title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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3.2. The Effect of RIPC on Endothelial Function and Nitric Oxide Bioavailability | All 60 patients had a preoperative measurement of RHI. All but one patient had at least one follow-up measurement within 24 h after surgery. The reason for missing measurements of RHI in one patient was postoperative nausea (four hours after surgery) and early discharge (<24 h after surgery). Patients in our study had ... | PMC10047371 | ||
3.3. The Effect of Surgery on Endothelial Function and Nitric Oxide Bioavailability | RHI did not change significantly in response to surgery ( | PMC10047371 | ||
Author Contributions | Conceptualization, K.L.W., J.B., J.L., I.G. and S.E.; data curation, K.L.W.; formal analysis, K.L.W.; funding acquisition, K.L.W.; investigation, K.L.W., H.F.H. and M.K.; methodology, K.L.W., J.B., J.L., I.G. and S.E.; project administration, K.L.W., I.G. and S.E.; resources, J.L. and I.G.; supervision, J.L., I.G. and ... | PMC10047371 | ||
Institutional Review Board Statement | MAY | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by The Danish Data Protection Agency (no. REG-020-2019, 16 April 2019) and by the Regional Ethics Committee of Region Zealand Denmark (no. SJ-762, 7 May 2019). | PMC10047371 | |
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10047371 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC10047371 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10047371 | ||
References | hyperaemia | HYPERAEMIA | Patient selection flow chart.Endothelial function and markers of NO bioavailability stratified by remote ischemic preconditioning in patients undergoing surgery. Means and 95% CI of reactive hyperaemia index (RHI), L-arginine, asymmetric dimethylarginine (ADMA), L-arginine/ADMA-ratio, tetrahydrobiopterin (BHChanges of ... | PMC10047371 |
Objectives | To compare clinical, radiographic, biological and technical long-term outcomes of two types of dental implants over a period of 10 years. | PMC10713755 | ||
Materials and methods | Ninety-eight implants were placed in 64 patients | PMC10713755 | ||
Results | STM, peri-implantitis, peri-implant mucositis | COMPLICATIONS | Re-examination was performed in 43 patients (23 AST and 20 STM) at 10 years. The implant level analysis was based on 37 (AST) and 32 (STM) implants. Survival rates of 100% were obtained for both groups. The median changes of the marginal bone levels between baseline and TTechnical complications occurred in 27.0% of the... | PMC10713755 |
Conclusions | STM, peri-implant mucositis | COMPLICATIONS | Irrespective of the implant system used, the survival rates after 10 years were high. Minimal bone level changes were observed, statistically significant but clinically negligible in favor of STM. Technical complications were more frequently encountered in group AST, while group STM had a higher prevalence of peri-impl... | PMC10713755 |
Keywords | Open access funding provided by University of Zurich | PMC10713755 | ||
Introduction | COMPLICATIONS | Implant dentistry has substantially changed the way patients are treated with fixed and removable prosthetic solutions to reestablish chewing function and esthetics [These data indicate that the proposed success criteria are being complied up to the present time. Apart from the traditional measurement of marginal bone ... | PMC10713755 | |
Material and methods | PMC10713755 | |||
Study design | STM, dehiscence | DEHISCENCE, PLAQUE | The present randomized controlled clinical trial was approved by the local ethics committee (Kantonale Ethikkommission Kanton Zürich, Ref. Nr. KEK-ZH-Nr. 2013–0121) and was performed following the principles outlined in the World's Medical Association's Declaration of Helsinki on experimentation involving human subject... | PMC10713755 |
Outcome measures | PD, tooth | PLAQUE | Six sites per implant (mesiobuccal, buccal, distobuccal, distolingual, lingual and mesiolingual) and the neighboring teeth/implant(s) and contralateral tooth or implant sites were assessed for clinical measurements using a periodontal probe (UNC-15, Hu-Friedy, Chicago, IL, USA) at each follow-up appointment. All measur... | PMC10713755 |
Biological complications | bleeding, swelling, bone loss, Peri‐implant mucositis, erythema, peri-implantitis, peri-implant mucositis, periimplantitis | SUPPURATION, DISEASES, BLEEDING, BONE LOSS, ERYTHEMA, COMPLICATIONS | Peri‐implant mucositis and periimplantitis were defined according to the consensus report of the 2017 World Workshop on the Classification of Periodontal and Peri‐Implant Diseases and Conditions [The incidence of biological complications was assessed at the follow-up visits or in case patients came in for an extra visi... | PMC10713755 |
Technical complications | fracture | SCREW LOOSENING, COMPLICATIONS | The occurrence of technical complications was registered once per time-point for each implant. Technical complications encompassed: chippings, screw loosening and screw fracture, abutment fracture and the loss of the implant crown. | PMC10713755 |
Statistical analysis | Data were collected and added to a spreadsheet (Microsoft Excel, Microsoft Corporation, Redmond, Washington, USA). Statistical analysis was performed with a statistical analysis software (SAS 9.4, SAS Corp., Cary NC. USA). Descriptive summary statistics was obtained on the implant level as well on the patient level.On ... | PMC10713755 | ||
Results | PMC10713755 | |||
Survival rates | periimplantitis | During the 10-year follow-up, five implants were lost. In group AST, four implants in three patients were lost due to periimplantitis. In group STM, one implant was lost due to peri-implantitis. This amounts to a survival rate of 89.7% for group AST and 96.8% for group STM. On the patient level with one randomly select... | PMC10713755 | |
Technical and biological complications on the implant level | STM, peri-implant mucositis | COMPLICATIONS | Technical complications occurred in 10 out of 37 implants (27.0%) in group AST and in 5 out of 32 implants (15.6%) in group STM during 10 years (intergroup comparison: The prevalence of peri-implant mucositis was 29.7% in group AST (affecting 11 implants) and 50.1% in group STM (16 implants) at T | PMC10713755 |
Technical and biological complications on the patient level | STM, peri-implant mucositis | COMPLICATION, COMPLICATIONS | On the patient level, technical complications occurred in 5 out of 23 implants (21.7%) in group AST during 10 years. Within the last two years (8–10 years of follow-up), the technical complication rates were 8.7% (2 of 23 implants). None of the implants in group STM showed a technical complication (0.0%) in the last fo... | PMC10713755 |
Clinical outcome measures | STM, bleeding, PD | BLEEDING, PLAQUE | Clinical outcomes on patient level for both implant systems (AST and STM) at the time of loading (TL), and at the 10-year (TClinical outcomes on patient level for both implant systems (AST and STM) at the time of loading (TL), and at the 10-year (T10) follow-up examination with the respective changes over time. Patient... | PMC10713755 |
Discussion | STM, fractures, peri-implantitis, peri-implant mucositis | SCREW LOOSENING, COMPLICATION, COMPLICATIONS | The present long-term randomized controlled clinical trial comparing two types of dental implants with non-matching implant-abutment junctions supporting fixed restorations at 10 years of loading revealed: i) high survival rates for both types of dental implants, ii) stable marginal bone levels, iii) a higher rate of t... | PMC10713755 |
Author contribution | NG: performed the follow-ups, analyzed the data, major contribution to the manuscript.AI: analyzed the data, major contribution to finishing the study.NN: analyzed the data, major contribution to finishing the study.JH: analyzed the date, statistical analysis and contribution to finishing the manuscript.RJ: conceived t... | PMC10713755 | ||
Funding | Open access funding provided by University of Zurich The study was fully funded by the Clinic of Reconstructive Dentistry. | PMC10713755 | ||
Data Availability | All data supporting the present investigation is available upon request. | PMC10713755 | ||
Declarations | PMC10713755 | |||
Ethics approval and Consent to Participate | The study was approved by the local ethics committee (Kantonale Ethikkommission Kanton Zürich, Ref. Nr. KEK-ZH-Nr. 2013–0121) and was performed following the principles outlined in the World's Medical Association's Declaration of Helsinki on experimentation involving human subjects. The informed consent obtained from s... | PMC10713755 | ||
Conflict of interests | Dr. Jung received grants and personal fees from Institute Straumann AG and ITI, Dr. Thoma received personal fees and non-financial support from Straumann AG and grants, personal fees and non-financial support from Dentsply Sirona, Dr. Naenni reports grants and personal fees from ITI and grants from Dentsply Sirona, Dr.... | PMC10713755 | ||
References | PMC10713755 | |||
Abstract | PMC9847617 | |||
Objective | neuropsychiatric disorders, SUD | COMPLICATIONS, DISORDERS, METABOLIC DISORDERS | Patients with substance use disorders (SUD) under methadone maintenance therapy (MMT) are susceptible to a number of complications (psychological and metabolic disorders). Evidence studies have shown the roles of the glutamatergic system in addiction. N‐Acetylcysteine (NAC) enhances extracellular glutamate, and is effe... | PMC9847617 |
Methods | In the current randomized, double‐blind, placebo‐controlled clinical trial, outpatients with SUD under MMT who were 18–60 years old received 2400 mg/day NAC ( | PMC9847617 | ||
Results | depression | Compared with the placebo group, NAC treatment resulted in a significant improvement in depression score (β −2.36; 95% CI, −3.97, −0.76; | PMC9847617 | |
Conclusion | depression, anxiety | In the current study, improvement in depression and anxiety symptoms as well as some metabolic profiles with NAC treatment for 12 weeks in outpatients with SUD under MMT was detected.
Research Deputy of Kashan University of Medical Sciences (KAUMS/99029) | PMC9847617 | |
INTRODUCTION | OUD | DISORDER | Opioid use disorder (OUD) is a growing issue globally (Jayawardana et al., Pharmacologic treatment options for several SUD (e.g., opioids, stimulants, cannabis, alcohol, phencyclidine and other hallucinogens, inhalants, sedatives, anxiolytics, or hypnotics; tobacco and other or unknown substances) are limited. NAC is a... | PMC9847617 |
METHODS | PMC9847617 | |||
Trial design and setting | This was a 12‐week, randomized, double‐blind, placebo‐controlled, parallel‐group clinical trial of NAC in participants with SUD under MMT who were referred to a university‐affiliated outpatient SUD clinic (Soltan Mirahmad) in Kashan, Iran. The Soltan Mirahmad clinic is a center that is certified for the treatment and d... | PMC9847617 | ||
Inclusion/exclusion criteria | hypothyroidism | HYPERTHYROIDISM, HYPOTHYROIDISM, HYPERTENSION | Inclusion criteria: (1) SUD as diagnosed by DSM‐IV‐TR scales, (2) patients who received MMT, and (3) patients who were between 18 and 60 years.Exclusion criteria: (1) taking of anti‐oxidant and anti‐inflammatory supplements during the last 3 months, (2) hypertension, (3) hypothyroidism and hyperthyroidism, (4) positive... | PMC9847617 |
Study design and participants | In this trial, participants were assigned to receive either NAC ( | PMC9847617 | ||
Safety reporting | ADVERSE EVENTS, ADVERSE EVENT, ADVERSE EFFECTS | Adverse events are defined as any undesirable experience occurring to patients during the trial, whether or not related to NAC. The patients were entirely justified about the side effects of NAC or for taking medication and placebo. All patients were requested to inform investigators about any complaints and adverse ev... | PMC9847617 | |
Randomization and blinding | Randomization was done using computer‐generated random numbers (Stat Trek software) by trained staff at the Soltan Mirahmad Clinic (Kashan, Iran). Allocation concealment was done using sequentially numbered, sealed, opaque packages. Both randomization and allocation were carried out by independent persons who were not ... | PMC9847617 | ||
Assessment of outcome | SECONDARY | Psychological status is an important indicator of the health status in patients with SUD under MMT. So, psychological status was considered as the primary outcome and metabolic biomarkers as the secondary outcome. | PMC9847617 | |
Psychological measures | depression, Depression | Beck's Depression Inventories (BDI) was used to assess the levels of depression. BDI was determined using a self‐compiled questionnaire of 21 items in multiple‐choice format (Beck et al., | PMC9847617 | |
Metabolic measures | BLOOD, INSULIN SENSITIVITY | At baseline and the end of the trial, 10 ml fasting blood was collected from each patient at the Kashan laboratory (Iran) in the early morning after an overnight fast. Blood was collected in two separate tubes: (1) one without EDTA to separate the serum to determine serum insulin, fasting plasma glucose (FPG), lipid pr... | PMC9847617 | |
Statistical analysis | PMC9847617 | |||
Sample size | We did not detect a similar trial about the effects of NAC on psychological status and metabolic biomarkers in patients with SUD under MMT for determining the sample size based on the primary outcome. Hence, the sample size was calculated based on the effects of oral NAC treatment on the status of inflammatory markers ... | PMC9847617 | ||
RESULTS | Out of 82 screened outpatients with SUD under MMT program, 60 individuals were enrolled in the clinical trial and randomly assigned to both treatment and control groups to receive NAC or placebo, respectively (30 individuals to each group). In the control group, seven people discontinued the clinical trial due to perso... | PMC9847617 | ||
Psychological status | depression, Depression, Anxiety | REGRESSION | Compared with the control group, NAC significantly reduced the score of depression level (β −2.36; 95% CI, −3.97, −0.76; Means (± SD) of psychological status at baseline and after the 12‐week intervention in outpatients with SUD under MMT
Abbreviations: BDI, Beck Depression Inventory; BAI, Beck Anxiety Inventory; PSQI,... | PMC9847617 |
Metabolic profiles | SD | REGRESSION, INSULIN SENSITIVITY | NAC significantly decreased HOMA‐IR (β −0.33; 95% CI, −0.65, −0.009; Means (± SD) of metabolic biomarkers at baseline and after the 12‐week intervention in outpatients with SUD under MMT
Abbreviations: FPG, fasting plasma glucose; GSH, total glutathione; HOMA‐IR, homeostasis model of assessment‐insulin resistance; HDL‐... | PMC9847617 |
DISCUSSION | DISORDER | Pharmacologic treatment options for many SUD are scarce. This is especially true for cannabis use and cocaine use disorder, for which there are not FDA‐approved (Tomko et al., | PMC9847617 | |
Effects of NAC on psychological status | depression, psychological impairments, anxiety | MMT programs may be correlated with psychological impairments such as poor general health, depression, and anxiety score (Peles et al., | PMC9847617 | |
Effects of NAC on metabolic profiles | pain | DISORDERS | Our study indicated that taking NAC for 12 weeks in outpatients with SUD under MMT resulted in a significant reduction in HOMA‐IR, hs‐CRP levels, and a significant increase in GSH and TAC levels; however, it did not influence other metabolic profiles. Methadone therapy is linked to some disorders, including enhanced in... | PMC9847617 |
CONCLUSION | depression, anxiety | INSULIN RESISTANCE | Overall, NAC consumption for 12 weeks had promising effects on mental health symptoms (depression and anxiety), insulin resistance, body anti‐oxidative defense system (TAC and GSH), and hs‐CRP levels in outpatients with SUD under MMT. | PMC9847617 |
AUTHOR CONTRIBUTIONS | Samira Abbaszadeh‐Mashkani | Fateme Padoei, Peyman Mamsharifi, Pooya Hazegh, Homa Boroumand, Fatemeh Ostadmohammady, Samira Abbaszadeh‐Mashkani, Hamid Reza Banafshe, Amir Hassan Matini, Somayeh Ghadami Dehkohneh, and Amir Ghaderi contributed to the conception, design, statistical analysis, and drafting of the manuscript. All authors approved the f... | PMC9847617 | |
CONFLICT OF INTEREST | The authors declare that they have no conflict of interest. | PMC9847617 | ||
PEER REVIEW | The peer review history for this article is available at | PMC9847617 | ||
ACKNOWLEDGMENTS | This study was the thesis of a general practitioner (Fateme Padoei). It has been registered with the | PMC9847617 | ||
DATA AVAILABILITY STATEMENT | The datasets generated and/or analyzed during the current study are not publicly available because the intellectual property is owned by the funding body. They may be available from the corresponding author on reasonable request containing the approval from the associated funding body. | PMC9847617 | ||
REFERENCES | PMC9847617 | |||
1. Introduction | CVDs, Cardiovascular diseases | CVD, ELEVATED CHOLESTEROL, CARDIOVASCULAR DISEASE | Emerging evidence suggests that PPARG gene polymorphisms may influence lipid metabolism and cardiovascular risk, with omega-3 fatty acids proposed to modulate these effects. This study aims to assess the effects of fish oil supplementation on cardiovascular markers among adults with PPARG gene polymorphisms in a random... | PMC10780403 |
2. Materials and Methods | This was a randomized, double-blind, parallel-group clinical trial that compared treatment with omega-3 fatty acids to placebo. The study protocol was approved by the local Ethics Committee and conducted in compliance with the protocol and in accordance with standard institutional operating procedures and the Declarati... | PMC10780403 | ||
2.1. Patient Population and Design | muscle diseases, cardiovascular disease | MUSCLE DISEASE, CARDIOVASCULAR DISEASE | Patients were eligible based on the following criteria:Inclusion criteria:Age between 40 and 75;LDL-C level between 70 and 190 mg/dL, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form.Exclusion criteria:Personal history of cardiovascular disease or high r... | PMC10780403 |
2.2. Study Endpoints | The primary endpoint was the percent change in LDL-C for omega-3 fatty acids compared with placebo among patients with PPARG polymorphism. Secondary endpoints included the percent change in hsCRP, high-density lipoprotein cholesterol (HDL-C), total cholesterol, and serum triglycerides between subgroups. | PMC10780403 | ||
2.3. Sample Size Calculation and Statistical Power | MINOR | For our randomized, placebo-controlled trial, the primary objective was to discern a 15% reduction in LDL-C levels in the omega-3 fatty acid group compared to the placebo group, with an anticipated average LDL-C level of 145 mg/dL. We considered a standard deviation of 15% in LDL-C level changes across both groups. The... | PMC10780403 | |
2.4. Statistical Analyses | The primary statistical analysis was centered on evaluating the efficacy of omega-3 fatty acids in reducing LDL-C levels compared to placebo. The analysis was conducted on an intention-to-treat basis, including all randomized patients who received at least one dose of the study medication and had at least one post-base... | PMC10780403 | ||
3. Results | ± | A total of 102 patients were subjected to randomization. Among these, 99 successfully completed both the baseline and follow-up laboratory evaluations, as depicted in The baseline characteristics of patients assigned to the omega-3 fatty acids and placebo groups displayed no significant differences in most parameters, ... | PMC10780403 | |
4. Discussion | LDL-C reduction, hyperlipidemia, diabetes mellitus, Diabetes mellitus, atherosclerotic, CAD, dyslipidemia, metabolic syndrome, diabetes | ELEVATED CHOLESTEROL, HYPERLIPIDEMIA, CARDIOVASCULAR DISEASES, CVD, DIABETES MELLITUS, DIABETES MELLITUS, HYPERGLYCEMIA, DIABETES, SECONDARY, INSULIN RESISTANCE, DYSLIPIDEMIA, ELEVATED GLUCOSE, METABOLIC SYNDROME, INSULIN SENSITIVITY, CAD, CORONARY ARTERY DISEASE | In the present study, we successfully replicated the interaction of genetic variants at PPARG with omega-3 fatty acids on blood lipids. The principal outcomes of this randomized, double-blind, parallel-group clinical trial include: (1) among patients with PPARG polymorphisms, elevated cholesterol levels, and low-to-mod... | PMC10780403 |
5. Conclusions | dyslipidemia | ELEVATED CHOLESTEROL, DYSLIPIDEMIA | Our study provides robust evidence supporting the modulatory role of PPARG polymorphisms in lipid metabolism in response to omega-3 fatty acid supplementation. The data obtained from this randomized, double-blind, parallel-group clinical trial unequivocally demonstrate that patients with PPARG polymorphisms, who are at... | PMC10780403 |
Author Contributions | Conceptualization, writing—review and editing, E.P.; methodology, writing—original draft preparation, A.P., S.B. and I.P.; formal analysis, C.G.; investigation, S.B., I.P., E.S. (Evgenya Shrainer), E.V., E.S. (Ekaterina Sokolova) and M.J.; data curation, R.M. All authors have read and agreed to the published version of... | PMC10780403 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Center for New Medical Technologies Ethics Committee (approval number 0172CS_2022, 10 February 2020). | PMC10780403 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10780403 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available as the participants did not consent to their data being shared publicly. | PMC10780403 | ||
Conflicts of Interest | Authors Evgeny Pokushalov, Michael Johnson, Claire Garcia and Richard Miller was employed by the company Scientific Research Laboratory, Triangel Scientific. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential c... | PMC10780403 | ||
References | Study Design and Patient Flow.Mean Percent LDL-C Change (% Change from Baseline (95% CI); independent Mean Percent Serum Triglycerides Change (% Change from Baseline (95% CI); independent Baseline population characteristics by genetic variants at PPARG (mean ± SD, Primary and Secondary Endpoints (independent | PMC10780403 | ||
Objective | T2DM | This study investigated the effectiveness of health information and the healthy plate model on cardio-metabolic risk factors, knowledge and attitude towards T2DM prevention measures. | PMC10650998 | |
Methods | T2DM | A pre-post analysis, as part of a cluster randomized trial with street food vendors and their customers, was implemented in three randomly selected districts in Dar es Salaam, Tanzania. Two vendor-customer clusters each with 15 and more vendors from each district were randomly assigned to receive either T2DM health inf... | PMC10650998 | |
Results | Overall, 336 (IP2 = 175 and IP1 = 161) out of 560 (280/arm) previous study participants participated in evaluation. Diastolic BP was lower among IP2 participants in the evaluation than baseline AβC = -4.1mmHg (95%CI:-5.42 to -2.76). After adjusting for the interaction between IP2 and age of the consumers, the BMI was s... | PMC10650998 | ||
Conclusion | The positive effects on cardio-metabolic risk factors, knowledge and attitude were observed in both intervention arms. Due to interactions between IP2, age and income; designing interventions relating to food and cardio-metabolic risk factors, should consider combining socio-economic factors. | PMC10650998 | ||
Data Availability | The National Health Research Ethics Committee (NatHREC) has developed a guideline that before data are taken outside Tanzania, clearance is sought to NatHREC by completing a Data Transfer Agreement (DTA) which is signed by both parties, provider and recipient of data stating the reason for transfer and which data are b... | PMC10650998 | ||
Introduction | T2DM | TYPE 2 DIABETES, DISEASES | In urban areas, a rising number of people consume meals outside their homes, most often unhealthy foods, i.e., food high in fat, sugar, and salt, hence increasing their risks for developing non-communicable diseases (NCDs) including type 2 diabetes [The current study involved implementation of two interventions namely:... | PMC10650998 |
Material and methods | PMC10650998 | |||
Study design and setting | This pre-post analysis as part of a cluster randomized trial study was implemented from April 2018 to September 2019 in three out of five randomly selected districts in Dar es Salaam city. The study setting has been previously described in detail in our baseline study [ | PMC10650998 | ||
Study population and sample size calculation | A street food consumer is defined as a person who buys, and eats food or drink prepared in the street or at a supplier’s home, which is then sold in the street/public areas [ | PMC10650998 | ||
Eligibility criteria for market site, street food consumers and vendors | A market site was eligible for the study if it had at least 15 street food vendors. Regular street food consumers: A consumer was eligible for the study if he/she met the following criteria: being aged 25–64 years; consuming at least three lunches per week at the same street food vendor; having no plans to move out of ... | PMC10650998 | ||
Allocation of study market sites/clusters | Three out of five districts included Kinondoni, Ubungo and Ilala, which were randomly selected from Dar es Salaam city. From each sampled district, the study mapped all markets sites (clusters) then two markets were selected from each district randomly. In each district, one cluster was randomly assigned to receive IP1... | PMC10650998 | ||
Recruitment of vendors and consumers | Street food vendors were mapped at each selected market site. From 152 food vendors in 6 selected markets (sites), 58 food vendors were randomly selected; Ilala (13), Ubungo (23) and Kinondoni (22). In each selected market, 90 regular street foods consumers were recruited with a minimum of 7 regular consumers per vendo... | PMC10650998 | ||
CONSORT chart showing the phases of a parallel cluster randomised trial of two groups include enrolment, intervention allocation, follow-up and data analysis. | RECRUITMENT | *Number of food consumers considered were the regular street food consumers i.e. those who consumed three or more lunches per week from the same food vendors; # stands for “number”.The recruitment of study participants including seeking consent took place from November 2018 to March 2019. The process involved awareness... | PMC10650998 | |
Intervention packages | PMC10650998 | |||
Intervention package 1 –IP1 (T2DM health information) | This study used the One Health approach [ | PMC10650998 | ||
Intervention package 2-IP2 (T2DM health information and healthy plate model) | T2DM | This package comprised two components, T2DM health information and a subsidized plate model, enabling vendors to sell subsidized meals following the plate model principles. The study adopted a plate model validated by nutrition experts from the Harvard School of Public Health [ | PMC10650998 | |
Implementation steps | T2DM | Implementation of this study involved four steps. In the first step, baseline data was collected to serve as control from August to September 2018. This phase involved collection of information of socio-economic and demographic characteristics, NCDs’ behavioural risks, cardio-metabolic risks, familial risks, knowledge ... | PMC10650998 | |
Study conceptual framework | The study summary concept is described in | PMC10650998 | ||
Conceptual framework showing connections between behavioural and metabolic risk factors and pathogenesis of Type2 diabetes and the role of interventions on causality; Modified from Roman-urrestarazu et al. and Budreviciute et al [ | PMC10650998 | |||
Study variables | PMC10650998 | |||
Dependent variables | T2DM | SECONDARY | In this study, the primary outcome was cardio metabolic risk factors (i.e., BMI, blood glucose, triglycerides, and waist circumference, systolic and diastolic BP). Correct knowledge on T2DM and positive attitude scores towards prevention measures of T2DM were the secondary outcomes of interest. All dependent variables ... | PMC10650998 |
Independent variables | The independent variables include age, sex, marital status, income, education level and exposer status to intervention (baseline and IP1 or IP2); these were considered as fixed independent variables. The two random effects included were market sites and participant identification numbers. | PMC10650998 |
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