Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program

BMC Public Health

Study Protocol

Paul Zimmet¹  Paula Lorgelly²  Edwin Fisher³  Bruce Hollingsworth⁴  Emily D Williams⁵  Robyn Tapp⁶  Damien Jolley⁷  Ajay Mahal⁷  Thirunavukkarasu Sathish⁷  Naanki Pasricha⁷  Zahra Aziz⁷  Brian Oldenburg⁷  Rory Wolfe⁷  Jonathan Shaw⁸  Elezebeth Mathews⁹  Kavumpurathu Raman Thankappan⁹  Meena Daivadanam^1,10  Pilvikki Absetz^1,11 

[1] Baker IDI Heart and Diabetes Institute, Melbourne, Australia;Centre for Health Economics, Monash University, Melbourne, Australia;Department of Health Behavior, Gillings School of Global Public Health, Peers for Progress, American Academy of Family Physicians Foundation, University of North Carolina, Chapel Hill, USA;Division of Health Research, Lancaster University, Lancaster, UK;National Heart and Lung Institute, Imperial College London, London, UK;Optometry and Vision Sciences, University of Melbourne, Melbourne, Australia;School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia;School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia;Baker IDI Heart and Diabetes Institute, Melbourne, Australia;Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India;Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India;Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden;University of Tampere, Tampere, Finland;

关键词: Diabetes;    Incidence;    India;    Kerala;    Peer support;    Randomised controlled trial;    Prevention;    Resource-constrained settings;    Rural;    Intervention;   

DOI  :  10.1186/1471-2458-13-1035

 received in 2013-10-19, accepted in 2013-10-25,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundIndia currently has more than 60 million people with Type 2 Diabetes Mellitus (T2DM) and this is predicted to increase by nearly two-thirds by 2030. While management of those with T2DM is important, preventing or delaying the onset of the disease, especially in those individuals at ‘high risk’ of developing T2DM, is urgently needed, particularly in resource-constrained settings. This paper describes the protocol for a cluster randomised controlled trial of a peer-led lifestyle intervention program to prevent diabetes in Kerala, India.Methods/designA total of 60 polling booths are randomised to the intervention arm or control arm in rural Kerala, India. Data collection is conducted in two steps. Step 1 (Home screening): Participants aged 30–60 years are administered a screening questionnaire. Those having no history of T2DM and other chronic illnesses with an Indian Diabetes Risk Score value of ≥60 are invited to attend a mobile clinic (Step 2). At the mobile clinic, participants complete questionnaires, undergo physical measurements, and provide blood samples for biochemical analysis. Participants identified with T2DM at Step 2 are excluded from further study participation. Participants in the control arm are provided with a health education booklet containing information on symptoms, complications, and risk factors of T2DM with the recommended levels for primary prevention. Participants in the intervention arm receive: (1) eleven peer-led small group sessions to motivate, guide and support in planning, initiation and maintenance of lifestyle changes; (2) two diabetes prevention education sessions led by experts to raise awareness on T2DM risk factors, prevention and management; (3) a participant handbook containing information primarily on peer support and its role in assisting with lifestyle modification; (4) a participant workbook to guide self-monitoring of lifestyle behaviours, goal setting and goal review; (5) the health education booklet that is given to the control arm. Follow-up assessments are conducted at 12 and 24 months. The primary outcome is incidence of T2DM. Secondary outcomes include behavioural, psychosocial, clinical, and biochemical measures. An economic evaluation is planned.DiscussionResults from this trial will contribute to improved policy and practice regarding lifestyle intervention programs to prevent diabetes in India and other resource-constrained settings.Trial registrationAustralia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

【 授权许可】

CC BY   
© Sathish et al.; licensee BioMed Central Ltd. 2013