An interventional study of Yoga + behavioral weight loss in Yoga, Obesity and Weight Loss, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Other
Yoga may confer health benefits in people with overweight or obesity that enhance weight loss and weight loss maintenance. This study aims to investigate the feasibility of integrating yoga into an established behavioral weight loss program and describe the effects on glucose control, appetite, dietary intake, physical activity, and psychological health.
Innovative approaches to improve long-term behavioral weight loss (BWL) program outcomes are critically needed. Current BWL programs typically produce modest (\~5-10%) short-term (\~6 month) weight loss, but substantial weight regain by 1-year is common and well-documented. There has been a growing interest in examining the effects of yoga on weight loss and cardio-metabolic disease risk among adults with overweight, obesity, metabolic syndrome, pre-diabetes, and diabetes. Overall, results are somewhat promising, but reviews and meta-analyses all conclude that existing studies suffer from significant methodological shortcomings. Moreover, yoga is broadly, variably, and often incorrectly defined, reflecting how key aspects of traditional yoga practice, with specific mind, body, and breath-based practices were lost in translation when yoga was commercially adopted as a form of exercise in the West. These key aspects warrant inclusion in yoga intervention research.
The overall objectives of the proposed research are to 1) Evaluate the feasibility and acceptability of adding a 12-week traditional, multi-component yoga program to a standard BWL intervention (BWL+yoga), and 2) Explore changes in clinical/cardiometabolic, psychological, and energy balance/behavioral measures relevant for reducing cardio-metabolic disease risk. The yoga intervention was developed in collaboration with a world-renowned expert in traditional yoga practices following three decades of dedicated study, practice, and teaching (Mr. Paul Dallaghan). The program includes specific postures (asana), breathing (pranayama), and meditation (inner focus) techniques performed with an underlying focus on self-awareness delivered in-person and virtually. These specific techniques have been practiced historically and described for their benefits in the original Sanskrit teachings but are often excluded from yoga programs developed in the West. The overarching hypotheses are that these specific Hatha (body-breath) and Pantanjala (mind) yoga practices will be feasible in the context of a BWL, will support the adoption of changes in diet and physical activity, and improve mental and physical health.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 21 is below the median of 77 across 5,084 interventional studies indexed under Obesity.
Browse Obesity studies →University of Colorado, Denver is the lead sponsor of 1,538 studies on the registry; 319 are open to participants now.
Of its 146 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.
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Exclusion Criteria:
In person and virtual yoga + 150 minutes of moderate-to-vigorous physical activity/week + weekly instruction on dietary strategies for weight loss
Behavioral: Yoga + behavioral weight loss
A 12-week, one-arm proof-of-concept and feasibility study will be conducted at the University of Colorado Anschutz Medical Campus (CU-AMC) to assess the processes critical for the success of future randomized trials including: a) Evaluating the feasibility and acceptability of adding a multi-component yoga program to a standard BWL intervention and b) Examining pre-post changes in relevant clinical/cardiometabolic, psychological, and energy balance/behavioral outcomes to inform the design of future trials. Participants will receive a comprehensive, group-based BWL intervention consistent with current guidelines for obesity treatment and a carefully designed multi-component yoga intervention delivered through pre-recorded videos delivered through a cloud-based platform that will be completed in-person and at-home (BWL+yoga).
Enrollment
Ability to enroll 12-20 participants
Time frame: 12 weeks before intervention initiation
Retention
Attrition \>20%
Time frame: At intervention completion (12 weeks)
Collection of secondary outcome measures at baseline
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Time frame: Baseline (week 0)
Collection of secondary outcome measures at follow-up
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Time frame: Intervention completion (12 weeks)
Acceptability during the intervention
Participant satisfaction with the intervention on a 1-10 Likert scale
Time frame: Week 6
Acceptability after the intervention
Participant satisfaction with the intervention on a 1-10 Likert scale
Time frame: Week 12
Adherence
Percent completion of intervention sessions
Time frame: Weekly during the 12 week intervention
Adverse events (intervention safety)
Study-related adverse events
Time frame: Weekly during the 12-week intervention
Body weight change
Body weight in kg
Time frame: Week 0 and 12
Resting metabolic rate (RMR) change
RMR in kcal/day
Time frame: Week 0 and 12
Body composition change
Fat mass and fat-free mass as measured by dual X-ray absorptiometry
Time frame: Week 0 and 12
Glucose tolerance change
2-hour oral glucose tolerance
Time frame: Week 0 and 12
Cardiometabolic health change
As measured by cholesterol, triglycerides, high- and low-density lipoproteins
Time frame: Week 0 and 12
Heart rate variability change
As measured by a 12-minute sit to stand protocol with heart rate monitor
Time frame: Week 0 and 12
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2021 to primary completion in Aug 2022, 12 months.
Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 12 months is below that.
Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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