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

• Published in: Diabetic medicine Vol. 34; no. 5; pp. 647 - 653
• Main Authors: Sathish, T., Oldenburg, B., Tapp, R. J., Shaw, J. E., Wolfe, R., Sajitha, B., D'Esposito, F., Absetz, P., Mathews, E., Zimmet, P. Z., Thankappan, K. R.
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.05.2017
• Subjects: Adult; Asian Continental Ancestry Group; Clinical trials; Diabetes; Diabetes Mellitus, Type 2 - ethnology; Diabetes Mellitus, Type 2 - prevention & control; Female; Glucose; Humans; India; Life Style; Lifestyles; Male; Middle Aged; Patient Education as Topic; Prediabetic State - ethnology; Prediabetic State - therapy; Primary Prevention - methods; Risk factors; Risk Reduction Behavior
• ISSN: 0742-3071; 1464-5491
• DOI: 10.1111/dme.13165

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. What's new? Large‐scale use of an oral glucose tolerance test (OGTT) as a prerequisite for entering a diabetes prevention programme is a major financial and practical barrier. The Kerala Diabetes Prevention Program is the first diabetes prevention trial from a low‐ and middle‐income country to use a simple and low‐cost diabetes risk score as a screening tool to identify high‐risk individuals. Of 1209 screen positives, 202 (16.7%) had undiagnosed Type 2 diabetes mellitus on OGTT. The trial will evaluate the effectiveness of lifestyle intervention in a population selected on the basis of a risk score, a large proportion of whom had prediabetes and there were high rates of cardiometabolic risk factors.