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2.1. Study Design | obesity | OBESITY | An 8-month two-arm randomized pilot trial was conducted. Sixty African American women with obesity were assigned to receive the | PMC9859082 |
2.2. Participants | obesity | OBESITY | Participants included 60 insufficiently active AA women with obesity aged 24–49 years. Specific inclusion criteria included: (a) self-identifying as an AA woman; (b) being between the ages 24 and 49 years; (c) having a BMI ≥ 30 kg·m | PMC9859082 |
2.4. Cultural Tailoring of the Intervention | Cultural tailoring was achieved through a comprehensives synthesis of the literature [ | PMC9859082 | ||
2.5. Description of the Smart Health Attention-Matched Wellness Comparison Intervention | Women assigned to the smartphone-delivered attention-matched wellness comparison condition received a surface-level culturally tailored health promotion intervention, entitled | PMC9859082 | ||
2.6. Measures | PMC9859082 | |||
2.6.1. Demographic Characteristics | Demographic characteristics (i.e., age, income, relationship status) were collected using a survey developed for the current study. | PMC9859082 | ||
2.6.5. Social Cognitive Theory Outcomes | Social Cognitive Theory constructs targeted by the intervention were assessed using previously published and validated surveys, described elsewhere [ | PMC9859082 | ||
2.7. Protocol | EVENTS, RECRUITMENT | Community-based strategies (i.e., email listservs, social media advertisements, in-person recruitment at community events) were used to recruit study participants. Interested individuals contacted the research team and were assessed for eligibility via a telephone interview or by completing an online eligibility screen... | PMC9859082 | |
2.8. Statistical Design | PMC9859082 | |||
2.8.1. Sample Size Considerations | The primary aim of this study was to examine acceptability and feasibility of the intervention, rather than to formally test the intervention’s efficacy. Accordingly, the choice of sample size was selected primarily to allow for testing and refinement of protocols and procedures (Aim 1), informal examination of between... | PMC9859082 | ||
2.8.2. Statistical Analyses | Univariate descriptive statistics (means, standard deviations, percentages, frequencies) were used to summarize demographic characteristics, To mitigate bias and the loss of statistical power due to attrition, we analyzed datasets created using multiple imputation (MI). We used a fully conditional specified imputation ... | PMC9859082 | ||
3. Results | PMC9859082 | |||
3.1. Participant Characteristics | Participants (n = 60) had a mean age of 38.4 ( | PMC9859082 | ||
3.2. Feasibility and Acceptability | PMC9859082 | |||
3.3. Physical Activity | The intervention group demonstrated substantially greater increases in self-reported minutes/week of MVPA compared to the comparison group at both the 4-month (model-estimated between-arm difference in change [b ± SE(b)] = 43.3 ± 17.7 min/week, With respect to meeting national PA guidelines, at the 4-month follow-up, 6... | PMC9859082 | ||
3.4. Cardiometabolic Risk Markers | Cardiometabolic risk outcomes are presented in | PMC9859082 | ||
3.5. Social Cognitive Theory Outcomes | As illustrated in | PMC9859082 | ||
4. Discussion | cardiometabolic disease | The current study examined the acceptability and feasibility of a smartphone-delivered PA intervention for AA women and explored between-group differences for patterns of change in cardiometabolic disease risk outcomes and hypothesized theoretical mediators. Overall, results for the feasibility and acceptability of the... | PMC9859082 | |
4.1. Feasibility and Acceptability | RECRUITMENT, RECRUITMENT | Feasibility and acceptability of the intervention were supported by numerous indices, including participant recruitment and retention, results of the post-intervention satisfaction survey, and app use. Recruitment efforts yielded an enrollment rate of 7.5 women/month. Although comparison of this enrollment rate to othe... | PMC9859082 | |
4.2. Physical Activity and Cardiometabolic Disease Risk Outcomes | weight loss, arterial stiffness | EVENTS, ARTERIAL STIFFNESS | Intervention participants self-reported greater MVPA increases than comparison group participants at both post-intervention assessments. Changes in self-reported energy expenditure followed a similar pattern. Self-reported MVPA changes from baseline to 4 months are comparable to improvements observed in a previous e- a... | PMC9859082 |
4.3. Psychosocial Outcomes | Substantially greater improvement in behavioral capability for PA for intervention participants suggests that the intervention curriculum was successful in enhancing knowledge of national PA guidelines, the types of activities that constitute aerobic PA, and the health benefits of aerobic PA. We also observed small-to-... | PMC9859082 | ||
4.4. Limitations, Strengths, and Future Directions | PA behaviors | RECRUITMENT, BLIND | The study’s findings are encouraging, but it is important to recognize potential limitations. The primary focus for this stage of intervention development was on feasibility and acceptability of the smartphone-delivered intervention, rather than efficacy testing. Accordingly, when interpreting PA, cardiometabolic, and ... | PMC9859082 |
5. Conclusions | obesity, cardiometabolic disease | OBESITY | This study demonstrated high acceptability and feasibility, and yielded promising findings regarding the intervention’s associations with increased PA and reduced cardiometabolic disease risk among insufficiently active AA women with obesity. | PMC9859082 |
Author Contributions | Conceptualization R.P.J., B.E.A., C.K. and M.A.A.; Supervision, R.P.J., Formal Analysis M.T.; Software, K.H.; Funding Acquisition, R.P.J., M.T., B.E.A., S.V.-L., M.A.A., G.A.G. and C.K.; Writing—orgininal draft, R.P.J.; Writing—review and editing, S.P.H. All authors have read and agreed to the published version of the ... | PMC9859082 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) of Arizona State University (STUDY00006163; Approved 4-24-2017). | PMC9859082 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC9859082 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC9859082 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC9859082 | ||
Purpose | ANTERIOR | Wii Fit exergames have been less commonly used for the rehabilitation of athletes after Anterior Cruciate Ligament Reconstruction (ACLR). This study aims to investigate the effects of an expert system using Wii Fit exergames compared to conventional rehabilitation following ACLR. A forward-chaining rule-based expert sy... | PMC10386671 | |
Materials and methods | Twenty eligible athletes aged 20–30 who underwent ACLR were enrolled in this study and randomly assigned to two groups; and received 12 sessions of either Wii Fit exergames as Wii group ( | PMC10386671 | ||
Results | knee flexion range, TG, knee effusion, pain | The main outcomes consisted of pain (Visual Analogue Scale (VAS)), knee effusion, knee flexion range (KFR), thigh girth (TG), single-leg hop for distance (SLHD), and for time (SLHT), static and dynamic balance tests. Both groups had considerable improvement in all outcomes, also there were significantly differences bet... | PMC10386671 | |
Conclusions | post-ACLR, effusion, pain | EFFUSION | The findings showed that using Wii Fit exergames in post-ACLR patients reduced pain and effusion while also improving function and balance significantly. Iranian Registry of Clinical Trials registration number is IRCT20191013045090N1, and the registration date is 03-03-2020. | PMC10386671 |
Keywords | PMC10386671 | |||
Introduction | knee flexion, knee effusion, pain | ANTERIOR | Anterior Cruciate Ligament (ACL) plays a crucial role in proper knee function and stability [Wii Fit™ is an exergaming video game released by Nintendo Wii™(Nintendo Co Ltd, Kyoto, Japan) with 48 exergames [The Nintendo Wii Balance Board (NWBB) is a unique accessory for the Wii console designed to train and also evaluat... | PMC10386671 |
Material and methods | bone-patellar tendon-bone | The study was designed as a pilot double-blinded randomized controlled trial carried out on 20 male athletes who underwent unilateral arthroscopic ACLR surgery with bone-patellar tendon-bone graft between March 2020 and March 2021. The Research Ethics Committee of Tarbiat Modares University approved the study (IR.MODAR... | PMC10386671 | |
Participants | knee ≤, traumatic injuries, lower extremity fractures, pain | DISEASES, NEUROMUSCULAR DISEASE | All participants were primarily checked for eligibility criteria before being referred to the physical therapy clinic. The inclusion criteria were as follows: (1) patient with ACLR surgery at least three months ago; (2) aged between 20 to 30 years; (3) BMI ≤ 30; (4) active ROM on reconstructed knee ≤ 90°; (5) normal me... | PMC10386671 |
Randomized allocation | Initially, 29 patients were enrolled to study; five of them did not fulfill the inclusion criteria. The eligible participants were 23 patients who were randomly allocated into two groups: (1) Nintendo Wii Fit system (named Wii group) as an intervention group, and their exercise program was given by a proposed ES. (2) T... | PMC10386671 | ||
Assessment procedures | Knee flexion, TG, knee effusion, pain | The patient underwent a baseline assessment including a demographic checklist, Visual Analog Scale (VAS) for pain, Knee flexion Range (KFR), Thigh Girth (TG), knee effusion, Balance Error Scoring System (BESS), Modified STAR Excursion Balance Test (MSEBT) and two functional tests of Single-Leg Hop for Distance (SLHD) a... | PMC10386671 | |
Proposed expert system | TG, knee effusion, effusion, Tightrope | EFFUSION | The proposed ES (Fig. The flowchart of the proposed ESThe main sources of knowledge for rehabilitation after ACLR were obtained from sports medicine and physiotherapist through several interviews, debates, and surveys of the Wii Fit exergames. According to the experts’ responses, the most important assessment variables... | PMC10386671 |
Interventions | pain | STRETCHES | All participants participated in 12 supervised 90-min exercise sessions; three times a week consisting of 15-min warm-up plus lower limb stretches, 60-min of an ES-based protocol based on the Wii Fit or conventional protocol, 15-min lower limb stretches, and a cool-down period. The patients had the same warm-up schedul... | PMC10386671 |
Statistical analysis | Statistical analyses were performed using SPSS version 25 (SPSS Inc., Chicago, IL, USA). The results were reported as mean ± Standard Deviation (SD) for quantitative variables and were summarized for categorical variables by frequency (percentage). Kolmogorov–Smirnov test was used to investigate the normal distribution... | PMC10386671 | ||
Discussion | ACL injuries, ACL, abnormal gait, muscle bulk atrophy, fibrosis, pain, muscular reflex, decreases its proprioceptive ability, knee effusion, effusion, TG | MUSCLE ATROPHY, FIBROSIS, NEUROMUSCULAR INHIBITION, JOINT EFFUSION, EFFUSION, COMPLICATIONS | Due to the growing number of people with ACL injuries and their urgent need for post-operative rehabilitation, numerous clinicians are seeking to develop new protocols to accelerate the rehabilitation process. With its board and exergames, Wii Fit could offer enjoyable training and accurate feedback to improve the outc... | PMC10386671 |
Limitations | Although our study investigated the effectiveness of ES-based Wii Fit protocols compared to conventional rehabilitation outcomes in patients following ACLR, it is important to acknowledge the limitations of our study. One such limitation is the small number of patients and the lack of follow-up due to the COVID-19 pand... | PMC10386671 | ||
Acknowledgements | The authors express their gratitude to the participants for their precious time, consent, and excellent cooperation. The authors gratefully acknowledge the valuable assistance of the academic members of Sports Medicine department; Iran University of Medical Sciences. | PMC10386671 | ||
Authors’ contributions | RECRUITMENT | AAb, AM, AK, and AAs conceived and designed the study. AAb and AM designed the expert system. AAb and AAs developed the expert system. AM assisted with the recruitment of participants. AAb and AM evaluated the patients and performed the rehabilitation programs. AAb and AK conducted the statistical analysis and interpre... | PMC10386671 | |
Funding | No funding to declare. | PMC10386671 | ||
Availability of data and materials | All data relevant to the study are included in the article. The datasets generated during and/or analyzed during the current study are available from the corresponding author, Arezoo Abasi, upon reasonable request. Please contact Arezoo Abasi at arezoo_abasi@modares.ac.ir for data requests. The data will be provided in... | PMC10386671 | ||
Declarations | PMC10386671 | |||
Ethics approval and consent to participate | The Research Ethics Committee of Tarbiat Modares University approved the study (IR.MODARES.REC.1398.124) and all patients provided written informed consent. The study was carried out based on the latest version of the Declaration of Helsinki. Our study was also approved as a Pilot controlled trial study in the Iranian ... | PMC10386671 | ||
Consent for publication | Not applicable. | PMC10386671 | ||
Competing interests | The authors declare no competing interests. | PMC10386671 | ||
References | PMC10386671 | |||
Abstract | PMC10154847 | |||
Introduction | Pharmacists are one of the most accessible health professionals in the United States, who, with training, may serve as gatekeepers who recognize suicide warning signs and refer at‐risk individuals to care. Our objective was to codesign a 30‐min online gatekeeper training module (Pharm‐SAVES) specifically for community ... | PMC10154847 | ||
Methods | Over a period of 8 months, a nine‐member pharmacy staff stakeholder panel and the Finger Lakes (New York) Veterans Research Engagement Review Board each worked with the study team to codesign Pharm‐SAVES. Formative data from previous interviews with community pharmacists were presented to the panels and guided website ... | PMC10154847 | ||
Results | Four key topics were identified for brief skills‐based modules that could be delivered asynchronously online. To help pharmacy staff understand their opportunities as gatekeepers in suicide prevention, statistics and statements from the Joint Commission and pharmacy professional organizations were highlighted in Module... | PMC10154847 | ||
Conclusion | communication behaviors | Pharm‐SAVES is a brief, online suicide prevention gatekeeper training program codesigned by researchers, community pharmacy and veteran stakeholders. By actively engaging stakeholders at each stage of the design process, we were able to create training content that was not only realistic but more relevant to the needs ... | PMC10154847 | |
Patient or Public Contribution | Stakeholder engagement was purposefully structured to engage pharmacy staff and pharmacy consumers, with multiple opportunities for study contribution. Likewise, the involvement of patient/public contribution was paramount in study design and overall development of our study team.
| PMC10154847 | ||
INTRODUCTION | Suicide is a persistent public health problem in the United StatesPharmacists are one of the most accessible health professionals in the United StatesTherefore, our objective was to work with stakeholders to codesign a 30‐min online training module specifically for community pharmacy staff. A codesign approach to resea... | PMC10154847 | ||
METHODS | A codesign approach was used to develop the suicide prevention training module. Vechakul and colleagues define codesign as a cooperative process bringing people and design professionals together to find new and innovative solutions for different problems of everyday life, this can include the innovation of technologica... | PMC10154847 | ||
RESULTS | buy‐in’, overdose, ’ | ABUSE | Twelve meetings occurred over the course of 8 months, during which there were nine meetings with an average of nine pharmacy stakeholders, two separate meetings with a veteran stakeholder (VREB) panel, and one separate meeting with two suicide prevention experts. Each meeting lasted roughly 1 h and was facilitated by t... | PMC10154847 |
DISCUSSION | Codesign approaches that directly involve stakeholders, have previously been shown to enhance the development and implementation of health interventions to improve patient outcomes across healthcare settings. | PMC10154847 | ||
Strengths and limitations | communication behaviors | There were several strengths in taking a codesign approach for the development of suicide prevention training for pharmacy staff. One such strength was that a codesign approach helped provide a framework in which feedback from one session guided and informed future meetings. Although a general meeting schedule and broa... | PMC10154847 | |
CONCLUSIONS | Pharm‐SAVES is a brief, online suicide prevention gatekeeper training program for community pharmacy staff who were integral to its development. The module incorporates written, video, and interactive content to maximize the participant's learning experience. By engaging with stakeholders to compose this content, pharm... | PMC10154847 | ||
AUTHOR CONTRIBUTIONS | PMC10154847 | |||
CONFLICT OF INTEREST STATEMENT | The authors declare no conflict of interest. | PMC10154847 | ||
ACKNOWLEDGEMENTS | CARPENTER | This project was supported by grant SRG‐0‐200‐17 award to Dr. Delesha Carpenter and Dr. Jill Lavigne by the American Foundation for Suicide Prevention. | PMC10154847 | |
DATA AVAILABILITY STATEMENT | Data are available on request from the authors. | PMC10154847 | ||
REFERENCES | PMC10154847 | |||
Abstract | F. Tanser and T. Bärnighausen are both senior authors. | PMC10440100 | ||
Introduction | While it is widely acknowledged that family relationships can influence health outcomes, their impact on the uptake of individual health interventions is unclear. In this study, we quantified how the efficacy of a randomized health intervention is shaped by its pattern of distribution in the family network. | PMC10440100 | ||
Methods | The “Home‐Based Intervention to Test and Start” (HITS) was a 2×2 factorial community‐randomized controlled trial in Umkhanyakude, KwaZulu‐Natal, South Africa, embedded in the Africa Health Research Institute's population‐based demographic and HIV surveillance platform (ClinicalTrials.gov # NCT03757104).The study invest... | PMC10440100 | ||
Results | Overall, 15,675 people participated in the HITS trial. Among those with no family members who received the offer, the incentive's efficacy was a 6.5 percentage point increase (95% CI: 5.3−7.7). The efficacy was higher among those with at least one family member who received the offer (21.1 percentage point increase (95... | PMC10440100 | ||
Conclusions | Micro‐incentives appear to have synergistic effects when distributed within family networks. These effects support family network‐based approaches for the design of health interventions. | PMC10440100 | ||
INTRODUCTION | Though family relationships crucially determine health and wellbeing, their role in shaping the uptake of individual health interventions is not well‐understood. Using family network data from a large population‐based cohort, we quantified the degree to which the efficacy of a randomized individual‐level health interve... | PMC10440100 | ||
METHODS | PMC10440100 | |||
Setting and participants | HITS is a community‐randomized controlled trial in the Hlabisa sub‐district of the uMkhanyakude district—a rural region of northern KwaZulu‐Natal with a high HIV burden and unemployment [Individuals were eligible for HITS if they were 15 years or older at the time of the surveillance visit, resided within the surveilla... | PMC10440100 | ||
Randomization and masking | The HITS study investigated two interventions: a financial micro‐incentive for HIV testing and a male‐targeted HIV‐specific decision support programme [Flow diagram for HITS trial.The 45 communities were grouped into four strata based on baseline HIV incidence rates among women aged 15–30 years. The intervention arm co... | PMC10440100 | ||
Consent and intervention | Only residents who agreed to participate in annual AHRI HIV surveillance were eligible to participate in HITS. Residents were asked for their consent at the study visit. Those who consented to AHRI HIV surveillance were then asked for their consent to participate in the HITS study.Those who were eligible for and consen... | PMC10440100 | ||
Social network | A socio‐centric family network was constructed among HITS‐eligible individuals using routinely collected surveillance data. Nodes in this network represent individuals. Three kinds of ties were added between the nodes: first‐degree relatives (parents, children and all conjugal partners of each participant), second‐degr... | PMC10440100 | ||
Measures | The outcome of interest was individual uptake of rapid HIV testing at the study visit. Exposures of interest were individual offer of financial incentive (“individual offer”) and family offer of incentive (“family offer”). For each participant, family offer was defined as the count of family members who were offered th... | PMC10440100 | ||
Analysis | REGRESSION, SECONDARY | We calculated sample characteristics, examined patterns of network connections between communities and described the composition of network connections.For the primary analysis, we examined heterogeneity in the effect of the individual offer on HIV testing uptake across strata defined by the dichotomized family offer (... | PMC10440100 | |
Missing data | REGRESSION | We conducted a complete case analysis as only 10/15,675 observations had missing outcome data. All other variables included in the regression models were complete. | PMC10440100 | |
Power and sample size | The HITS sample size was calculated to detect a relative reduction of 25% or more in HIV incidence among women aged 15–30 with power exceeding 80% and α = 0.05. Further details have been previously reported [ | PMC10440100 | ||
Ethics statement | The Biomedical Research Ethics Committee of the University of KwaZulu‐Natal approved study protocols for the AHRI's population‐based HIV testing platform and HITS intervention (BE290/16 and BFC398/16) [ | PMC10440100 | ||
RESULTS | PMC10440100 | |||
Participants and network | Two‐thirds | Of 37,068 residents who met the inclusion criteria for the HITS study, 15,675 participated and 15,665 were included in the analysis (see Figure It was common for participants to have family members in different households (60.4%, 9468/15,675) and different communities (42.2%, 6613/15,675) (see Table Baseline characteri... | PMC10440100 | |
Primary analysis | SECONDARY | We found support for the hypothesis that the effect of the incentive on an individual's HIV testing uptake is augmented by offering incentives to their family members prior to, or at the same time as, them (see Figure Effect heterogeneity of HITS intervention. The table shows results from the primary analysis (dichotom... | PMC10440100 | |
Secondary analysis | The strength of the effect of the individual offer increased as more family members received a prior or contemporaneous offer of the incentive, further supporting the main hypothesis. Effect sizes increased from 6.5% (95% CI: 5.3–7.7) among participants with no family members who received the offer to 26.3% (95% CI: 23... | PMC10440100 | ||
Sensitivity analysis | In the Supplementary Note, we examined the potential impact of selection bias in study participation on the results of the primary analysis. Figure | PMC10440100 | ||
DISCUSSION | The HITS study confirms that a modest community‐wide financial incentive increases the uptake of HIV testing. Our study establishes that an individual offered a financial incentive is more likely to take up testing when family members have received the same offer prior to or at the same time as them. The strength of th... | PMC10440100 | ||
CONCLUSIONS | By combining family network data with data from a field experiment, we showed that network‐based financial incentive programmes for a behavioural health intervention might be more efficient than individual‐based programmes. While the field experiment was conducted in 2018, it is likely that our findings continue to app... | PMC10440100 | ||
Role of the funding source | Study sponsors had no role in the design, data collection, analysis, interpretation or write‐up of this study, nor did they influence the decisions to submit the results for publication. | PMC10440100 | ||
COMPETING INTERESTS | The authors declare no competing interests relating to this manuscript. | PMC10440100 | ||
AUTHORS’ CONTRIBUTIONS | TB | KM conducted an analysis and drafted the manuscript. ETT, MTB and LB edited the manuscript. KM developed an analytic plan with ETT, HYK and TB. FT and TB accessed and verified all underlying data. All authors discussed and reviewed the manuscript. | PMC10440100 | |
Supporting information |
Click here for additional data file. | PMC10440100 | ||
ACKNOWLEDGEMENTS | Our sincere thanks to the Africa Health Research Institute's population‐based demographic and HIV surveillance platform. We are grateful, also, to peer reviewers and editors whose thoughtful criticism led to improvements in the manuscript. | PMC10440100 | ||
DATA AVAILABILITY STATEMENT | Study data, including de‐identified participant data and data dictionaries, are available for download from the AHRI Data Repository ( | PMC10440100 | ||
REFERENCES | PMC10440100 | |||
Abstract | active idiopathic intracranial hypertension | PAPILLOEDEMA, IDIOPATHIC INTRACRANIAL HYPERTENSION, MITCHELL, PRESSURE AREA | Therapeutics to reduce intracranial pressure are an unmet need. Preclinical data have demonstrated a novel strategy to lower intracranial pressure using glucagon-like peptide-1 (GLP-1) receptor signalling.Here, we translate these findings into patients by conducting a randomized, placebo-controlled, double-blind trial ... | PMC10151178 |
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