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Table 1 Measurement domains, tools, and data collection time points (baseline, 12 months and 24 months)

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

Variable Component Measurement tools/questions Baseline 12 months 24 months
Socio-demographic measures   Age, sex, marital status, education, religion, occupation, household size, and monthly household expenditure
Behavioural measures Tobacco use WHO STEPS questionnaire [38]
  Alcohol use WHO STEPS questionnaire [38]
  Physical activity Global Physical Activity Questionnaire [39]
  Sedentary behaviour Time spent in front of a screen [40]
  Diet Food Frequency Questionnaire adapted from PROLIFE study [41]
Diabetes knowledge Barriers to healthy eating Scale designed for trial
  Barriers to physical activity Adapted from the scale designed by Booth et al. [42]
  Self-efficacy (diet and physical activity) Adapted from the Nutrition and physical Activity self-efficacy scales designed by Schwarzer and Renner [43]
Psychosocial measures Depression Patient Health Questionnaire-9 amended in line with CURES-65 study [44]
  Stress Chronic stress scale used in MESA study [45, 46]
  Anxiety General anxiety disorder scale [47]
  Health-related quality of life Short Form-36 [48]
  Social support ENRICHD social support scale [49]
  Life satisfaction How satisfied are you with your life as a whole?
Medical history   Use of any medications, family history of diabetes, heart disease or stroke, history of hypertension, and history of high cholesterol
Clinical measures Anthropometry Waist circumference (Seca measuring tape) [38] Hip circumference [38]
Height (Seca stadiometer) [38]
Weight (TANITA body composition analyser) [38]
Bioimpedance (TANITA body composition analyser) [38]
  Blood pressure Omron automatic blood pressure monitor [38]
Biochemical measures Pathology Glycaemic control (fasting plasma glucose and 2 hour post load glucose, HbA1c), lipid profile (total cholesterol, HDL, LDL, triglycerides), and fibrinogen
Cost effectiveness analysis Healthcare utilisation Direct and indirect costs associated with outpatient and inpatient healthcare services, sources of financing, and time away from work due to ill health
Program evaluation Knowledge assessment Pre and post test   
  Training evaluation Appropriateness of training   
  Group session evaluation Quality, appropriateness and usefulness of group sessions, engagement/involvement and ongoing support 4 months 8 months 12 months
  Other evaluation Use of peer leader workbook, participant handbook, implementation fidelity and challenges and barriers 4 months 8 months 12 months
  1. Abbreviations: WHO STEPS World Health Organization Stepwise approach to surveillance, PROLIFE Population registry of lifestyle diseases, CURES Chennai urban rural epidemiological study, MESA Multi-ethnic study of atherosclerosis, ENRICHD Enhancing recovery in coronary heart disease, HbA1c Glycosylated haemoglobin, HDL High density lipoprotein, LDL Low density lipoprotein.