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

Thirunavukkarasu Sathish, Emily D Williams, Naanki Pasricha, Pilvikki Absetz, Paula Lorgelly, Rory Wolfe, Elezebeth Mathews, Zahra Aziz, Kavumpurathu Raman Thankappan, Paul Zimmet, Edwin Fisher, Robyn Tapp, Bruce Hollingsworth, Ajay Mahal, Jonathan Shaw, Damien Jolley, Meena Daivadanam, Brian Oldenburg

Research output: Contribution to journalArticle

30 Citations (Scopus)

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.

Original languageEnglish
Article number1035
Number of pages11
JournalBMC Public Health
Volume13
DOIs
Publication statusPublished - 4 Nov 2013
Externally publishedYes

Bibliographical note

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Keywords

  • Adult
  • Cost-Benefit Analysis
  • Diabetes Mellitus, Type 2/epidemiology
  • Female
  • Health Promotion/methods
  • Humans
  • India/epidemiology
  • Male
  • Middle Aged
  • Patient Education as Topic/methods
  • Program Evaluation
  • Risk Reduction Behavior

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