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Effectiveness of Yoga Lifestyle on Lipid Metabolism in a Vulnerable Population-A Community Based Multicenter Randomized Controlled Trial.

ABSTRACT: Background: Dyslipidemia poses a high risk for cardiovascular disease and stroke in Type 2 diabetes (T2DM). There are no studies on the impact of a validated integrated yoga lifestyle protocol on lipid profiles in a high-risk diabetes population. Methods: Here, we report the results of lipid profile values of 11,254 (yoga 5932 and control 5322) adults (20-70 years) of both genders with high risk (≥60 on Indian diabetes risk score) for diabetes from a nationwide rural and urban community-based two group (yoga and conventional management) cluster randomized controlled trial. The yoga group practiced a validated integrated yoga lifestyle protocol (DYP) in nine day camps followed by daily one-hour practice. Biochemical profiling included glycated hemoglobin and lipid profiles before and after three months. Results: There was a significant difference between groups (p < 0.001 ANCOVA) with improved serum total cholesterol, triglycerides, low-density lipoprotein, and high-density lipoprotein in the yoga group compared to the control group. Further, the regulatory effect of yoga was noted with a significant decrease or increase in those with high or low values of lipids, respectively, with marginal or no change in those within the normal range. Conclusion: Yoga lifestyle improves and regulates (lowered if high, increased if low) the blood lipid levels in both genders of prediabetic and diabetic individuals in both rural and urban Indian communities.

SUBMITTER: Nagarathna R

PROVIDER: S-EPMC8303653 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature

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Effectiveness of Yoga Lifestyle on Lipid Metabolism in a Vulnerable Population-A Community Based Multicenter Randomized Controlled Trial.

Nagarathna Raghuram R Kumar Saurabh S Anand Akshay A Acharya Ishwara N IN Singh Amit Kumar AK Patil Suchitra S SS Latha Ramesh H RH Datey Purnima P Nagendra Hongasandra Ramarao HR

Medicines (Basel, Switzerland) 20210713 7

<b>Background:</b> Dyslipidemia poses a high risk for cardiovascular disease and stroke in Type 2 diabetes (T2DM). There are no studies on the impact of a validated integrated yoga lifestyle protocol on lipid profiles in a high-risk diabetes population. <b>Methods:</b> Here, we report the results of lipid profile values of 11,254 (yoga 5932 and control 5322) adults (20-70 years) of both genders with high risk (≥60 on Indian diabetes risk score) for diabetes from a nationwide rural and urban comm ...[more]

PMID: 34357153

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Project description: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.

Project description:BACKGROUND: Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. OBJECTIVE: It is not known whether a program of moderate intervention might effectively reduce metabolic abnormalities in the general population. DESIGN: Two-arm randomized controlled 1-year trial. PATIENTS: Three hundred and thirty-five patients participated from a dysmetabolic population-based cohort of 375 adults aged 45-64 years in northwestern Italy. MEASUREMENTS: We compared the effectiveness of a general recommendation-based program of lifestyle intervention carried out by trained professionals versus standard unstructured information given by family physicians at reducing the prevalence of multiple metabolic and inflammatory abnormalities. RESULTS: At baseline, clinical/anthropometric/laboratory and lifestyle characteristics of the intervention (n = 169) and control (n = 166) groups were not significantly different. The former significantly reduced total/saturated fat intake and increased polyunsaturated fat/fiber intake and exercise level compared to the controls. Weight, waist circumference, high-sensitivity C-reactive protein, and most of the metabolic syndrome components decreased in the intervention group and increased in the controls after 12 months. Lifestyle intervention significantly reduced metabolic syndrome (odds ratio [OR] = 0.28; 95% CI 0.18-0.44), with a 31% (21-41) absolute risk reduction, corresponding to 3.2 (2-5) patients needing to be treated to prevent 1 case after 12 months. The intervention significantly reduced the prevalence of central obesity (OR = 0.33; 0.20-0.56), and hypertriglyceridemia (OR = 0.48; 0.31-0.75) and the incidence of diabetes (OR = 0.23; 0.06-0.85). CONCLUSION: A lifestyle intervention based on general recommendations was effective in reducing multiple metabolic/inflammatory abnormalities. The usual care by family physicians was ineffective at modifying progressive metabolic deterioration in high-risk individuals.

Project description:BackgroundMetabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications.ObjectiveWe assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting.MethodsIn this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat.ResultsBetween October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08).ConclusionsSimultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention.Trial registrationClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.

Project description:BackgroundMaternal obesity is associated with significant racial disparities. People who identify as non-Hispanic Black and Latinx are at the highest risk related adverse short- and long-term health outcomes (eg, hypertension in pregnancy and postpartum weight retention). Remote lifestyle interventions delivered during and after pregnancy hold promise for supporting healthy weight outcomes; however, few are tested in groups of people who self-identify as non-Hispanic Black and Latinx or address the neighborhood-level and psychosocial factors driving maternal health disparities. Implementing remote lifestyle interventions within community-based programs that serve birthing people may optimize trust and engagement, promote scalability and sustainability, and have the broadest public health impact.ObjectiveThe goal of this trial is to test the effectiveness of a culturally adapted remote lifestyle intervention (Healthy for Two-Home Visiting) implemented within home visiting compared to usual home visiting services on postpartum weight retention among pregnant or postpartum individuals, in particular those who identify as non-Hispanic Black and Latinx. Facilitators and barriers to implementation of the intervention within home visiting will be examined.MethodsWe describe the rationale and protocol for this hybrid type I effectiveness-implementation randomized controlled trial. In this paper, we highlight the community-engaged approach and trial design features that enable the implementation of the intervention within home visiting and demonstrate its applicability to the target population. Participants will be 360 pregnant individuals with overweight or obesity enrolled between 20 and 33 weeks of gestation and randomized 1:1 to Healthy for Two-Home Visiting or usual home visiting services. The primary outcome is weight retention at 6 months post partum, calculated as 6-month postpartum weight minus earliest pregnancy weight (≤18 wk of gestation). The measures of implementation include intervention feasibility, acceptability, reach, adoption, and fidelity. Throughout the paper, we highlight the community input used to improve intervention effectiveness and study implementation and as a strategy to promote maternal health equity.ResultsThis study was funded in June 2021, and recruitment began in April 2023. As of November 2024, we enrolled 90 participants. Data collection to assess the intervention's effectiveness is expected to end in June 2026. Implementation evaluation is expected to conclude in December 2026.ConclusionsThis hybrid type I effectiveness-implementation randomized controlled trial integrates a culturally adapted remote lifestyle intervention into early home visiting services to examine its effectiveness on postpartum weight retention compared to usual home visiting. We anticipate that the study results will enable an understanding of the drivers of successful implementation within a community-based setting to maximize the future sustainability and dissemination of a strategy for reducing long-term obesity and other maternal health disparities.Trial registrationClinicaltrials.gov NCT05619705; https://clinicaltrials.gov/study/NCT05619705.International registered report identifier (irrid)DERR1-10.2196/62847.

Dataset Information

Effectiveness of Yoga Lifestyle on Lipid Metabolism in a Vulnerable Population-A Community Based Multicenter Randomized Controlled Trial.

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Effectiveness of Yoga Lifestyle on Lipid Metabolism in a Vulnerable Population-A Community Based Multicenter Randomized Controlled Trial.

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