Clinical trial NCT05031221: Feasibility and Impact of Yoga in Obesity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Obesity
Weight Loss
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Proof-of-Concept, single-arm study
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Enrollment
timeFrame: 12 weeks before intervention initiation
measure: Retention
timeFrame: At intervention completion (12 weeks)
measure: Collection of secondary outcome measures at baseline
timeFrame: Baseline (week 0)
measure: Collection of secondary outcome measures at follow-up
timeFrame: Intervention completion (12 weeks)
measure: Acceptability during the intervention
timeFrame: Week 6
measure: Acceptability after the intervention
timeFrame: Week 12
measure: Adherence
timeFrame: Weekly during the 12 week intervention
measure: Adverse events (intervention safety)
timeFrame: Weekly during the 12-week intervention
Secondary outcomes:
measure: Body weight change
timeFrame: Week 0 and 12
measure: Resting metabolic rate (RMR) change
timeFrame: Week 0 and 12
measure: Body composition change
timeFrame: Week 0 and 12
measure: Glucose tolerance change
timeFrame: Week 0 and 12
measure: Cardiometabolic health change
timeFrame: Week 0 and 12
measure: Heart rate variability change
timeFrame: Week 0 and 12
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado - Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Ann E Caldwell, PhD
role: PRINCIPAL_INVESTIGATOR
References: