Methodology of 2017, a Nationwide Multicentric Trial on the Effect of a Validated Culturally Acceptable Lifestyle Intervention for Primary Prevention of Diabetes: Part 2.

BACKGROUND

The rapidly increasing diabetes burden, reaching epidemic proportions despite decades of efforts, reflects our failure to translate the proven evidence for prevention of diabetes. Yoga, with its holistic approach, alters the habituated patterns of lifestyles and behaviour. Motivated by the accumulating evidence, the Government of India funded a large randomized controlled trial.

AIMS AND OBJECTIVES

The twin objectives were: (a) estimate the prevalence of prediabetes and diabetes through a parallel multisite stratified cluster sampling method and (b) implement NMB 2017 (), a randomized control trial using yoga based lifestyle program.

MATERIALS AND METHODS

Screening for Indian Diabetes Risk score(IDRS) was conducted in randomly selected clusters in all 7 zones (65 districts from 29 states/union territories) of India. This was followed by detailed assessments in those with known diabetes and high risk (≥60) on IDRS. Those who satisfied the selection criteria and consented were recruited for the two armed waitlisted randomized control trial. A validated remedial diabetesspecific integrated yoga lifestyle module was taught to the experimental arm by certified volunteers of Indian Yoga Association. Followup assessments were done after 3 months in both groups. In this article, we report the methodology of the trial.

RESULTS

Response to door to door visits (n-240,968 adults >20yrs) in randomly selected urban and rural households for screening was 162,330; detailed assessments (A1c, lipid profile, BMI, stress, tobacco etc) were performed on 50,199 individuals. Of these 12466 (6531 yoga 5935 control) consented and for the RCT; 52% females, 48% males; 38% rural, 62% urban; BMI 21.1 ± 3.8; waist circumference 91.7 ± 11.9. A1c in diabetes subjects in yoga group was 7.63 ± 2.17 and 7.86 ± 2.13 in control group.

CONCLUSION

This unique methodology provides the evidence to implement a validated yoga life style module using yoga volunteers in all parts of the country which is an urgent need to prevent India from becoming the global capital for diabetes.