Feasibility and Impact of Yoga in Obesity

Obesity Clinical Trial

— SYNERGY  

Official title:

A Proof-of-Concept Study Examining the Addition of Yoga to a Behavioral Weight Loss Intervention on Energy Balance and Health-Related Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031221
• Other study ID #: 21-3690
• Status: Completed
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: August 15, 2022

Study information

• Verified date: December 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: August 15, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Adults age 18-55

• Body mass index (BMI) 27-45 kg/m2

• Live or work within 30 miles of the University of Colorado Anschutz Health and Wellness Center

• Passing medical and physical screening

• Agree to fast for 12 hours before the baseline and follow-up visits

• Sedentary: defined as <150 minutes per week of voluntary exercise at moderate intensity or greater and < 60 min per day of total habitual PA (i.e. work related, transportation related) at moderate intensity or greater, over the past 3 months.

• Not currently practicing yoga regularly over past 6 months

• Among women: Not currently pregnant or lactating, not planning to become pregnant in the next 12 weeks

• English speaking, as the intervention will be delivered in English

Exclusion Criteria:

• Diastolic blood pressure > 100 mm HG or systolic blood pressure > 160 mm HG

• Resting heart rate >100

• Diabetes (fasting glucose =126 mg/dL or Hemoglobin A1C =6.5%)

• Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range) or history of uncontrolled thyroid disorder.

• Abnormal values of: hematocrit, white blood cell count or platelets

• Triglycerides > 400 mg/dL

• LDL cholesterol >200 mg/dL

• Abnormal resting electrocardiogram (ECG)

• Presence or history of any self-reported metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to optimally participate in the exercise component

• Significant self-reported pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.

• Self-reported symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.

• Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism

• Regular use of systemic steroids (other than Oral Contraceptive Pills).

• Regular use of obesity pharmacotherapeutic agents within the last 6 months.

• Previous obesity treatment with surgery or weight loss device

• Current alcohol or substance abuse

• Nicotine use (past 6 months)

• History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder.

• Current severe depression or history of severe depression within the previous year

• History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary or exercise interventions.

• Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.

• Participation in a weight loss program using the Colorado Weigh curriculum within the past 3 years

• Weight loss >5kg in past 3 months for any reason except post-partum weight loss

• Weight loss of >50 lbs in past 3 years for any reason except post-partum weight loss.

Related Conditions & MeSH terms

• Obesity
• Weight Loss
• Yoga

Intervention

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).

Locations

Country	Name	City	State
United States	University of Colorado - Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	Ability to enroll 12-20 participants	12 weeks before intervention initiation
Primary	Retention	Attrition >20%	At intervention completion (12 weeks)
Primary	Collection of secondary outcome measures at baseline	Percent completion of the cardiometabolic, psychological, and energy balance outcome measures	Baseline (week 0)
Primary	Collection of secondary outcome measures at follow-up	Percent completion of the cardiometabolic, psychological, and energy balance outcome measures	Intervention completion (12 weeks)
Primary	Acceptability during the intervention	Participant satisfaction with the intervention on a 1-10 Likert scale	Week 6
Primary	Acceptability after the intervention	Participant satisfaction with the intervention on a 1-10 Likert scale	Week 12
Primary	Adherence	Percent completion of intervention sessions	Weekly during the 12 week intervention
Primary	Adverse events (intervention safety)	Study-related adverse events	Weekly during the 12-week intervention
Secondary	Body weight change	Body weight in kg	Week 0 and 12
Secondary	Resting metabolic rate (RMR) change	RMR in kcal/day	Week 0 and 12
Secondary	Body composition change	Fat mass and fat-free mass as measured by dual X-ray absorptiometry	Week 0 and 12
Secondary	Glucose tolerance change	2-hour oral glucose tolerance	Week 0 and 12
Secondary	Cardiometabolic health change	As measured by cholesterol, triglycerides, high- and low-density lipoproteins	Week 0 and 12
Secondary	Heart rate variability change	As measured by a 12-minute sit to stand protocol with heart rate monitor	Week 0 and 12