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Open Access Highly Accessed Study protocol

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

Thirunavukkarasu Sathish1*, Emily D Williams2, Naanki Pasricha1, Pilvikki Absetz3, Paula Lorgelly4, Rory Wolfe1, Elezebeth Mathews5, Zahra Aziz1, Kavumpurathu Raman Thankappan5, Paul Zimmet6, Edwin Fisher7, Robyn Tapp8, Bruce Hollingsworth9, Ajay Mahal1, Jonathan Shaw16, Damien Jolley1, Meena Daivadanam105 and Brian Oldenburg1

Author Affiliations

1 School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

2 National Heart and Lung Institute, Imperial College London, London, UK

3 University of Tampere, Tampere, Finland

4 Centre for Health Economics, Monash University, Melbourne, Australia

5 Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, Kerala, India

6 Baker IDI Heart and Diabetes Institute, Melbourne, Australia

7 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

8 Optometry and Vision Sciences, University of Melbourne, Melbourne, Australia

9 Division of Health Research, Lancaster University, Lancaster, UK

10 Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden

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BMC Public Health 2013, 13:1035  doi:10.1186/1471-2458-13-1035

Published: 4 November 2013

Abstract

Background

India 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/design

A 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.

Discussion

Results 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 registration

Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.

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