University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045, United States
NCT Number: NCT05031221
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: 12 weeks before intervention initiation
Ability to enroll 12-20 participants
Time frame: At intervention completion (12 weeks)
Attrition >20%
Time frame: Baseline (week 0)
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Time frame: Intervention completion (12 weeks)
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Time frame: Week 6
Participant satisfaction with the intervention on a 1-10 Likert scale
Time frame: Week 12
Participant satisfaction with the intervention on a 1-10 Likert scale
Time frame: Weekly during the 12 week intervention
Percent completion of intervention sessions
Time frame: Weekly during the 12-week intervention
Study-related adverse events
Time frame: Week 0 and 12
Body weight in kg
Time frame: Week 0 and 12
RMR in kcal/day
Time frame: Week 0 and 12
Fat mass and fat-free mass as measured by dual X-ray absorptiometry
Time frame: Week 0 and 12
2-hour oral glucose tolerance
Time frame: Week 0 and 12
As measured by cholesterol, triglycerides, high- and low-density lipoproteins
Time frame: Week 0 and 12
As measured by a 12-minute sit to stand protocol with heart rate monitor
University of Colorado, Denver
Other
A Proof-of-Concept Study Examining the Addition of Yoga to a Behavioral Weight Loss Intervention on Energy Balance and Health-Related Outcomes
Acronym: SYNERGY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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