Effectiveness of a Yoga-Based Lifestyle Protocol (YLP) in Preventing Diabetes in a High-Risk Indian Cohort: A Multicenter Cluster-Randomized Controlled Trial (NMB-Trial)

Abstract

IntroductionThough several lines of evidence support the utility of yoga-based interventions in diabetes prevention, most of these studies have been limited by methodological issues, primarily sample size inadequacy. Hence, we tested the effectiveness of yoga-based lifestyle intervention against diabetes risk reduction in multicentre, large community settings of India, through a single-blind cluster-randomized controlled trial, Niyantrita Madhumeha Bharat Abhiyan (NMB). Research Design and MethodsNMB-trial is a multicentre cluster-randomized trial conducted in 80 clusters [composed of rural units (villages) and urban units (Census Enumeration Blocks)] randomly assigned in a 1:1 ratio to intervention and control groups. Participants were individuals (age, 20–70 years) with prediabetes (blood HbA1c values in the range of 5.7–6.4%) and IDRS ≥ 60. The intervention included the practice of yoga-based lifestyle modification protocol (YLP) for 9 consecutive days, followed by daily home and weekly supervised practices for 3 months. The control cluster received standard of care advice for diabetes prevention. Statistical analyses were performed on an intention-to-treat basis, using available and imputed datasets. The primary outcome was the conversion from prediabetes to diabetes after the YLP intervention of 3 months (diagnosed based upon HbA1c cutoff >6.5%). Secondary outcome included regression to normoglycemia with HbA1c <5.7%.ResultsA total of 3380 (75.96%) participants were followed up at 3 months. At 3 months post-intervention, overall, diabetes developed in 726 (21.44%) participants. YLP was found to be significantly effective in halting progression to diabetes as compared to standard of care; adjusted RRR was 63.81(95% CI = 56.55–69.85). The YLP also accelerated regression to normoglycemia [adjusted Odds Ratio (adjOR) = 1.20 (95% CI, 1.02–1.43)]. Importantly, younger participants (≤40 years) were found to regress to normoglycemia more effectively than the older participants Pinteraction<0.001. ConclusionBased on the significant risk reduction derived from the large sample size, and the carefully designed randomized yoga-based intervention on high-risk populations, the study is a preliminary but strong proof-of-concept for yoga as a potential lifestyle-based treatment to curb the epidemic of diabetes. The observed findings also indicate a potential of YLP for diabetes prevention in low/moderate risk profile individuals that needs large-scale validation.Trial RegistrationClinical Trial Registration Number: CTRI/2018/03/012804.

The effectiveness of lifestyle interventions on type 2 diabetes and gestational diabetes incidence and cardiometabolic outcomes: A systematic review and meta-analysis of evidence from low- and middle-income countries

“…Study characteristics and descriptions of the interventions and main findings of eligible studies are summarised quantitatively in Table 1 , and qualitatively reviewed in the appendix (pp 14-23). The majority of the eligible studies were published in the last decade, 2012-2022, (90%), and conducted in lower-middle (56%) 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 or upper-middle-income (44%) 23 , 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 countries. No eligible study was found in low-income countries.…”

“…No eligible study was found in low-income countries. By continent, the vast majority of studies (84%) were performed in Asia (15 in India, 25 , 27 , 28 , 29 , 32 , 33 , 35 , 36 , 41 , 42 , 44 , 46 , 47 , 48 , 50 12 in China, 53 , 54 , 55 , 56 , 57 , 58 , 60 , 61 , 63 , 66 , 67 , 68 five in Iran, 31 , 37 , 40 , 43 , 45 two in Thailand, 51 , 65 Vietnam, 30 , 49 Bangladesh, 24 , 32 and Sri Lanka, 26 , 32 and one in Jordan, 69 Pakistan, 39 and Mongolia 38 ), followed (14%) by America (three in Brasil, 52 , 64 , 70 two in Colombia, 23 , 62 and one in Cuba 59 ), and only one study (2%) in Africa (Egypt 34 ). To define at-risk populations, most studies selected participants with impaired glucose/prediabetes (52%) or presenting a combination of cardiometabolic risks (34%).…”

“…As per eligibility criteria, all interventions were evaluated using an RCT design with 74% of studies using individually randomisation 23 , 26 , 27 , 28 , 29 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 47 , 50 , 52 , 53 , 54 , 55 , 56 , 59 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 and 26% clustered randomisation. 24 , 25 , 30 , 31 , 45 , 46 , 48 , 49 , 51 , 57 , 58 , 60 When appraising the risk of bias using RCT-specific tools, 54% of studies were ranked as having medium risk, 23 , 26 , 28 , 29 , 33 , 35 , 36 , 37 , 39 , 42 , 43 , 45 , 46 , 47 , 48 ,...…”

“…As an alternative approach, we reviewed the characteristics of the interventions reporting the outcome of T2D incidence that were ranked as low risk of bias and had the greatest weights in the meta-analysis. This approach revealed that an 3-month yoga-based lifestyle intervention reduced the incidence of T2D by 64% 25 while a 12-month lifestyle intervention focused on preventing weight gain after GDM 32 and an 18-month mHealth intervention, encouraging a healthy lifestyle and awareness of T2D, 24 did not have an effect on reducing the onset of T2D. This qualitative analysis exemplifies the heterogeneity in the design of effective interventions and points to the need for contextualised intervention components and overall strategies.…”

Diabetic yoga protocol improves glycemic, anthropometric and lipid levels in high risk individuals for diabetes: a randomized controlled trial from Northern India

“…This is the first protocol to be made specifically for the prediabetics and diabetics. The complete sequence of prayer, yogic postures, breathing and meditative techniques, along with specified time, was shown in previously published paper [ 24 ]. The Yogic practices were performed for 3 months for 60 min.…”