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Randomized Controlled Trial
. 2017 May;34(5):647-653.
doi: 10.1111/dme.13165. Epub 2016 Jul 15.

Baseline characteristics of participants in the Kerala Diabetes Prevention Program: a cluster randomized controlled trial of lifestyle intervention in Asian Indians

T Sathish  1 , B Oldenburg  1 , R J Tapp  1   2 , J E Shaw  3 , R Wolfe  4 , B Sajitha  5 , F D'Esposito  1 , P Absetz  6   7 , E Mathews  5 , P Z Zimmet  3 , K R Thankappan  5
Affiliations
Randomized Controlled Trial

Baseline characteristics of participants in the Kerala Diabetes Prevention Program: a cluster randomized controlled trial of lifestyle intervention in Asian Indians

T Sathish et al. Diabet Med. 2017 May.

Abstract

Aims: To describe the baseline characteristics of participants in the Kerala Diabetes Prevention Program.

Methods: The Kerala Diabetes Prevention Program is a cluster randomized controlled trial of lifestyle intervention for prevention of Type 2 diabetes mellitus in India. Participants in the study were those aged 30-60 years who had an Indian Diabetes Risk Score ≥ 60 and who were without Type 2 diabetes on oral glucose tolerance test. Data on demographic, lifestyle, clinical and biochemical characteristics were collected using standardized tools.

Results: A total of 2586 individuals were screened with the Indian Diabetes Risk Score, of these 1529 people (59.1%) had a score ≥ 60, of whom 1209 (79.1%) underwent an oral glucose tolerance test. A total of 202 individuals (16.7%) had undiagnosed Type 2 diabetes and were excluded, and the remaining 1007 individuals were enrolled in the trial (control arm, n = 507; intervention arm, n = 500). The mean participant age was 46.0 ± 7.5 years, and 47.2% were women. The mean Indian Diabetes Risk Score was 67.1 ± 8.4. More than two-thirds (69.0%) had prediabetes and 31.0% had normal glucose tolerance. The prevalence of cardiometabolic risk factors was high, including current tobacco use (34.4% in men), current alcohol use (39.3% in men), no leisure time exercise (98.0%), no daily intake of fruit and vegetables (78.7%), family history of diabetes (47.9%), overweight or obesity (68.5%), hypertension (22.3%) and dyslipidemia (85.4%).

Conclusions: The Kerala Diabetes Prevention Program recruited participants using a diabetes risk score. A large proportion of the participants had prediabetes and there were high rates of cardiometabolic risk factors. The trial will evaluate the effectiveness of lifestyle intervention in a population selected on the basis of a diabetes risk score.

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Figures

FIGURE 1
FIGURE 1
Flow chart showing the screening and enrolment of participants in the Kerala Diabetes Prevention Programme. IDRS, Indian Diabetes Risk Score.
See this image and copyright information in PMC

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