Feasibility and Impact of Yoga in Obesity

NCT05031221 | Completed

• 1 other identifier: 21-3690
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Yoga; Obesity; Weight Loss

Outcome Measures

Primary Outcomes (8)

• Enrollment

  Ability to enroll 12-20 participants

  12 weeks before intervention initiation

• Retention

  Attrition \>20%

  At intervention completion (12 weeks)

• Collection of secondary outcome measures at baseline

  Percent completion of the cardiometabolic, psychological, and energy balance outcome measures

  Baseline (week 0)

• Collection of secondary outcome measures at follow-up

  Percent completion of the cardiometabolic, psychological, and energy balance outcome measures

  Intervention completion (12 weeks)

• Acceptability during the intervention

  Participant satisfaction with the intervention on a 1-10 Likert scale

  Week 6

• Acceptability after the intervention

  Participant satisfaction with the intervention on a 1-10 Likert scale

  Week 12

• Adherence

  Percent completion of intervention sessions

  Weekly during the 12 week intervention

• Adverse events (intervention safety)

  Study-related adverse events

  Weekly during the 12-week intervention

Secondary Outcomes (6)

• Body weight change

  Week 0 and 12

• Resting metabolic rate (RMR) change

  Week 0 and 12

• Body composition change

  Week 0 and 12

• Glucose tolerance change

  Week 0 and 12

• Cardiometabolic health change

  Week 0 and 12

Study Arms (1)

Yoga + behavioral weight loss

EXPERIMENTAL

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

Interventions

Yoga + behavioral weight loss BEHAVIORAL

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).

Yoga + behavioral weight loss

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Yoga

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Ann E Caldwell, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Proof-of-Concept, single-arm study

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 1, 2021
• Study Start: August 2, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)