AFFIRM before enrolling and that the results would benefit themselves (88%) and others (91%). Most respondents felt study participation improved awareness about AF (90%) and facilitated coordination of their healthcare (89%). Virtually all were satisfied with information received from AFFIRM personnel (96%), and most (98%) reported that they had received "good care." Responses were similar between randomization groups (rate-control or rhythm-control) and between those younger than 65 years and those 65 years or older. Participants in sinus rhythm at last follow-up were more likely to believe that their medical care in AFFIRM was better than what they would otherwise have received, and were more likely to perceive their treatment course as entailing fewer emergency room visits, hospitalizations, and doctor visits. Regularly scheduled appointments and ongoing availability of staff to answer questions appeared to increase participants' confidence and reduce anxiety.

Patients enrolled in a long-term clinical trial for management of AF were overwhelmingly satisfied with participation.


Context: Sickle cell disease (SCD) refers to a group of genetic disorders characterized by the presence of an abnormal haemoglobin molecule called haemoglobin S (HbS). When subjected to oxidative stress from low oxygen concentrations, HbS molecules form rigid polymers, giving the red cell the typical sickle shape. Antioxidants have been shown to reduce oxidative stress and improve outcomes in other diseases associated with oxidative stress. Therefore, it is important to review and synthesize the available evidence on the effect of antioxidants on the clinical outcomes of people with SCD.

To assess the effectiveness and safety of antioxidant supplementation for improving health outcomes in people with SCD.

We included randomized and quasi-randomized controlled trials comparing antioxidant supplementation to placebo, other antioxidants, or different doses of antioxidants, in people with SCD.

Reduction of pain episodes and prothrombotic activity in sickle cell disease by dietary n-3 fatty acids.

Abstract: The effects of dietary n-3 fatty acids (n-3FAs) on the frequency of pain episodes and ex vivo blood tests of thrombosis have been evaluated in patients with sickle cell disease (SCD) utilizing a double-blind, olive oil-controlled clinical trial. Dietary n-3FA therapy (0.1 g/kg/d) was provided as menhaden fish oil (0.25 g/kg/d) containing 12% eicosapentaenoic acid (EPA), and 18% docosahexaenoic acid (DHA). Within 1 month dietary n-3FAs exchanged with n-6FAs in plasma and erythrocyte membrane phospholipids (p <0.01 in all cases). Treatment with dietary n-3FAs for 1 year reduced the frequency of pain episodes requiring presentation to the hospital from 7.8 events during the preceding year to 3.8 events/year (p <0.01; n = 5). By contrast, subjects receiving control dietary olive oil (n = 5) experienced 7.1 pain events/year, compared to 7.6 during the previous year (p >0.4). The reduction in episodes in n-3FA-treated subjects was also significant when compared to control subjects (p <0.01). Dietary n-3FA therapy was not associated with hemorrhagic, gastrointestinal or other adverse effects. Compared to 10 asymptomatic African-American controls, sickle cell subjects demonstrated significantly increased pretreatment: 1) flow cytometric expression of platelet membrane P-selectin (CD62p; p <0.01) and annexin V binding sites (p = 0.02); 2) plasma levels of platelet-specific secretory proteins platelet factor 4 (PF4) and beta-thromboglobulin (betaTG) (p <0.01 in both cases); 3) plasma products of thrombin generation, prothrombin fragment 1.2 (F1.2) and thrombin:antithrombin (TAT) complex (p <0.01 in both cases); and 4) plasma levels of thrombolytic products, D-dimer and plasmin:antiplasmin (PAP) complex (p <0.01 in both cases). Treatment with dietary n-3FAs concurrently decreased plasma levels of F1.2, D-dimer, and PAP (p <0.05, compared to olive oil controls), implying that the reduction in pain events was related to n-3FA-dependent inhibition of thrombosis. We conclude that dietary n-3FAs reduce the frequency of pain episodes perhaps by reducing prothrombotic activity in sickle cell disease.

Effect of zinc supplementation on growth and body composition in children with sickle cell disease.

Abstract:
Poor growth and delayed maturation in children with sickle cell disease (SCD) may be due, in part, to mild zinc deficiency.

The objective was to determine the effects of zinc supplementation on growth and body composition in children with SCD.

Forty-two prepubertal children (20 girls and 22 boys) aged 4-10 y with SCD-SS were randomly assigned to receive 10 mg elemental Zn/d in cherry syrup (zinc group) or cherry syrup alone (control group). The 2 groups were stratified by sex and initial height status. Dietary intakes were evaluated and anthropometric, high-precision knee-height, and plasma zinc measurements were made at baseline and at 3, 6, and 12 mo. Body composition was determined every 6 mo with dual-energy X-ray absorptiometry, and z scores for anthropometric variables were computed from national reference data. Longitudinal-mixed-effects analysis was used to test for differences between the groups over the 12-mo observation period.

Thirty-eight children completed the study. No significant differences were observed at baseline. After 12 mo, the zinc group had significantly greater mean (+/- SE) increases in height (0.66 +/- 0.29 cm/y), sitting height (0.97 +/- 0.40 cm/y), knee height (3.8 +/- 1.2 mm/y), and arm circumference z scores (0.27 +/- 0.12 cm/y). Height-for-age and weight-for-age z scores decreased significantly by 0.11 +/- 0.04 and 0.13 +/- 0.05, respectively, in the control group but did not change significantly in the zinc group.

Prepubertal children with SCD-SS may have zinc deficiency and may benefit from zinc supplementation to improve linear growth and weight gain.

Effects of N-acetylcysteine on dense cell formation in sickle cell disease.

Abstract: The extent to which dense and irreversible sickle cells (ISCs) contribute to vaso-occlusive episodes in sickle cell disease remains unclear. N-Acetylcysteine (NAC) inhibits dense cell and ISC formation in sickle erythrocytes in vitro and restores glutathione levels toward normal. A phase II double-blind randomized clinical trial was completed to determine the efficacy of NAC in decreasing dense cell and ISC formation, and vaso-occlusive episodes in sickle cell disease. Twenty-one subjects with a history of at least two vaso-occlusive episodes per year and 6% dense cells were enrolled. Four treatment groups were analyzed; NAC at a dose of 2,400 mg per day decreased the percent dense cells from 20.1 +/- 2.9 to 12.6 +/- 2.1 (P < 0.05) and increased red cell glutathione levels from 292.8 +/- 74.5 to 576.7 +/- 155.1 (P < 0.05). In addition, we observed a decrease in vaso-occlusive episodes from 0.03 to 0.006 episodes per person-days and a decreased in relative risk to R = 0.39. Although NAC did not significantly decrease the number of ISCs, there was a downward trend at all doses tested. In summary, NAC inhibited dense cell formation, restored glutathione levels toward normal, and decreased vaso-occlusive episodes at a well-tolerated dose of 2,400 mg per day. To determine the long-term efficacy and safety of NAC, a multicenter phase III clinical trial is required.

Plasma zinc is an insensitive predictor of zinc status: use of plasma zinc in children with sickle cell disease.

Abstract:
This study was designed to explore the use of plasma zinc in determining zinc deficiency in children with sickle cell disease-SS (SCD-SS) as indicated by a growth response to zinc supplementation.

Fasting plasma zinc was assessed in children with SCD-SS (ages 4 to 10 years) who were randomly assigned to receive 10 mg zinc/d in cherry syrup (zinc) or cherry syrup alone (placebo) for 12 months. Evaluations for growth, dietary intake, and other biochemical parameters were made at baseline and 3, 6, and 12 months. Longitudinal mixed effects analysis evaluated differences between groups over 12 months.

A total of 38 prepubertal children (20 male and 18 female; 18 zinc and 20 placebo) completed the study (7.1 +/- 1.7 years old). At baseline, plasma zinc was low (< or = 70 microg/dL) in 7 male subjects. Despite the significant increase in height over 12 months (+0.7 cm) with zinc supplementation (p = .019), plasma zinc did not change over the 12 months of study, and there was no association between plasma zinc and linear growth. Those children with low plasma zinc who received zinc supplementation showed improved linear growth.

These findings suggest that plasma zinc is an insensitive indicator of zinc status in children with SCD-SS. Children with low plasma zinc will benefit from zinc supplementation. However, some children with normal plasma zinc and poor growth may also have growth-limiting zinc deficiency and exhibit a growth response to zinc supplementation. Although this study focused on children with SCD-SS, results may be generalized to other pediatric clinical illnesses where nutrition-related growth failure is investigated.

Zinc supplementation decreases oxidative stress, incidence of infection, and generation of inflammatory cytokines in sickle cell disease patients.

Abstract: Zinc deficiency is common in adult sickle-cell disease (SCD) patients. We previously demonstrated that zinc supplementation to adult SCD patients decreased the incidences of infections and hospital admissions. We hypothesize that zinc supplementation improves T-helper cell function and decreases vascular endothelial cell activation, oxidative stress, and nuclear factor-kappa B (NF-kappaB)-DNA binding in mononuclear cells (MNCs) in SCD patients. To test this hypothesis, 36 SCD patients were recruited and randomly divided into 2 groups. One group (n = 18) received 25-mg zinc orally thrice a day for 3 months. The other group (n = 18) received placebo. The results indicate that the zinc-supplemented group had decreased incidence of infections compared with the placebo group. After zinc supplementation, red blood cell, hemoglobin (Hb), hematocrit, (Hct), plasma zinc, and antioxidant power increased; plasma nitrite and nitrate (NOx), lipid peroxidation products, DNA oxidation products, and soluble vascular cell adhesion molecule-1 decreased in the zinc-supplemented group, compared with the placebo group. Zinc-supplemented patients exhibited significant decreases in lipopolysaccharide-induced tumor necrosis factor-alpha (TNF-alpha) and IL-1beta mRNAs, and TNF-induced nuclear factor of kappaB-DNA binding in MNCs, compared with the placebo group. Ex vivo addition of zinc to MNCs isolated from the placebo subjects decreased TNF-alpha and IL-1beta mRNAs. Zinc supplementation also increased relative levels of IL-2 and IL-2Ralpha mRNAs in phytohemagglutinin-p-stimulated MNCs. These results suggest that zinc supplementation may be beneficial to SCD patients.

Alpha-lipoic acid modifies oxidative stress parameters in sickle cell trait subjects and sickle cell patients.

Abstract:
Oxidative stress plays a crucial role in the sickle cell disease. Alpha-lipoic acid (ALA) is a potent antioxidant that is employed in the treatment of several diseases. The objective of this study was to test the ALA effect in the sickle cell disease (SCD) treatment.

Sixty subjects were selected and divided into groups according to the hemoglobin profile: AA (normal), AS (SCD trait subject) and SS (SCD patient). Patients were randomized into a placebo-controlled trial and treated with either ALA (200 mg) or vehicle. Blood samples were collected before supplementation and after 3 months of treatment. Catalase (CAT), superoxide dismutase (SOD), glutathione peroxidase (GPx) activities and total antioxidant status (TAS) were evaluated as measure of antioxidant defense. Lipid and protein damages were quantified by malondialdehyde (MDA) and carbonyl assays, respectively.

CAT activity significantly increased in the AS group after ALA treatment and GPx activity presented significant decrease in all groups. SOD activity was not different in any group. Data on MDA and carbonyl levels showed significant reduction in the AA group with ALA treatment. TAS decreased in the same group.

ALA treatment protected AA individuals from oxidative damage to lipids and proteins. In SCD subjects, the dose applied was not effective to prevent the oxidative damage.

A randomized phase II trial of Arginine Butyrate with standard local therapy in refractory sickle cell leg ulcers.

Abstract: Sickle cell leg ulcers are often debilitating, refractory to healing, and prone to recurrence. Healing of leg ulcers was incidentally observed during dose-ranging trials of Arginine Butyrate in beta haemoglobinopathies. Here, a controlled Phase II trial was performed in sickle cell patients who had lower extremity ulcers refractory to standard care for at least 6 months. Patients were randomized to receive standard local care alone (Control Arm) or standard care with Arginine Butyrate administered 5 d/week (Treatment Arm), for 12 weeks. Ulcers were photographed weekly, traced, and ulcer areas were calculated by computerized planimetry and compared between the two study arms. Twenty-seven study courses were evaluated. Control Arm subjects had 25 ulcers with a mean area of 25·7 cm(2) initially and 23·2 cm(2) after 12 weeks; 2/25 (8%) healed completely. Treatment Arm subjects had 37 ulcers with a mean area of 50·6 cm(2) initially and 28·3 cm(2) at 12 weeks; 11/37 of these (30%) healed completely. After 3 months, proportions of ulcers which healed were 6/25 (24%) and 29/37 (78%), in the Control and Treatment Arms respectively (P < 0·001). These findings strongly suggest that Arginine Butyrate merits further evaluation for the treatment of refractory sickle cell leg ulcers in larger trials.

N-acetylcysteine reduces oxidative stress in sickle cell patients.

Abstract: Oxidative stress is of importance in the pathophysiology of sickle cell disease (SCD). In this open label randomized pilot study the effects of oral N-acetylcysteine (NAC) on phosphatidylserine (PS) expression as marker of cellular oxidative damage (primary end point), and markers of hemolysis, coagulation and endothelial activation and NAC tolerability (secondary end points) were studied. Eleven consecutive patients (ten homozygous [HbSS] sickle cell patients, one HbSβ(0)-thalassemia patient) were randomly assigned to treatment with either 1,200 or 2,400 mg NAC daily during 6 weeks. The data indicate an increment in whole blood glutathione levels and a decrease in erythrocyte outer membrane phosphatidylserine exposure, plasma levels of advanced glycation end-products (AGEs) and cell-free hemoglobin after 6 weeks of NAC treatment in both dose groups. One patient did not tolerate the 2,400 mg dose and continued with the 1,200 mg dose. During the study period, none of the patients experienced painful crises or other significant SCD or NAC related complications. These data indicate that N-acetylcysteine treatment of sickle cell patients may reduce SCD related oxidative stress.

No improvement in suboptimal vitamin A status with a randomized, double-blind, placebo-controlled trial of vitamin A supplementation in children with sickle cell disease.

Abstract:
Suboptimal vitamin A status is prevalent in children with type SS sickle cell disease (SCD-SS) and is associated with hospitalizations and poor growth and hematologic status. The supplemental vitamin A dose that optimizes suboptimal vitamin A status in this population is unknown.

The efficacy of Recommended Dietary Allowance (RDA) doses (based on age and sex) of vitamin A (300, 400, or 600 μg retinyl palmitate/d) or vitamin A + zinc (10 or 20 mg zinc sulfate/d) compared with placebo to optimize vitamin A status was assessed in children aged 2.0-12.9 y with SCD-SS and a suboptimal baseline serum retinol concentration (<30 μg/dL).

In this randomized, double-blind, placebo-controlled trial, vitamin A status (serum retinol, prealbumin, retinol-binding protein, and relative-dose-response test) and disease-related illness events were assessed.

Twelve months of vitamin A supplementation at the doses recommended for healthy US children (based on age and sex) failed to improve serum retinol values in either group (vitamin A: n = 23; vitamin A + zinc: n = 18) compared with placebo (n = 21). By 12 mo, the increase (±SD) in serum retinol (3.6 ± 2.8 μg/dL) in those taking 600 μg vitamin A/d was significantly different from the decrease (±SD; -2.8 ± 2.4 μg/dL) in those taking 300 μg/d, which possibly suggests a dose-response relation (P < 0.05) with RDA doses.

Compared with placebo, 12 mo of vitamin A supplementation at the RDA for healthy children did not improve serum retinol values in children with SCD-SS, which possibly suggests that higher doses are needed. However, the existence of alternative conclusions emphasizes the need for future research.


Context: Because of wars, conflicts, persecutions, human rights violations, and humanitarian crises, about 84 million people are forcibly displaced around the world; the great majority of them live in low- and middle-income countries (LMICs). People living in humanitarian settings are affected by a constellation of stressors that threaten their mental health. Psychosocial interventions for people affected by humanitarian crises may be helpful to promote positive aspects of mental health, such as mental well-being, psychosocial functioning, coping, and quality of life. Previous reviews have focused on treatment and mixed promotion and prevention interventions. In this review, we focused on promotion of positive aspects of mental health.

To assess the effects of psychosocial interventions aimed at promoting mental health versus control conditions (no intervention, intervention as usual, or waiting list) in people living in LMICs affected by humanitarian crises.

Randomised controlled trials (RCTs) comparing psychosocial interventions versus control conditions (no intervention, intervention as usual, or waiting list) to promote positive aspects of mental health in adults and children living in LMICs affected by humanitarian crises. We excluded studies that enrolled participants based on a positive diagnosis of mental disorder (or based on a proxy of scoring above a cut-off score on a screening measure).

Effectiveness and specificity of a classroom-based group intervention in children and adolescents exposed to war in Lebanon.

Abstract: The purpose of this study was to examine the effectiveness and specificity of a classroom-based psychosocial intervention after war. All students (n=2500) of six villages in Southern Lebanon designated as most heavily exposed to war received a classroom-based intervention delivered by teachers, consisting of cognitive-behavioural and stress inoculation training strategies. A random sample of treated students (n=101) and a matched control group (n=93) were assessed one month post-war and one year later. Mental disorders and psychosocial stressors were assessed using the Diagnostic Interview for Children and Adolescents - Revised with children and parents. War exposure was measured using the War Events Questionnaire. The prevalence of major depressive disorder (MDD), separation anxiety disorder (SAD) and post-traumatic stress disorder (PTSD) was examined pre-war, one month post-war (pre-intervention), and one year post-war. Specificity of treatment was determined by rating teachers' therapy diaries. The rates of disorders peaked one month post-war and decreased over one year. There was no significant effect of the intervention on the rates of MDD, SAD or PTSD. Post-war MDD, SAD and PTSD were associated with pre-war SAD and PTSD, family violence parameters, financial problems and witnessing war events. These findings have significant policy and public health implications, given current practices of delivering universal interventions immediately post-war.

School-based mental health intervention for children affected by political violence in Indonesia: a cluster randomized trial.

Abstract:
Little is known about the efficacy of mental health interventions for children exposed to armed conflicts in low- and middle-income settings. Childhood mental health problems are difficult to address in situations of ongoing poverty and political instability.

To assess the efficacy of a school-based intervention designed for conflict-exposed children, implemented in a low-income setting.

A cluster randomized trial involving 495 children (81.4% inclusion rate) who were a mean (SD) age of 9.9 (1.3) years, were attending randomly selected schools in political violence-affected communities in Poso, Indonesia, and were screened for exposure (> or = 1 events), posttraumatic stress disorder, and anxiety symptoms compared with a wait-listed control group. Nonblinded assessment took place before, 1 week after, and 6 months after treatment between March and December 2006.

Fifteen sessions, over 5 weeks, of a manualized, school-based group intervention, including trauma-processing activities, cooperative play, and creative-expressive elements, implemented by locally trained paraprofessionals.

We assessed psychiatric symptoms using the Child Posttraumatic Stress Scale, Depression Self-Rating Scale, the Self-Report for Anxiety Related Disorders 5-item version, and the Children's Hope Scale, and assessed function impairment as treatment outcomes using standardized symptom checklists and locally developed rating scales.

Correcting for clustering of participants within schools, we found significantly more improvement in posttraumatic stress disorder symptoms (mean change difference, 2.78; 95% confidence interval [CI], 1.02 to 4.53) and maintained hope (mean change difference, -2.21; 95% CI, -3.52 to -0.91) in the treatment group than in the wait-listed group. Changes in traumatic idioms (stress-related physical symptoms) (mean change difference, 0.50; 95% CI, -0.12 to 1.11), depressive symptoms (mean change difference, 0.70; 95% CI, -0.08 to 1.49), anxiety (mean change difference, 0.12; 95% CI, -0.31 to 0.56), and functioning (mean change difference, 0.52; 95% CI, -0.43 to 1.46) were not different between the treatment and wait-listed groups.

In this study of children in violence-affected communities, a school-based intervention reduced posttraumatic stress symptoms and helped maintain hope, but did not reduce traumatic-stress related symptoms, depressive symptoms, anxiety symptoms, or functional impairment.

isrctn.org Identifier: ISRCTN25172408.

Preparing families of children with special health care needs for disasters: an education intervention.

Abstract: Children with special health care needs pose a special challenge in post-disaster response. Current research suggests that the general population is not adequately prepared for a major disaster event, with members of vulnerable populations even less prepared. The purpose of this study was to determine the short-term effectiveness of a brief patient education intervention aimed at increasing levels of disaster preparedness among families of special health care needs children. One hundred twenty-one families were randomly assigned to either intervention or intervention plus incentive group. Families were surveyed prior to the intervention using a previously published instrument on family preparedness, and at 30-45 days post-intervention. A Preparedness Score was assigned to each family based on the number of items completed on the preparedness instrument. Significant differences were found between pre- and posttest scores for families that received the intervention, regardless of whether or not an incentive item was provided. Posttest scores were significantly higher than pretest scores, suggesting that the intervention was successful in increasing short-term overall levels of family preparedness in this population.

Does combining infant stimulation with emergency feeding improve psychosocial outcomes for displaced mothers and babies? A controlled evaluation from northern Uganda.

Abstract: Combined psychosocial and nutrition interventions improve the development of infants. However, there is a paucity of studies examining the effectiveness of such interventions in humanitarian settings. This article examines the impact of combining a group-based psychosocial intervention with an existing emergency feeding program for internally displaced mothers in Northern Uganda. The intervention consisted of mother and baby group sessions and home visits for mothers attending 3 emergency feeding centers. Psychosocial outcomes were compared with a contrast group of mothers who received nutritional support alone. The outcomes investigated were infant stimulation and maternal mood. After controlling for the effects of interview site and baseline scores, mothers in the intervention group (n = 70) showed greater involvement with their babies, more availability of play materials, and less sadness and worry at follow-up in comparison to the contrast group (n = 77). The intervention was acceptable to the mothers and easily taught. A proportion of the mothers chose to continue the intervention spontaneously with other mothers in their neighbourhoods. Further research needs to be done to validate these preliminary findings and explore the longer term impact on child growth and intellectual development as well as maternal mood.

Group mental health interventions in civilian populations in war-conflict areas: a Lebanese pilot study.

Abstract:
Cognitive behavioral (CB) group therapy is an effective therapeutic intervention to treat war-related trauma. The aim of this pilot study was to describe the effects of conducting CB group therapy in a civilian population exposed to war in southern Lebanon.

Participants presenting with psychiatric symptoms attended an 8-week CB group therapy intervention adapted to the Lebanese culture. Observations from therapists' field notes were reviewed and grouped into commonalities.

A majority of the total participants (N = 10) reported satisfaction with the CB therapy and a decrease in symptoms. Field notes revealed positive group interactions (i.e., sharing information, cohesiveness), therapeutic benefits (i.e., symptom identification, destigmatizing mental illness, learning coping strategies), and barriers to attendance (i.e., stigma, personal constraints).

CB group therapy is a promising intervention for civilian survivors of war trauma. Challenges to conducting such interventions in a war-conflict area are discussed. Future research and intervention planning should address challenges faced during this study to better meet mental health needs.

Effectiveness RCT of a CBT intervention for youths who lost parents in the Sichuan, China, earthquake.

Abstract:
Many children who lost parents in the 2008 earthquake in Sichuan Province, China, experienced symptoms of posttraumatic stress disorder (PTSD) and depression. This randomized controlled study compared the treatment effectiveness of short-term cognitive-behavioral therapy (CBT) with a general supportive intervention and with a control group of nontreatment. METHODS; Thirty-two Chinese adolescents were randomly assigned to three treatment groups. Participants were compared for psychological resilience (Connor-Davidson Resilience Scale), symptoms of PTSD (Children's Revised Impact of Events Scale), and depression (Center for Epidemiologic Studies Depression Scale) at baseline, after treatment, and three-month follow-up.

CBT was effective in reducing PTSD and depressive symptoms and improved psychological resilience. General support was more effective than no intervention in improving psychological resilience.

Short-term CBT group intervention seems to be a robust intervention for natural disaster victims. Short-term CBT group intervention was more effective than the general supportive intervention and the no-treatment group in enhancing psychological resilience and reducing PTSD and depression among adolescents who had lost parents in the earthquake. The general supportive intervention was effective only in improving psychological resilience.

School-based mental health intervention for children in war-affected Burundi: a cluster randomized trial.

Abstract:
Armed conflicts are associated with a wide range of impacts on the mental health of children and adolescents. We evaluated the effectiveness of a school-based intervention aimed at reducing symptoms of posttraumatic stress disorder, depression, and anxiety (treatment aim); and improving a sense of hope and functioning (preventive aim).

We conducted a cluster randomized trial with 329 children in war-affected Burundi (aged 8 to 17 (mean 12.29 years, standard deviation 1.61); 48% girls). One group of children (n = 153) participated in a 15-session school-based intervention implemented by para-professionals, and the remaining 176 children formed a waitlist control condition. Outcomes were measured before, one week after, and three months after the intervention.

No main effects of the intervention were identified. However, longitudinal growth curve analyses showed six favorable and two unfavorable differences in trajectories between study conditions in interaction with several moderators. Children in the intervention condition living in larger households showed decreases on depressive symptoms and function impairment, and those living with both parents showed decreases on posttraumatic stress disorder and depressive symptoms. The groups of children in the waitlist condition showed increases in depressive symptoms. In addition, younger children and those with low levels of exposure to traumatic events in the intervention condition showed improvements on hope. Children in the waitlist condition who lived on their original or newly bought land showed improvements in hope and function impairment, whereas children in the intervention condition showed deterioration on these outcomes.

Given inconsistent effects across studies, findings do not support this school-based intervention as a treatment for posttraumatic stress disorder and depressive symptoms in conflict-affected children. The intervention appears to have more consistent preventive benefits, but these effects are contingent upon individual (for example, age, gender) and contextual (for example, family functioning, state of conflict, displacement) variables. Results suggest the potential benefit of school-based preventive interventions particularly in post-conflict settings.

The study was registered as ISRCTN42284825.

The Youth Readiness Intervention for war-affected youth.

Abstract:
Mental disorders are among the largest contributors to the global burden of disease. Since the cessation of the Sierra Leonean civil war in 2002, there have been few mental health resources available for war-affected youth. Co-occurring psychological problems are commonly reported by youth in the post-conflict setting, suggesting a need for evidence-based interventions that cater to comorbid psychological difficulties. This feasibility study outlines the implementation and evaluation of a mixed-methods approach for developing and piloting a culturally grounded group mental health treatment-the Youth Readiness Intervention (YRI)-for war-affected Sierra Leonean youth.

Participating youth (N = 32; 50% female; ages, 15-24 years) were allocated to one of four gender- and age-stratified groups, facilitated by gender-matched Sierra Leonean interventionists. The intervention comprised adapted cognitive behavioral therapy techniques to address issues pertinent to war-affected youth. Analyses comprised assessments of reliable symptom change, mental health, functional adaptation, and interventionist fidelity outcomes.

The YRI was found to be acceptable, feasible and associated with reliable changes in internalizing and externalizing symptoms and improvements in functional impairments and emotion regulation (mean effect size, d = .64).

Youth struggling with the mental health consequences of past trauma due to war merit special attention. The YRI presents a feasible and acceptable intervention for use in this low resource setting. A randomized controlled trial is planned to further test intervention effectiveness and scalability.

Effectiveness of Trauma-Focused Cognitive Behavioral Therapy Among Trauma-Affected Children in Lusaka, Zambia: A Randomized Clinical Trial.

Abstract:
Orphans and vulnerable children (OVC) are at high risk for experiencing trauma and related psychosocial problems. Despite this, no randomized clinical trials have studied evidence-based treatments for OVC in low-resource settings.

To evaluate the effectiveness of lay counselor-provided trauma-focused cognitive behavioral therapy (TF-CBT) to address trauma and stress-related symptoms among OVC in Lusaka, Zambia.

This randomized clinical trial compared TF-CBT and treatment as usual (TAU) (varying by site) for children recruited from August 1, 2012, through July 31, 2013, and treated until December 31, 2013, for trauma-related symptoms from 5 community sites within Lusaka, Zambia. Children were aged 5 through 18 years and had experienced at least one traumatic event and reported significant trauma-related symptoms. Analysis was with intent to treat.

The intervention group received 10 to 16 sessions of TF-CBT (n = 131). The TAU group (n = 126) received usual community services offered to OVC.

The primary outcome was mean item change in trauma and stress-related symptoms using a locally validated version of the UCLA Posttraumatic Stress Disorder Reaction Index (range, 0-4) and functional impairment using a locally developed measure (range, 0-4). Outcomes were measured at baseline and within 1 month after treatment completion or after a waiting period of approximately 4.5 months after baseline for TAU.

At follow-up, the mean item change in trauma symptom score was -1.54 (95% CI, -1.81 to -1.27), a reduction of 81.9%, for the TF-CBT group and -0.37 (95% CI, -0.57 to -0.17), a reduction of 21.1%, for the TAU group. The mean item change for functioning was -0.76 (95% CI, -0.98 to -0.54), a reduction of 89.4%, and -0.54 (95% CI, -0.80 to -0.29), a reduction of 68.3%, for the TF-CBT and TAU groups, respectively. The difference in change between groups was statistically significant for both outcomes (P < .001). The effect size (Cohen d) was 2.39 for trauma symptoms and 0.34 for functioning. Lay counselors participated in supervision and assessed whether the intervention was provided with fidelity in all 5 community settings.

The TF-CBT adapted for Zambia substantially decreased trauma and stress-related symptoms and produced a smaller improvement in functional impairment among OVC having experienced high levels of trauma.

clinicaltrials.gov Identifier: NCT01624298.

Community-based mental health treatments for survivors of torture and militant attacks in Southern Iraq: a randomized control trial.

Abstract:
Systematic violence is a long-standing problem in Iraq. Research indicates that survivors often experience multiple mental health problems, and that there is a need for more rigorous research that targets symptoms beyond post-traumatic stress (PTS). Our objective was to test the effectiveness of two counseling therapies in Southern Iraq in addressing multiple mental health problems among survivors of systematic violence: (1) a transdiagnostic intervention (Common Elements Treatment Approach or CETA); and (2) cognitive processing therapy (CPT). The therapies were provided by non-specialized health workers since few MH professionals are available to provide therapy in Iraq.

This was a randomized, parallel, two site, two-arm (1:1 allocation), single-blinded, wait-list controlled (WLC) trial of CETA in one site (99 CETA, 50 WLC), and CPT in a second site (129 CPT, 64 WLC). Eligibility criteria were elevated trauma symptoms and experience of systematic violence. The primary and secondary outcomes were trauma symptoms and dysfunction, respectively, with additional assessment of depression and anxiety symptoms. Non-specialized health workers (community mental health worker, CMHW) provided the interventions in government-run primary health centers. Treatment effects were determined using longitudinal, multilevel models with CMHW and client as random effects, and a time by group interaction with robust variance estimation, to test for the net difference in mean score for each outcome between the baseline and follow up interview. Multiple imputation techniques were used to account for missingness at the item level and the participant level. All analyses were conducted using Stata 12.

The CETA intervention showed large effect sizes for all outcomes. The CPT intervention showed moderate effects sizes for trauma and depression, with small to no effect for anxiety or dysfunction, respectively.

Both CETA and CPT appear to benefit survivors of systematic violence in Southern Iraq by reducing multiple mental health symptoms, with CETA providing a very large benefit across a range of symptoms. Non-specialized health workers were able to treat comorbid symptoms of trauma, depression and anxiety, and dysfunction among survivors of systematic violence who have limited access to mental health professionals. The trial further supports the use of evidence-based therapies in lower-resource settings.

This trial was registered at ClinicalTrials.gov on 16 July 2010 with an identifier of NCT01177072 as the Study of Effectiveness of Mental Health Interventions among Torture Survivors in Southern Iraq. The study protocol can be downloaded from the following website: http://tinyurl.com/CETA-Iraq-Protocol . In the protocol, the CETA intervention is given a different name: components-based intervention or CBI.


Context: Prevention of obesity in adolescents is an international public health priority. The prevalence of overweight and obesity is over 25% in North and South America, Australia, most of Europe, and the Gulf region. Interventions that aim to prevent obesity involve strategies that promote healthy diets or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective, and numerous new studies have been published over the last five years since the previous version of this Cochrane Review.

To assess the effects of interventions that aim to prevent obesity in adolescents by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events.

Randomised controlled trials in adolescents (mean age 12 years and above but less than 19 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance.

New Moves: a school-based obesity prevention program for adolescent girls.

Abstract:
This study tests the feasibility of an innovative school-based program for obesity prevention among adolescent girls. New Moves was implemented as a multicomponent, girls-only, high-school physical education class.

Six schools were equally randomized into intervention and control conditions. Data were collected at baseline, postintervention, and 8-month follow-up to assess program impact on physical activity, eating patterns, self-perceptions, and body mass index (BMI) among 89 girls in the intervention and 112 girls in the control conditions. Program evaluation also included interviews with school staff, parent surveys, and participant interviews and process evaluation surveys.

The feasibility of implementing New Moves was high, as indicated by strong satisfaction among participants, parents, and school staff, and by program sustainability. Participants perceived a positive program impact on their physical activity, eating patterns, and self-image. Girls in the intervention significantly progressed in their stage of behavioral change for physical activity from baseline to follow-up. However, for the majority of outcome variables, differences between intervention and control schools at postintervention and follow-up were not statistically significant.

New Moves was well received and fills a needed niche within school physical education programs. An expanded intervention and evaluation is needed to enhance and assess long-term program effectiveness.

Improvements in heart health behaviors and reduction in coronary artery disease risk factors in urban teenaged girls through a school-based intervention: the PATH program.

Abstract:
We sought to assess the effects of a school-based intervention program on cardiovascular disease risk factors in urban girls.

We compared heart health knowledge, health behaviors, cardiovascular risk factors, and physical fitness among a group of 442 multiethnic teenaged girls (310 experimental participants vs 132 control participants). Testing was conducted before and after a 12-week program of vigorous exercises integrated with lectures and discussions on diet, exercise, stress, and smoking.

Significant differences in body fat, systolic and diastolic blood pressure, heart health knowledge, and whether breakfast was eaten were observed between experimental participants and control participants.

An integrated program of exercise and heart health-related lectures and discussions had a beneficial effect on health knowledge, health behaviors, and onset of risk factors for coronary artery disease among urban girls.

Promotion of physical activity among high-school girls: a randomized controlled trial.

Abstract:
Many adolescent girls fail to meet national guidelines for physical activity, and the prevalence of obesity is increasing among this group. Our study examined the effects of a comprehensive school-based intervention on physical activity among high-school girls.

A group-randomized controlled field trial was conducted at 24 high schools. A school-based sample of 2744 girls (48.7% African American, 46.7% White) participated in a measurement protocol when they were in eighth and then ninth grade. A comprehensive physical activity intervention was designed to change the instructional program and the school environment to increase support for physical activity among girls.

At follow-up, 45% of girls in the intervention schools and 36% of girls in the control schools reported vigorous physical activity during an average of 1 or more 30-minute time blocks per day over a 3-day period.

A comprehensive school-based intervention can increase regular participation in vigorous physical activity among high-school girls.

Fit for Life Boy Scout badge: outcome evaluation of a troop and Internet intervention.

Abstract:
This study reports the results of a 9-week intervention on the physical activity levels of adolescent males.

Participants were 473 10- to 14-year-old Houston Boy Scouts (42 troops) with troops randomly assigned to intervention or control conditions. Data were collected in spring (16 troops) and fall (26 troop) waves during 2003. Intervention participants received a 9-week troop and Internet program to increase physical activity skills, self-efficacy and goal-setting. Physical activity was assessed at baseline, end of the intervention (Post#1) and post-6 months (Post#2) by accelerometer. Minutes of sedentary, light and moderate to vigorous physical activity were calculated. Repeated measure analyses were performed to test differences in physical activity over time between groups with participants nested in troops.

A three-way interaction (group * time * wave) that approached significance (P = 0.051) indicated a 12-min reduction in sedentary behavior among spring intervention participants. A significant three-way interaction (P = 0.011) (group * time * wave) indicated a 12-min increase in light intensity activity among the spring intervention group.

Participation in the Fit for Life badge program resulted in a trend towards a small decrease in sedentary behavior and increased light intensity physical activity among spring participants only. There was no effect on moderate to vigorous physical activity.

Randomized controlled trial of a primary care and home-based intervention for physical activity and nutrition behaviors: PACE+ for adolescents.

Abstract:
Many adolescents do not meet national guidelines for participation in regular moderate or vigorous physical activity (PA); limitations on sedentary behaviors; or dietary intake of fruits and vegetables, fiber, or total dietary fat. This study evaluated a health care-based intervention to improve these behaviors.

Randomized controlled trial.

Primary care with follow-up at home.

Eight hundred seventy-eight adolescent girls and boys aged 11 to 15 years.

Two experimental conditions: (1) Primary care, office-based, computer-assisted diet and PA assessment and stage-based goal setting followed by brief health care provider counseling and 12 months of monthly mail and telephone counseling and (2) a comparison condition addressing sun exposure protection.

Minutes per week of moderate plus vigorous PA measured by self-report and accelerometer; self-report of days per week of PA and sedentary behaviors; and percentage of energy from fat and servings per day of fruits and vegetables measured by three 24-hour diet recalls. Body mass index (calculated as weight in kilograms divided by the square of height in meters) was a secondary outcome.

Compared with adolescents in the sun protection condition, girls and boys in the diet and PA intervention significantly reduced sedentary behaviors (intervention vs control change, 4.3 to 3.4 h/d vs 4.2 to 4.4 h/d for girls, respectively [P = .001]; 4.2 to 3.2 h/d vs 4.2 to 4.3 h/d for boys, respectively [P = .001]). Boys reported more active days per week (intervention vs control change: 4.1 to 4.4 d/wk vs 3.8 to 3.8 d/w, respectively [P = .01]), and the number of servings of fruits and vegetables for girls approached significance (intervention vs control change, 3.5 to 4.2 servings/d vs 3.5 to 3.9 servings/d, respectively [P = .07]). No intervention effects were seen with percentage of calories from fat or minutes of PA per week. Percentage of adolescents meeting recommended health guidelines was significantly improved for girls for consumption of saturated fat (intervention vs control change, 23.4% to 41.0% vs 18.5% to 31%, respectively [relative risk, 1.33; 95% confidence interval, 1.01-1.68]) and for boys' participation in d/wk of PA (intervention vs control change, 45.3% to 55.4% vs 41.9% to 38.0%, respectively [relative risk, 1.47; 95% confidence interval, 1.19-1.75]). No between-group differences were seen in body mass index.

Improvements in some diet, PA, and sedentary behaviors in adolescents can be enabled through the use of a 1-year, integrated intervention using the computer, health provider counseling, mail, and telephone. The amount of intervention received may contribute to its efficacy.

Environmental interventions for eating and physical activity: a randomized controlled trial in middle schools.

Abstract:
Our objective was to evaluate the effects of environmental, policy, and social marketing interventions on physical activity and fat intake of middle school students on campus.

Twenty-four middle schools were randomly assigned to intervention or control conditions. Baseline measures were collected in spring 1997, and interventions were conducted during the 1997-1998 and 1998-1999 school years SETTING/PARTICIPATION: The schools had mean enrollments of 1109, with 44.5% nonwhite students. Over 2 years, physical activity interventions were designed to increase physical activity in physical education classes and throughout the school day. Nutrition interventions were designed to provide and market low-fat foods at all school food sources, including cafeteria breakfasts and lunches, a la carte sources, school stores, and bag lunches. School staff and students were engaged in policy change efforts, but there was no classroom health education.

Primary outcomes were measured by direct observation and existing records.

Randomized regression models (N =24 schools) revealed a significant intervention effect for physical activity for the total group (p <0.009) and boys (p <0.001), but not girls (p <0.40). The intervention was not effective for total fat (p <0.91) or saturated fat (p <0.79). Survey data indicated that the interventions reduced reported body mass index for boys (p <0.05).

Environmental and policy interventions were effective in increasing physical activity at school among boys but not girls. The interventions were not effective in reducing fat intake at school. School environmental and policy interventions have the potential to improve health behavior of the student population, but barriers to full implementation need to be better understood and overcome.

Evaluation of a two-year middle-school physical education intervention: M-SPAN.

Abstract:
School physical education (PE) is highly recommended as a means of promoting physical activity, and randomized studies of health-related PE interventions in middle schools have not been reported. We developed, implemented, and assessed an intervention to increase physical activity during middle-school PE classes.

Twenty-four middle schools (approximately 25,000 students, 45% nonwhite) in Southern California participated in a randomized trial. Schools were assigned to intervention (N = 12) or control (N = 12) conditions, and school was the unit of analysis. A major component of the intervention was a 2-yr PE program, which consisted of curricular materials, staff development, and on-site follow-up. Control schools continued usual programs. Student activity and lesson context were observed in 1849 PE lessons using a validated instrument during baseline and intervention years 1 and 2.

The intervention significantly (P = 0.02) improved student moderate to vigorous physical activity (MVPA) in PE, by approximately 3 min per lesson. Effects were cumulative; by year 2 intervention schools increased MVPA by 18%. Effect sizes were greater for boys (d = 0.98; large) than girls (d = 0.68; medium).

A standardized program increased MVPA in middle schools without requiring an increase in frequency or duration of PE lessons. Program components were well received by teachers and have the potential for generalization to other schools. Additional strategies may be needed for girls.

Girls on the move program to increase physical activity participation.

Abstract:
Because physical inactivity poses serious health risks, interventions are urgently needed to reverse the increasingly sedentary lifestyles of adolescent girls.

The aim of this study was to determine the feasibility of "Girls on the Move," an individually tailored computerized physical activity (PA) program plus nurse counseling intervention, in increasing PA.

A pretest-posttest control group design was used with 77 racially diverse sedentary girls in Grades 6, 7, and 8 from two middle schools. Each of the instructional grades was randomly assigned to either an intervention or control condition. After completing computerized questionnaires, each girl in the control group received a handout listing the PA recommendations. To encourage PA, each girl in the intervention group received computerized, individually tailored feedback messages based on her responses to the questionnaires, individual counseling from the school's pediatric nurse practitioner (PNP), and telephone calls and mailings from a trained research assistant. At 12 weeks, girls in both groups responded to the questionnaires.

No differences in self-reported PA emerged between the intervention and control groups at Weeks 1 (baseline) and 12 (postintervention). Repeated measures ANOVA showed a significant interaction between group and time for social support for PA, F(1, 69) = 5.73, p = .019, indicating that the intervention group had significantly greater social support across time than did the control group. From baseline to postintervention, social support increased for the intervention group but decreased for the control group.

Reasons for the lack of significant differences between the groups on the PA measures were cited. Important information that could inform subsequent studies that test interventions to increase youth PA was acquired from conducting this study. Future efforts to increase PA participation might include this approach for enhancing social support for PA.

Enhancing physical and social environments to reduce obesity among public housing residents: rationale, trial design, and baseline data for the Healthy Families study.

Abstract: Intervention programs that change environments have the potential for greater population impact on obesity compared to individual-level programs. We began a cluster randomized, multi-component multi-level intervention to improve weight, diet, and physical activity among low-socioeconomic status public housing residents. Here we describe the rationale, intervention design, and baseline survey data. After approaching 12 developments, ten were randomized to intervention (n=5) or assessment-only control (n=5). All residents in intervention developments are welcome to attend any intervention component: health screenings, mobile food bus, walking groups, cooking demonstrations, and a social media campaign; all of which are facilitated by community health workers who are residents trained in health outreach. To evaluate weight and behavioral outcomes, a subgroup of female residents and their daughters age 8-15 were recruited into an evaluation cohort. In total, 211 households completed the survey (RR=46.44%). Respondents were Latino (63%), Black (24%), and had ≤ high school education (64%). Respondents reported ≤2 servings of fruits & vegetables/day (62%), visiting fast food restaurants 1+ times/week (32%), and drinking soft drinks daily or more (27%). The only difference between randomized groups was race/ethnicity, with more Black residents in the intervention vs. control group (28% vs. 19%, p=0.0146). Among low-socioeconomic status urban public housing residents, we successfully recruited and randomized families into a multi-level intervention targeting obesity. If successful, this intervention model could be adopted in other public housing developments or entities that also employ community health workers, such as food assistance programs or hospitals.

A national school-based health lifestyles interventions among Chinese children and adolescents against obesity: rationale, design and methodology of a randomized controlled trial in China.

Abstract:
The prevalence of obesity among children and adolescents has been rapidly rising in Mainland China in recent decades, both in urban and rural areas. There is an urgent need to develop effective interventions to prevent childhood obesity. Limited rigid data regarding children and adolescent overweight prevention in China are available. A national random controlled school-based obesity intervention program was developed in the mainland of China.

The study was designed as a national multi-centered cluster randomized controlled trial involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in China. In each center, about 12-16 primary and secondary schools, with totally at least 10000 participants were randomly selected (Primary: Secondary = 1:1). All of the selected schools were randomly allocated to either intervention or control group (Intervention: Control = 1:1).The multi-components school-based and family-involved scheme was conducted within the intervention group for 9 month, while students in the control group followed their usual health practice. The intervention consisted of four components: a) Create supportive school and family environment, b) Health lifestyles education and related compulsory physical activities, c) Instruct and promote school physical education, d) Self-monitor obesity related behaviors. Four types of outcomes including anthropometric, behavioral, blood chemical and physical fitness were measured to assess the effectiveness of the intervention program.

This is the first and largest multi-centered school-based obesity intervention program with the consideration of geographical and social-demographic characteristics of the rapidly increased obesity prevalence of Chinese children and adolescent. The intervention is based on Social Cognitive Theory and Social-Ecological Model of Health, and follows a stepwise approach guided by PRECEDE-PROCEED (P-P) Model and Intervention Map. The results of and lesson learned from this study will help guide future school-based national childhood obesity prevention programs in Mainland China.

January 22, 2015;

NCT02343588.


Context: Prevention of obesity in children is an international public health priority given the prevalence of the condition (and its significant impact on health, development and well-being). Interventions that aim to prevent obesity involve behavioural change strategies that promote healthy eating or 'activity' levels (physical activity, sedentary behaviour and/or sleep) or both, and work by reducing energy intake and/or increasing energy expenditure, respectively. There is uncertainty over which approaches are more effective and numerous new studies have been published over the last five years, since the previous version of this Cochrane review.

To assess the effects of interventions that aim to prevent obesity in children by modifying dietary intake or 'activity' levels, or a combination of both, on changes in BMI, zBMI score and serious adverse events.

Randomised controlled trials in children (mean age 5 years and above but less than 12 years), comparing diet or 'activity' interventions (or both) to prevent obesity with no intervention, usual care, or with another eligible intervention, in any setting. Studies had to measure outcomes at a minimum of 12 weeks post baseline. We excluded interventions designed primarily to improve sporting performance.

Reducing obesity via a school-based interdisciplinary intervention among youth: Planet Health.

Abstract:
To evaluate the impact of a school-based health behavior intervention known as Planet Health on obesity among boys and girls in grades 6 to 8.

Randomized, controlled field trial with 5 intervention and 5 control schools. Outcomes were assessed using preintervention (fall 1995) and follow-up measures (spring 1997), including prevalence, incidence, and remission of obesity.

A group of 1295 ethnically diverse grade 6 and 7 students from public schools in 4 Massachusetts communities.

Students participated in a school-based interdisciplinary intervention over 2 school years. Planet Health sessions were included within existing curricula using classroom teachers in 4 major subjects and physical education. Sessions focused on decreasing television viewing, decreasing consumption of high-fat foods, increasing fruit and vegetable intake, and increasing moderate and vigorous physical activity.

Obesity was defined as a composite indicator based on both a body mass index and a triceps skinfold value greater than or equal to age- and sex-specific 85th percentiles. Because schools were randomized, rather than students, the generalized estimating equation method was used to adjust for individual-level covariates under cluster randomization.

The prevalence of obesity among girls in intervention schools was reduced compared with controls, controlling for baseline obesity (odds ratio, 0.47; 95% confidence interval, 0.24-0.93; P = .03), with no differences found among boys. There was greater remission of obesity among intervention girls vs. control girls (odds ratio, 2.16; 95% confidence interval, 1.07-4.35; P = .04). The intervention reduced television hours among both girls and boys, and increased fruit and vegetable consumption and resulted in a smaller increment in total energy intake among girls. Reductions in television viewing predicted obesity change and mediated the intervention effect. Among girls, each hour of reduction in television viewing predicted reduced obesity prevalence (odds ratio, 0.85; 95% confidence interval, 0.75-0.97; P = .02).

Planet Health decreased obesity among female students, indicating a promising school-based approach to reducing obesity among youth.

Increasing fruit and vegetable intake and decreasing fat and sugar intake in families at risk for childhood obesity.

Abstract:
The goal of this study was to evaluate the effect of a parent-focused behavioral intervention on parent and child eating changes and on percentage of overweight changes in families that contain at least one obese parent and a non-obese child.

Families with obese parents and non-obese children were randomized to groups in which parents were provided a comprehensive behavioral weight-control program and were encouraged to increase fruit and vegetable intake or decrease intake of high-fat/high-sugar foods. Child materials targeted the same dietary changes as their parents without caloric restriction.

Changes over 1 year showed that treatment influenced targeted parent and child fruit and vegetable intake and high-fat/high-sugar intake, with the Increase Fruit and Vegetable group also decreasing their consumption of high-fat/high-sugar foods. Parents in the increased fruit and vegetable group showed significantly greater decreases in percentage of overweight than parents in the decreased high-fat/high-sugar group.

These results suggest that focusing on increasing intake of healthy foods may be a useful approach for nutritional change in obese parents and their children.

Evaluation of implementation and effect of primary school based intervention to reduce risk factors for obesity.

Abstract:
To implement a school based health promotion programme aimed at reducing risk factors for obesity and to evaluate the implementation process and its effect on the school.

Data from 10 schools participating in a group randomised controlled crossover trial were pooled and analysed.

10 primary schools in Leeds.

634 children (350 boys and 284 girls) aged 7-11 years.

Response rates to questionnaires, teachers' evaluation of training and input, success of school action plans, content of school meals, and children's knowledge of healthy living and self reported behaviour.

All 10 schools participated throughout the study. 76 (89%) of the action points determined by schools in their school action plans were achieved, along with positive changes in school meals. A high level of support for nutrition education and promotion of physical activity was expressed by both teachers and parents. 410 (64%) parents responded to the questionnaire concerning changes they would like to see implemented in school. 19 out of 20 teachers attended the training, and all reported satisfaction with the training, resources, and support. Intervention children showed a higher score for knowledge, attitudes, and self reported behaviour for healthy eating and physical activity.

This programme was successfully implemented and produced changes at school level that tackled risk factors for obesity.

Randomised controlled trial of primary school based intervention to reduce risk factors for obesity.

Abstract:
To assess if a school based intervention was effective in reducing risk factors for obesity.

Group randomised controlled trial.

10 primary schools in Leeds.

634 children aged 7-11 years.

Teacher training, modification of school meals, and the development of school action plans targeting the curriculum, physical education, tuck shops, and playground activities.

Body mass index, diet, physical activity, and psychological state.

Vegetable consumption by 24 hour recall was higher in children in the intervention group than the control group (weighted mean difference 0.3 portions/day, 95% confidence interval 0.2 to 0.4), representing a difference equivalent to 50% of baseline consumption. Fruit consumption was lower in obese children in the intervention group (-1.0, -1.8 to -0.2) than those in the control group. The three day diary showed higher consumption of high sugar foods (0.8, 0.1 to 1.6)) among overweight children in the intervention group than the control group. Sedentary behaviour was higher in overweight children in the intervention group (0.3, 0.0 to 0.7). Global self worth was higher in obese children in the intervention group (0.3, 0.3 to 0.6). There was no difference in body mass index, other psychological measures, or dieting behaviour between the groups. Focus groups indicated higher levels of self reported behaviour change, understanding, and knowledge among children who had received the intervention.

Although it was successful in producing changes at school level, the programme had little effect on children's behaviour other than a modest increase in consumption of vegetables.

Girls health Enrichment Multi-site Studies (GEMS): new approaches to obesity prevention among young African-American girls.

Abstract: The Girls health Enrichment Multi-site Studies (GEMS) is an obesity prevention research program sponsored by the National Heart, Lung, and Blood Institute (NHLBI), targeting young African-American girls. Expert groups have suggested that the high prevalence of obesity in African-American women could be a contributing factor to their excess morbidity and mortality from cardiovascular disease compared to women from other ethnic groups. To address the issue of obesity and its origins in African-American women, the NHLBI Growth and Health Study (NGHS) was initiated to investigate factors related to the development of obesity and associated cardiovascular disease risk factors in a cohort of young African-American and White girls, aged 9 and 10 years. Findings from NGHS, and the realization that obesity had become a major public health problem, subsequently led to a 2-phase, 7-year collaborative obesity prevention research program, the Girls health Enrichment Multi-site Studies (GEMS). Initiated in 1999, Phase 1 of GEMS was conducted collaboratively among 4 participating field centers, a coordinating center, and the NHLBI project office to conduct formative assessment research and to pilot test, over a 12-week period, interventions that might be effective in reducing the rate of weight gain in African-American girls, aged 8-10 years. Over a 2-year period, Phase 2 of GEMS will test the interventions that appear most promising in preventing excessive weight gain in young African-American girls. The experiences of the GEMS pilot studies will help guide future intervention research for obesity prevention beginning in childhood. This report describes the background and rationale for the GEMS initiative. This journal supplement describes the experiences of the GEMS Phase 1 program.

Common design elements of the Girls health Enrichment Multi-site Studies (GEMS).

Abstract: The Girls health Enrichment Multi-site Studies (GEMS) was a multi-center research program created for the purpose of testing interventions designed to prevent excess weight gain by African-American girls, as they enter and proceed through puberty. However, GEMS was not a "multi-center clinical trial" in the usual sense. Although these studies applied similar eligibility criteria, observed a similar follow-up schedule, and followed a similar measurement protocol, important differences existed, as well. Each field center developed its own intervention(s) and corresponding control, and tailored its study to the specific hypothesis being tested. Therefore, the study populations were somewhat different, with recruitment strategies that varied accordingly, and supplemental evaluations appropriate to the specific interventions were conducted on a site-specific basis. The purpose of this paper is to describe the common design elements of the GEMS Phase 1 pilot studies. This report presents the basic study design, a brief overview of the interventions, the measurements taken and their rationale, and procedures both for compiling the collaborative database, and performing site-specific analyses.

The Fun, Food, and Fitness Project (FFFP): the Baylor GEMS pilot study.

Abstract:
The Girls health Enrichment Multisite Studies (GEMS) Fun, Food, and Fitness Project (FFFP) was designed to prevent obesity among 8-year-old African-American girls.

Twelve-week, two-arm parallel group randomized controlled pilot study.

Summer day camp and homes in Houston, Texas.

Thirty-five girls and their parents or caregivers were randomly assigned to treatment (N=19) or control groups (N=16).

Girls in the intervention group attended a special 4-week summer day camp, followed by a special 8-week home Internet intervention for the girls and their parents. Control group girls attended a different 4-week summer day camp, followed by a monthly home Internet intervention, neither of which components included the GEMS-FFFP enhancements.

Body mass index (BMI), consumption of fruit, 100% fruit juice, and vegetables (FJV), physical activity.

After adjusting for baseline BMI, there were no significant differences in BMI between treatment and control group girls, either at the end of the 4-week summer day camp, or after the full 12-week intervention. By the end of the summer camp, the subgroup of treatment group girls heavier at baseline exhibited a trend (P<.08) toward lower BMI, compared to their heavier counterparts in the control group. Overall results at the end of the 12-week program demonstrated substantial, although not significant, differences between treatment and control groups in the hypothesized directions. On average, less than half the treatment sample logged onto the Website, which limited intervention dose.

Summer day camp appears to offer promise for initiating health behavior change. Effective methods must be developed and tested to enhance log-on rates among healthy children and their parents before Internet programs can achieve their potential.

Child- and parent-targeted interventions: the Memphis GEMS pilot study.

Abstract:
To assess the feasibility, acceptability, and outcomes of 2 versions of a culturally relevant, family-based intervention to prevent excess weight gain in pre-adolescent African-American girls.

Three-arm, 12-week parallel group randomized controlled pilot trial.

Community centers in Memphis, Tennessee.

Sixty African-American girls, aged 8 to 10 years, with a body mass index (BMI) > or = 25th percentile of the CDC growth charts, along with their parents/caregivers.

The active interventions involved highly interactive weekly group sessions with either girls (child-targeted program) or parents/caregivers (parent-targeted program). Content focused on knowledge and behavior change skills to promote healthy eating and increased physical activity. The comparison intervention focused on global self-esteem.

Given the lack of power and the limited time frame of the pilot study, outcomes were evaluated on the basis of implementation measures and changes in physical activity (accelerometer data), and in consumption of sweetened beverages and water, as estimated from questionnaires. Changes in body mass index, waist circumference, and body composition were also examined.

The Memphis GEMS pilot intervention met all recruitment, retention, implementation, and participation goals, and was given high rating by both participants and interventionists. With respect to the comparison intervention, girls in both the child-targeted and parent-targeted interventions demonstrated a trend toward reduced body mass index and waist circumference. In addition, girls in the active intervention groups reduced their consumption of sweetened beverages by 34%, increased their level of moderate-to-vigorous activity by 12%, and increased their serving; of water by 1.5%.

The findings from this pilot study demonstrated the feasibility, perceived acceptability, and efficacy of culturally relevant, obesity prevention interventions for pre-adolescent African-American girls and their parents/caregivers.

Evaluation of the institutionalization of the coordinated approach to child health (CATCH) in a U.S./Mexico border community.

Abstract: El Paso Coordinated Approach to Child Health (El Paso CATCH) was evaluated in 24 schools for outcome measures of moderate to vigorous physical activity (MVPA) during physical education (PE), content of PE lessons, content of school meals, and numerous process measures. Chi-square analyses compared frequency data across time for activity during PE and percentage fat in school meals. Descriptive summaries were used for process questionnaire results. Data were also compared to CATCH program goals. For most intervention schools, El Paso CATCH significantly increased MVPA, decreased fat in school meals, and decreased sodium in school breakfasts. However, some schools were not meeting the fat content goals for school lunches, and no schools met the vigorous physical activity (VPA) goals for PE or the sodium goals for school lunches.

Adoption and institutionalization of the Child and Adolescent Trial for Cardiovascular Health (CATCH) in El Paso, Texas.

Abstract: One goal of national health-promotion research is to disseminate and institutionalize experimentally tested programs in local communities. In 1997, the national Child and Adolescent Trial for Cardiovascular Health (CATCH) was chosen by the Paso del Norte Health Foundation as their first community-wide preventive health initiative for the El Paso, Texas/Juárez, México border region. With help from researchers at the University of Texas at Houston, evaluators from the University of Texas at El Paso, and the Region 19 Educational Services Center, CATCH was implemented in 18 Title I pilot schools. Known as the Coordinated Approach to Child Health 5 years later, the El Paso CATCH program has been embraced by the border community and reaches 108 elementary schools from New Mexico to West Central Texas. There are also plans to implement CATCH in Juárez. This article describes the institutionalization of CATCH in a predominately Hispanic, low income border region.