Integration of Yoga for the Treatment of Obesity in Adults

NCT03459937 | Completed DMC

• 1 other identifier: R34AT009361
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss Intervention, and to use this information to inform an expanded study to directly test the effectiveness of these interventions on weight loss in adults.

Conditions

Obesity; Physical Activity; Weight Loss; Weight Change, Body

Keywords

obesity; yoga; mindfulness; weight loss; physical activity

Outcome Measures

Primary Outcomes (2)

• Fidelity to the yoga interventions

  Fidelity will be based on the number of days that yoga was performed during the intervention compared to the prescribed number of days that yoga was to be completed in both the Hatha Yoga Group and the Vinyasa Yoga Group

  Across the 6 month intervention period

• Compliance to the yoga interventions

  Compliance will be based on the number of days that the yoga was completed at the prescribed duration compared to the prescribed number of days that yoga was to be completed in both the Hatha Yoga Group and the Vinyasa Yoga Group

  Across the 6 month intervention period

Other Outcomes (21)

• Weight

  Change at 6 months

• Height

  Change at 6 months

• Body Mass Index (BMI)

  Change at 6 months

Study Arms (2)

Hatha Yoga Intervention

EXPERIMENTAL

This intervention will be a behavioral weight loss intervention that includes group intervention session, prescribed dietary recommendations, and inclusion of Hatha Yoga.

Behavioral: Hatha Yoga Intervention

Vinyasa Yoga Intervention

EXPERIMENTAL

This intervention will be a behavioral weight loss intervention that includes group intervention session, prescribed dietary recommendations, and inclusion of Vinyasa Yoga.

Behavioral: Vinyasa Yoga Intervention

Interventions

Hatha Yoga Intervention BEHAVIORAL

Hatha Yoga will focus on a restorative style of Hatha yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period.

Hatha Yoga Intervention

Vinyasa Yoga Intervention BEHAVIORAL

Vinyasa Yoga will focus on a more vigorous form of yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period.

Vinyasa Yoga Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both males and females of all race/ethnic groups are eligible for participation in this study.
• years of age.
• Body mass index (BMI) between 25.0 to \<40.0 kg/m2.
• Ability to provide informed consent prior to participation in this study.
• Ability to provide clearance from their primary care physician to engage in the diet and physical activity components of the weight loss intervention.

You may not qualify if:

• Report moderate-to-vigorous exercise on \>3 days per week or a total of \>60 minutes per week over the past 3 months.
• Engaging in any style of yoga on an average of at least 1 day per week over the past 3 months.
• Report weight loss of \>3% or participating in a weight reduction diet in the past 3 months.
• Females who are pregnant or breastfeeding, or reporting a planned pregnancy during the study period.
• History of bariatric surgery.
• Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
• Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
• Resting systolic blood pressure of \>160 mmHg or resting diastolic blood pressure of \>100 mmHg.
• Eating disorders that would contraindicate weight loss or physical activity.
• Alcohol or substance abuse.
• Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.), taking psychotropic medications within the previous 12 months, or hospitalized for depression within the previous 5 years.
• Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance at scheduled intervention sessions or assessments.
• Physical activity or weight loss deemed to be contraindicated based on response to the cardiorespiratory fitness test that will be conducted as part of the screening procedures.

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (1)

• Jakicic JM, Davis KK, Rogers RJ, Sherman SA, Barr S, Marcin ML, Collins KA, Collins AM, Yuan N, Lang W. Feasibility of Integration of Yoga in a Behavioral Weight-Loss Intervention: A Randomized Trial. Obesity (Silver Spring). 2021 Mar;29(3):512-520. doi: 10.1002/oby.23089. Epub 2021 Feb 2.

  PMID: 33528905 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity; Weight Loss; Body Weight Changes

Condition Hierarchy (Ancestors)

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

Study Officials

• John M Jakicic, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be masked to intervention condition. Selected investigators who are overseeing the intervention will also be masked to study outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to one of two intervention conditions, with assessments occurring at pre-intervention and post-intervention.

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 9, 2018
• Study Start: April 25, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: November 27, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)