Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa.
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SUBMITTER: Catley D
PROVIDER: S-EPMC9053793 | biostudies-literature | 2022 Apr
REPOSITORIES: biostudies-literature
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Evaluation of an adapted version of the Diabetes Prevention Program for low- and middle-income countries: A cluster randomized trial to evaluate "Lifestyle Africa" in South Africa.
Catley Delwyn D Puoane Thandi T Tsolekile Lungiswa L Resnicow Ken K Fleming Kandace K KK Hurley Emily A EA Smyth Joshua M JM Materia Frank T FT Lambert Estelle V EV Vitolins Mara Z MZ Levitt Naomi S NS Goggin Kathy K
PLoS medicine 20220415 4
<h4>Background</h4>Low- and middle-income countries (LMICs) are experiencing major increases in diabetes and cardiovascular conditions linked to overweight and obesity. Lifestyle interventions such as the United States National Diabetes Prevention Program (DPP) developed in high-income countries require adaptation and cultural tailoring for LMICs. The objective of this study was to evaluate the efficacy of "Lifestyle Africa," an adapted version of the DPP tailored for an underresourced community ...[more]
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Project description:IntroductionLow and middle-income countries like South Africa are experiencing major increases in burden of non-communicable diseases such as diabetes and cardiovascular conditions. However, evidence-based interventions to address behavioural factors related to these diseases are lacking. Our study aims to adapt the CDC's National Diabetes Prevention Program (DPP) within the context of an under-resourced urban community in Cape Town, South Africa.Methods/analysisThe new intervention (Lifestyle Africa) consists of 17 weekly sessions delivered by trained community health workers (CHWs). In addition to educational and cultural adaptations of DPP content, the programme adds novel components of text messaging and CHW training in Motivational Interviewing. We will recruit overweight and obese participants (body mass index ≥25 kg/m2) who are members of 28 existing community health clubs served by CHWs. In a 2-year cluster randomised control trial, clubs will be randomly allocated to receive the intervention or usual care. After year 1, usual care participants will also receive the intervention and both groups will be followed for another year. The primary outcome analysis will compare percentage of baseline weight loss at year 1. Secondary outcomes will include diabetes and cardiovascular risk indicators (blood pressure, haemoglobin A1C, lipids), changes in self-reported medication use, diet (fat and fruit and vegetable intake), physical activity and health-related quality of life. We will also assess potential psychosocial mediators/moderators as well as cost-effectiveness of the programme.Ethics/disseminationEthical approval was obtained from the University of Cape Town and Children's Mercy. Results will be submitted for publication in peer-reviewed journals and training curricula will be disseminated to local stakeholders.Trial registration numberNCT03342274.
| S-EPMC6858109 | biostudies-literature
Project description:BackgroundThe heavy and ever rising burden of non-communicable diseases (NCDs) in low- and middle-income countries (LMICs) warrants interventions to reduce their underlying risk factors, which are often linked to lifestyles. To effectively supplement nationwide policies with targeted interventions, it is important to know how these risk factors are distributed across socioeconomic segments of populations in LMICs. This study quantifies the prevalence and socioeconomic inequalities in lifestyle risk factors in LMICs, to identify policy priorities conducive to the Sustainable Development Goal of a one third reduction in deaths from NCDs by 2030.MethodsData from 1,278,624 adult respondents to Demographic & Health Surveys across 22 LMICs between 2013 and 2018 are used to estimate crude prevalence rates and socioeconomic inequalities in tobacco use, overweight, harmful alcohol use and the clustering of these three in a household. Inequalities are measured by a concentration index and correlated with the percentage of GDP spent on health. We estimate a multilevel model to examine associations of individual characteristics with the different lifestyle risk factors.ResultsThe prevalence of tobacco use among men ranges from 59.6% (Armenia) to 6.6% (Nigeria). The highest level of overweight among women is 83.7% (Egypt) while this is less than 12% in Burundi, Chad and Timor-Leste. 82.5% of women in Burundi report that their partner is "often or sometimes drunk" compared to 1.3% in Gambia. Tobacco use is concentrated among the poor, except for the low share of men smoking in Nigeria. Overweight, however, is concentrated among the better off, especially in Tanzania and Zimbabwe (Erreygers Index (EI) 0.227 and 0.232). Harmful alcohol use is more concentrated among the better off in Nigeria (EI 0.127), while Chad, Rwanda and Togo show an unequal pro-poor distribution (EI respectively - 0.147, - 0.210, - 0.266). Cambodia exhibits the largest socioeconomic inequality in unhealthy household behaviour (EI - 0.253). The multilevel analyses confirm that in LMICs, tobacco and alcohol use are largely concentrated among the poor, while overweight is concentrated among the better-off. The associations between the share of GDP spent on health and the socioeconomical distribution of lifestyle factors are multidirectional.ConclusionsThis study emphasizes the importance of lifestyle risk factors in LMICs and the socioeconomic variation therein. Given the different socioeconomic patterns in lifestyle risk factors - overweight patters in LMICs differ considerably from those in high income countries- tailored interventions towards specific high-risk populations are warranted to supplement nationwide policies.
| S-EPMC8134821 | biostudies-literature
Project description:To review the current literature around the potential impact, effectiveness and perceptions of plain packaging in low income settings.A systematic review of the literature.9 databases (PubMed, Global Health, Social Policy and Practice, Applied Social Sciences Index and Abstracts (ASSIA), CINAHL, PsycINFO, British Library for Development Studies (BLDS), Global Health Library and Scopus) were searched. The terms used for searching combined terms for smoking and tobacco use with terms for plain packaging.Studies investigating the impact of plain packaging on the determinants of tobacco use, such as smoking behaviour, appeal, prominence, effectiveness of health warnings, response to plain packs, attitudes towards quitting or likelihood of smoking in low-income settings, were identified. Studies must have been published in English and be original research of any level of rigour.Two independent reviewers assessed studies for inclusion and extracted data.The results were synthesised qualitatively, with themes grouped under four key headings: appeal and attractiveness; salience of health warnings and perceptions of harm; enjoyment and perceived taste ratings; and perceptions of the impact on tobacco usage behaviour.This review has identified four articles that met the inclusion criteria. Studies identified that tobacco products in plain packaging had less appeal than in branded packaging in low-income settings.This review indicates that plain packaging appears to be successful in reducing appeal of smoking and packets, and supports the call for plain packaging to be widely implemented in conjunction with other tobacco control policies. However, there are considerable gaps in the amount of research conducted outside high-income countries.
| S-EPMC4809104 | biostudies-other
Project description:AIM:To conduct advanced psychometric analysis of Primary Care Assessment Tool (PCAT) in Tibet and identify avenues for metric performance improvement. BACKGROUND:Measuring progress toward high-performing primary health care can contribute to the achievement of sustainable development goals. The adult version of PCAT is an instrument for measuring patient experience, with key elements of primary care. It has been extensively used and validated internationally. However, only little information is available regarding its psychometric properties obtained based on advanced analysis. METHODS:We used data collected from 1386 primary care users in two prefectures in Tibet. First, iterative confirmatory factor analysis examined the fit of the primary care construct in the original tool. Then item response theory analysis evaluated how well the questions and individual response options perform at different levels of patient experience. Finally, multiple logistic regression modeling examined the predicative validity of primary care domains against patient satisfaction. FINDINGS:A best final structure for the PCAT-Tibetan includes 7 domains and 27 items. Confirmatory factor analysis suggests good fit for a unidimensional model for items within each domain but doesn't support a unidimensional model for the entire instrument with all domains. Non-parametric and parametric item response theory analysis models show that for most items, the favorable response option (4 = definitely) is overwhelmingly endorsed, the discriminability parameter is over 1, and the difficulty parameters are all negative, suggesting that the items are most sensitive and specific for patients with poor primary care experience. Ongoing care is the strongest predictor of patient satisfaction. These findings suggest the need for some principles in adapting the tool to different health system contexts, more items measuring excellent primary care experience, and update of the four-point response options.
| S-EPMC6609993 | biostudies-literature
Project description:BackgroundType 2 diabetes is increasing globally, with the highest burden in low- to middle-income countries (LMICs) such as the Philippines. Developing effective interventions could improve detection, prevention, and treatment of diabetes. The Cardiovascular Health Awareness Program (CHAP), an evidence-based Canadian intervention, may be an appropriate model for LMICs due to its low cost, ease of implementation, and focus on health promotion and disease prevention. The primary aim of this study is to adapt the CHAP model to a Philippine context as the Community Health Assessment Program in the Philippines (CHAP-P) and evaluate the effect of CHAP-P on glycated hemoglobin (HbA1c) compared to a random sample of community residents in control communities.MethodsSix-month, 26-community (13 intervention, 13 control) parallel cluster randomized controlled trial in Zamboanga Peninsula, an Administrative Region in the southern Philippines. Criteria for community selection include: adequate political stability, connection with local champions, travel feasibility, and refrigerated space for materials. The community-based intervention, CHAP-P sessions, are volunteer-led group sessions with chronic condition assessment, blood pressure monitoring, and health education. Three participant groups will be involved: 1) Random sample of community participants aged 40 or older, 100 per community (1300 control, 1300 intervention participants total); 2) Community members aged 40 years or older who attended at least one CHAP-P session; 3) Community health workers and staff facilitating sessions.Primary outcomemean difference in HbA1c at 6 months in intervention group individuals compared to control.Secondary outcomesmodifiable risk factors, health utilization and access (individual); diabetes detection and management (cluster). Evaluation also includes community process evaluation and cost-effectiveness analysis.DiscussionCHAP has been shown to be effective in a Canadian setting. Individual components of CHAP-P have been piloted locally and shown to be acceptable and feasible. This study will improve understanding of how best to adapt this model to an LMIC setting, in order to maximize prevention, detection, and management of diabetes. Results may inform policy and practice in the Philippines and have the potential to be applied to other LMICs.Trial registrationClinicalTrials.gov ( NCT03481335 ), registered March 29, 2018.
| S-EPMC6547510 | biostudies-literature
Project description:ObjectiveUltrasound is widely regarded as an important adjunct to antenatal care (ANC) to guide practice and reduce perinatal mortality. We assessed the impact of ANC ultrasound use at health centres in resource-limited countries.DesignCluster randomised trial.SettingClusters within five countries (Democratic Republic of Congo, Guatemala, Kenya, Pakistan, and Zambia) METHODS: Clusters were randomised to standard ANC or standard care plus two ultrasounds and referral for complications. The study trained providers in intervention clusters to perform basic obstetric ultrasounds.Main outcome measuresThe primary outcome was a composite of maternal mortality, maternal near-miss mortality, stillbirth, and neonatal mortality.ResultsDuring the 24-month trial, 28 intervention and 28 control clusters had 24 263 and 23 160 births, respectively; 78% in the intervention clusters received at least one study ultrasound; 60% received two. The prevalence of conditions noted including twins, placenta previa, and abnormal lie was within expected ranges. 9% were referred for an ultrasound-diagnosed condition, and 71% attended the referral. The ANC (RR 1.0 95% CI 1.00, 1.01) and hospital delivery rates for complicated pregnancies (RR 1.03 95% CI 0.89, 1.20) did not differ between intervention and control clusters nor did the composite outcome (RR 1.09 95% CI 0.97, 1.23) or its individual components.ConclusionsDespite availability of ultrasound at ANC in the intervention clusters, neither ANC nor hospital delivery for complicated pregnancies increased. The composite outcome and the individual components were not reduced.Tweetable abstractAntenatal care ultrasound did not improve a composite outcome that included maternal, fetal, and neonatal mortality.
| S-EPMC6390492 | biostudies-literature
Project description:To test the applicability of the Clavien-Dindo Classification (CDC) in an LMIC setting and to compare the prevalence and severity of complications in patients <60 and ≥60 years of age a retrospective medical records review is used.
| 2400292 | ecrin-mdr-crc
Project description:The prevalence of non-communicable diseases, such as diabetes and cardiovascular disease, is rising in low- and middle-income countries (LMICs). Health behavior change (HBC) interventions such as the widely used Diabetes Prevention Program (DPP) are effective at reducing chronic disease risk, but have not been adapted for LMICs. Leveraging mobile health (mHealth) technology such as text messaging (SMS) to enhance reach and participant engagement with these interventions has great promise, yet we lack evidence-informed approaches to guide the integration of SMS specifically to support HBC interventions in LMIC contexts. To address this gap, we integrated guidance from the mHealth literature with expertise and first-hand experience to establish specific development steps for building and implementing SMS systems to support HBC programming in LMICs. Specifically, we provide real-world examples of each development step by describing our experience in designing and delivering an SMS system to support a culturally-adapted DPP designed for delivery in South Africa. We outline eight key SMS development steps, including: 1) determining if SMS is appropriate; 2) developing system architecture and programming; 3) developing theory-based messages; 4) developing SMS technology; 5) addressing international SMS delivery; 6) testing; 7) system training and technical support; and 8) cost considerations. We discuss lessons learned and extractable principles that may be of use to other mHealth and HBC researchers working in similar LMIC contexts.Trial registration Clinicaltrials.gov, NCT03342274 . Registered 10 November 2017.
| S-EPMC10416414 | biostudies-literature
Project description:ObjectiveCluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time.DesignA systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews.Data sourcesWe searched MEDLINE between 1 January 2017 and 17 August 2022.Eligibility criteria for selecting studiesWe included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs and published in English between 2017 and 2022.Data extraction and synthesisData were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of the reports. Results were summarised overall and categorised by country's economic level or publication year.ResultsAmong 800 identified CRTs, 400 (50.0%) randomised geographical areas and 373 (46.6%) were conducted in Africa. 30 (3.7%) had no authors with an LMIC affiliation, and 246 (30.8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases as a country's economic level increases. Most CRTs focused on reducing maternal and neonatal disorders (106, 13.3%). 670 (83.8%) CRTs reported trial registration, 786 (98.2%) reported research ethics committee review and 757 (94.6%) reported consent statements. Among the 757 CRTs, 46 (6.1%) reported a waiver or no consent and, among these, 10 (21.7%) did not provide a rationale. Gatekeepers were identified in 403 (50.4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time.ConclusionOur findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed.
| S-EPMC11409340 | biostudies-literature
Project description:In recent decades low- and middle-income countries (LMICs) have been witnessing a significant shift toward raised blood pressure; yet in LMICs, only 1 in 3 are aware of their hypertension status, and ≈8% have their blood pressure controlled. This rising burden widens the inequality gap, contributes to massive economic hardships of patients and carers, and increases costs to the health system, facing challenges such as low physician-to-patient ratios and lack of access to medicines. Established risk factors include unhealthy diet (high salt and low fruit and vegetable intake), physical inactivity, tobacco and alcohol use, and obesity. Emerging risk factors include pollution (air, water, noise, and light), urbanization, and a loss of green space. Risk factors that require further in-depth research are low birth weight and social and commercial determinants of health. Global actions include the HEARTS technical package and the push for universal health care. Promising research efforts highlight that successful interventions are feasible in LMICs. These include creation of health-promoting environments by introducing salt-reduction policies and sugar and alcohol tax; implementing cost-effective screening and simplified treatment protocols to mitigate treatment inertia; pooled procurement of low-cost single-pill combination therapy to improve adherence; increasing access to telehealth and mHealth (mobile health); and training health care staff, including community health workers, to strengthen team-based care. As the blood pressure trajectory continues creeping upward in LMICs, contextual research on effective, safe, and cost-effective interventions is urgent. New emergent risk factors require novel solutions. Lowering blood pressure in LMICs requires urgent global political and scientific priority and action.
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