TY - JOUR
T1 - Adapting the Diabetes Prevention Program for low and middle-income countries
T2 - Protocol for a cluster randomised trial to evaluate 'Lifestyle Africa'
AU - Catley, Delwyn
AU - Puoane, Thandi
AU - Tsolekile, Lungiswa
AU - Resnicow, Ken
AU - Fleming, Kandace
AU - Hurley, Emily A.
AU - Smyth, Joshua M.
AU - Vitolins, Mara Z.
AU - Lambert, Estelle V.
AU - Levitt, Naomi
AU - Goggin, Kathy
N1 - Funding Information:
This work was supported by National Heart Lung and Blood Institute of the National Institutes of Health under award number R01HL126099.*%blankline%*
Funding Information:
The growing burden of NCDs in low and middle-income countries presents a critical need for evidence-based interventions that address behavioural contributors to the prevention and management of CVD and DM. Our study aims to adapt one of the strongest existing evidence-based lifestyle behaviour change interventions to the context of low-income, under-resourced urban areas of sub-Saharan Africa and rigorously assesses its impact in a cluster RCT. Results will inform both the feasibility and the effectiveness of an intervention delivery model that uses CHWs as facilitators, video as the primary medium for delivering content and enhancement of the DPP with Motivational Interviewing principles and a text message system. This will be an important addition to similar efforts that have targeted more educated and resourced populations in India. 54 Successful outcomes will hinge on both successful programme delivery as well as participant engagement and retention. The main outcomes will therefore need to be interpreted in the context of key aspects of study implementation including the success of training CHWs, the reliability and fidelity with which sessions are delivered and the engagement of participants. On completion of the study, a process evaluation is planned to enhance understanding of the outcomes by assessing CHW and participant perspectives on the strengths and weaknesses of the programme. Through training and technical support, the project also aims to build capacity in partner NGOs to continue the programme after the study has been completed. Strengths of the study include its community-engaged development process that has led to an intervention design that fits with the existing models of care of our partner NGOs and may be transferable to programme aimed at other NCDs. The study’s pragmatic design, including broad inclusion criteria, should also lead to findings that are relevant and generalisable to many communities in low and middle-income countries. Although the study is pragmatic and the result of a community-engaged process, it uses a rigorous cluster randomised design with objective measurements of key biometric and biologic outcomes related to diabetes and CVD. Chief among the challenges of the trial will be to achieve adequate reliability and fidelity in the delivery of the intervention in the context of an impoverished environment where resources are limited, residents are taxed trying to meet their basic needs and social disruptions (eg, strikes, protests, crime) are frequent. Limitations include low precision of measures like dietary and physical activity recalls as well as limitations of measure breadth due to low literacy. Regardless of the efficacy findings of the study, results should provide an important first step in understanding how lifestyle interventions such as the DPP might be disseminated in similar communities with few resources and low levels of education and literacy. Studies evaluating lifestyle behaviour change interventions in low and middle-income countries are vital for addressing the epidemic of diabetes and CVD. The authors acknowledge the contributions made by our Community Advisory Board in designing this study. Contributors All authors made substantial contributions to the design of the study. DC led the study design, with other authors collaborating on the design of specific aspects (TP/LT/KR/MZV/EVL/NSL—DPP intervention content; EAH/KR/KG/TP/LT—measures and outcomes; JMS—text message component; KR/KG—Motivational Interviewing content). KF contributed to the research design and led the development of the statistical analysis plan. DC and EAH drafted the manuscript and all others contributed to revising it critically for important intellectual content. All authors reviewed and approved of the final version submitted for publication and agree to be accountable for all aspects of the work in ensuing that questions related to accuracy and integrity are appropriately investigated and resolved. Funding This work was supported by National Heart Lung and Blood Institute of the National Institutes of Health under award number R01HL126099. Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. Competing interests None declared. Patient consent for publication Not required. Ethics approval Our study protocol has been approved by the IRBs at the University of Cape Town (the primary IRB) and Children’s Mercy Kansas City and the University of the Western Cape. Provenance and peer review Not commissioned; externally peer reviewed. Data availability statement Data are available upon reasonable request.
Publisher Copyright:
© 2019 Author(s).
PY - 2019/11/1
Y1 - 2019/11/1
N2 - Introduction Low 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/analysis The 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/m 2) 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/dissemination Ethical 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.
AB - Introduction Low 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/analysis The 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/m 2) 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/dissemination Ethical 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.
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U2 - 10.1136/bmjopen-2019-031400
DO - 10.1136/bmjopen-2019-031400
M3 - Article
C2 - 31719084
AN - SCOPUS:85074908082
SN - 2044-6055
VL - 9
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e031400
ER -