title: Cluster randomised controlled trial of a peer-led lifestyle intervention program: study protocol for the Kerala diabetes prevention program.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australia and New Zealand Clinical Trials Registry: ACTRN12611000262909.
authors.affiliation: School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia. sthi27@student.monash.edu.
authors.forename: Thirunavukkarasu
authors.initials: T
authors.lastname: Sathish
authors.forename: Emily D
authors.initials: ED
authors.lastname: Williams
authors.forename: Naanki
authors.initials: N
authors.lastname: Pasricha
authors.forename: Pilvikki
authors.initials: P
authors.lastname: Absetz
authors.forename: Paula
authors.initials: P
authors.lastname: Lorgelly
authors.forename: Rory
authors.initials: R
authors.lastname: Wolfe
authors.forename: Elezebeth
authors.initials: E
authors.lastname: Mathews
authors.forename: Zahra
authors.initials: Z
authors.lastname: Aziz
authors.forename: Kavumpurathu Raman
authors.initials: KR
authors.lastname: Thankappan
authors.forename: Paul
authors.initials: P
authors.lastname: Zimmet
authors.forename: Edwin
authors.initials: E
authors.lastname: Fisher
authors.forename: Robyn
authors.initials: R
authors.lastname: Tapp
authors.forename: Bruce
authors.initials: B
authors.lastname: Hollingsworth
authors.forename: Ajay
authors.initials: A
authors.lastname: Mahal
authors.forename: Jonathan
authors.initials: J
authors.lastname: Shaw
authors.forename: Damien
authors.initials: D
authors.lastname: Jolley
authors.forename: Meena
authors.initials: M
authors.lastname: Daivadanam
authors.forename: Brian
authors.initials: B
authors.lastname: Oldenburg
mesh_terms: D000328:Adult; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000379:methods; D015397:Program Evaluation; D040242:Risk Reduction Behavior