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

Sathish, Thirunavukkarasu, Williams, Emily, Pasricha, Naanki, Absetz, Pilvikki, Lorgelly, Paula, Wolfe, Rory, Mathews, Elezebeth, Aziz, Zahra, Thankappan, Kavumpurathu Raman, Zimmet, Paul , Fisher, Edwin, Tapp, Robyn, Hollingsworth, Bruce, Mahal, Ajay, Shaw, Jonathan, Jolley, Damien, Daivadanam, Meena and Oldenburg, Brian (2013) Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program BMC Public Health, 13 (1).

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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.

Item Type: Article
Divisions : Faculty of Health and Medical Sciences > School of Health Sciences
Authors :
NameEmailORCID
Sathish, ThirunavukkarasuUNSPECIFIEDUNSPECIFIED
Williams, Emilye.d.williams@surrey.ac.ukUNSPECIFIED
Pasricha, NaankiUNSPECIFIEDUNSPECIFIED
Absetz, PilvikkiUNSPECIFIEDUNSPECIFIED
Lorgelly, PaulaUNSPECIFIEDUNSPECIFIED
Wolfe, RoryUNSPECIFIEDUNSPECIFIED
Mathews, ElezebethUNSPECIFIEDUNSPECIFIED
Aziz, ZahraUNSPECIFIEDUNSPECIFIED
Thankappan, Kavumpurathu RamanUNSPECIFIEDUNSPECIFIED
Zimmet, PaulUNSPECIFIEDUNSPECIFIED
Fisher, EdwinUNSPECIFIEDUNSPECIFIED
Tapp, RobynUNSPECIFIEDUNSPECIFIED
Hollingsworth, BruceUNSPECIFIEDUNSPECIFIED
Mahal, AjayUNSPECIFIEDUNSPECIFIED
Shaw, JonathanUNSPECIFIEDUNSPECIFIED
Jolley, DamienUNSPECIFIEDUNSPECIFIED
Daivadanam, MeenaUNSPECIFIEDUNSPECIFIED
Oldenburg, BrianUNSPECIFIEDUNSPECIFIED
Date : 2013
Identification Number : 10.1186/1471-2458-13-1035
Copyright Disclaimer : © 2013 Sathish et al.; licensee 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.
Uncontrolled Keywords : Diabetes; Incidence; India; Kerala; Peer support; Randomised controlled trial; Prevention; Resource-constrained settings; Rural; Intervention
Depositing User : Clive Harris
Date Deposited : 12 Jul 2017 13:30
Last Modified : 12 Jul 2017 13:30
URI: http://epubs.surrey.ac.uk/id/eprint/841618

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