A lifestyle change programme to prevent diabetes in India: the Kerala Diabetes Prevention Program

Completed

• Conditions: Prevention of Type 2 Diabetes

• Registration Number: CTRI/2017/08/009198
• Lead Sponsor: The University of Melbourne

Brief Summary

India has the largest number of individuals with T2DM globally, and this is expected to double by 2030. Thus, the prevention of T2DM, through a combination of individual, community and population based approaches, needs urgent attention. This will be the first implementation trial to target a rural population of India who are at high risk of developing T2DM by using a validated risk-assessment tool. In this study, we will use an innovative new approach to screen and intervention that first identifies individuals at ‘high risk’ on the basis of a validated diabetes risk questionnaire. This offers a potentially cost- efficient and low burden approach to screening, which will also enable the detection of those at risk. Our study will evaluate a culturally-appropriate group-delivered lifestyle intervention, already demonstrated to be effective in other populations. We will evaluate the effectiveness and cost–effectiveness of this program in a developing country.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-20
• Study Completion: 2016-10-01
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1007

Inclusion Criteria

Consenting males and females of age 30-60 years on the electoral roll from the 60 selected polling booths.

Exclusion Criteria

Prior diagnosis of T2DM or history of other major illnesses; Current use of medication known to affect glucose tolerance; Mental illness; Pregnancy; Illiteracy; Indian Diabetes Risk Score<55;2 hr plasma glucose of greater than or equal to 11.1 mmol/L; Fasting plasma glucose greater than or equal to 7.0 mmol/L.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Type 2 Diabetes Incidence (assessed using blood tests and oral glucose tolerance tests to measure fasting plasma glucose and 2 hour post-load glucose).	12 and 24 months

Secondary Outcome Measures

Name	Time	Method
Glycosylated haemoglobin (assessed using blood tests)	12 and 24 months
Obesity (Anthropometric measurements used to obtain Body mass index, Waist circumference and Bio impedance)	12 and 24 months
Diet (using self-reported questionnaire)	12 and 24 months
Blood pressure (assessed with electronic sphygmomanometers)	12 and 24 months
Physical activity/sedentary behavior (using self-reported questionnaire)	12 and 24 months
Alcohol Intake (using self-reported questionnaire)	12 and 24 months
Cholesterol (assessed using blood tests and divided into total, HDL, LDL cholesterol)	12 and 24 months
Triglycerides (assessed using blood tests)	12 and 24 months
Smoking (using self-reported questionnaire)	12 and 24 months

Trial Locations

Locations (1)

Sree Chitra Tirunal Institute for Medical Sciences and Technology; 🇮🇳 Thiruvananthapuram, KERALA, India

Sree Chitra Tirunal Institute for Medical Sciences and Technology

🇮🇳Thiruvananthapuram, KERALA, India

Prof KRThakappan MD MPH FAMS

Principal investigator

919447072171

kavumpurathu@yahoo.com