Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’

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...

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Main Authors: Thandi Puoane, Ken Resnicow, Naomi Levitt, Estelle V Lambert, Joshua M Smyth, Delwyn Catley, Lungiswa Tsolekile, Kandace Fleming, Emily A Hurley, Mara Z Vitolins, Kathy Goggin
Format: Article
Language:English
Published: BMJ Publishing Group 2019-11-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/9/11/e031400.full
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author Thandi Puoane
Ken Resnicow
Naomi Levitt
Estelle V Lambert
Joshua M Smyth
Delwyn Catley
Lungiswa Tsolekile
Kandace Fleming
Emily A Hurley
Mara Z Vitolins
Kathy Goggin
author_facet Thandi Puoane
Ken Resnicow
Naomi Levitt
Estelle V Lambert
Joshua M Smyth
Delwyn Catley
Lungiswa Tsolekile
Kandace Fleming
Emily A Hurley
Mara Z Vitolins
Kathy Goggin
author_sort Thandi Puoane
collection DOAJ
description 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/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/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.Trial registration number NCT03342274.
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spelling doaj-art-d41a230b33a94e84b7e533c98a95a3ab2024-11-27T15:20:08ZengBMJ Publishing GroupBMJ Open2044-60552019-11-0191110.1136/bmjopen-2019-031400Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’Thandi Puoane0Ken Resnicow1Naomi Levitt2Estelle V Lambert3Joshua M Smyth4Delwyn Catley5Lungiswa Tsolekile6Kandace Fleming7Emily A Hurley8Mara Z Vitolins9Kathy Goggin10Department of Women’s and Children’s Health, Uppsala University, Uppsala, Sweden1 Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, Michigan, USAChronic Diseases Initiative for Africa, University of Cape Town, Cape Town, South AfricaDivision of Exercise Science and Sports Medicine, University of Cape Town, Rondebosch, South AfricaBiobehavioral Health and Medicine, Penn State University Park, University Park, Pennsylvania, USACenter for Children`s Healthy Lifestyles and Nutrition, Children`s Mercy Hospitals and Clinics, Kansas City, Missouri, USASchool of Public Health, University of the Western Cape, Bellville, Western Cape, South AfricaLife Span Institute, University of Kansas, Lawrence, Kansas, USADepartment of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USADepartment of Epidemiology and Prevention, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USADepartment of Pediatrics, University of Missouri Kansas City School of Medicine, Kansas City, Missouri, USAIntroduction 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/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/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.Trial registration number NCT03342274.https://bmjopen.bmj.com/content/9/11/e031400.full
spellingShingle Thandi Puoane
Ken Resnicow
Naomi Levitt
Estelle V Lambert
Joshua M Smyth
Delwyn Catley
Lungiswa Tsolekile
Kandace Fleming
Emily A Hurley
Mara Z Vitolins
Kathy Goggin
Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’
BMJ Open
title Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’
title_full Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’
title_fullStr Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’
title_full_unstemmed Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’
title_short Adapting the Diabetes Prevention Program for low and middle-income countries: protocol for a cluster randomised trial to evaluate ‘Lifestyle Africa’
title_sort adapting the diabetes prevention program for low and middle income countries protocol for a cluster randomised trial to evaluate lifestyle africa
url https://bmjopen.bmj.com/content/9/11/e031400.full
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