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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.