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Integration of Yoga for the Treatment of Obesity in Adults

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ClinicalTrials.gov Identifier: NCT03459937
Recruitment Status : Recruiting
First Posted : March 9, 2018
Last Update Posted : April 27, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
John M. Jakicic, PhD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Obesity Physical Activity Weight Loss Weight Change, Body Behavioral: Hatha Yoga Intervention Behavioral: Vinyasa Yoga Intervention Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to one of two intervention conditions, with assessments occurring at pre-intervention and post-intervention.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Outcomes assessors will be masked to intervention condition. Selected investigators who are overseeing the intervention will also be masked to study outcomes.
Primary Purpose: Treatment
Official Title: Integration of Yoga and Mindfulness for the Treatment of Obesity in Adults
Actual Study Start Date : April 25, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hatha Yoga Intervention
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
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.

Experimental: Vinyasa Yoga Intervention
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
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.




Primary Outcome Measures :
  1. Fidelity to the yoga interventions [ Time Frame: Across the 6 month intervention period ]
    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

  2. Compliance to the yoga interventions [ Time Frame: Across the 6 month intervention period ]
    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


Other Outcome Measures:
  1. Weight [ Time Frame: Change at 6 months ]
    Body weight will be assessed in kilograms

  2. Height [ Time Frame: Change at 6 months ]
    Height will be measured in centimeters

  3. Body Mass Index (BMI) [ Time Frame: Change at 6 months ]
    measures of weight and height will be combined to report BMI in kg/m2

  4. Cardiorespiratory Fitness [ Time Frame: Change at 6 months ]
    Cardiorespiratory fitness will be measured using a submaximal graded exercise test.

  5. Physical Activity Counts [ Time Frame: Change at 6 months ]
    Physical activity counts will be assessed using actigraphy.

  6. Physical Activity minutes [ Time Frame: Change at 6 months ]
    Physical activity minutes will be assessed using questionnaires.

  7. Physical Activity Energy Expenditure [ Time Frame: Change at 6 months ]
    Physical activity energy expenditure (kcal/week) will be assessed using questionnaires.

  8. Dietary Intake [ Time Frame: Change at 6 months ]
    Dietary intake (kcal/day) will be measured using a food frequency questionnaire

  9. Sedentary Behavior Duration [ Time Frame: Change at 6 months ]
    Sedentary behavior duration (minutes) will be assessed using questionnaires

  10. Sedentary Behavior Counts [ Time Frame: Change at 6 months ]
    Sedentary behavior will be assessed from counts using actigraphy

  11. Physical activity barriers [ Time Frame: Change at 6 months ]
    Physical activity barriers will be assessed with a questionnaire

  12. Eating behaviors [ Time Frame: Change at 6 months ]
    Eating behaviors will be assessed with questionnaires

  13. Mindfulness [ Time Frame: Change at 6 months ]
    Mindfulness will be assessed with questionnaires

  14. Psychological flexibility [ Time Frame: Change at 6 months ]
    Psychological flexibility will be assessed with questionnaires

  15. Self-regulation [ Time Frame: Change at 6 months ]
    Self-regulation will be assessed with questionnaires

  16. Affect [ Time Frame: Change at 6 months ]
    Affect will be assessed with a questionnaire

  17. Depressive symptoms [ Time Frame: Change at 6 months ]
    Depressive symptoms will be assessed with questionnaires

  18. Anxiety [ Time Frame: Change at 6 months ]
    Anxiety will be assessed with questionnaires

  19. Sleep time [ Time Frame: Change at 6 months ]
    Sleep time will be assessed with a questionnaire

  20. Sleep quality [ Time Frame: Change at 6 months ]
    Sleep quality will be assessed with a questionnaire

  21. Sleep duration [ Time Frame: Change at 6 months ]
    Sleep duration will be assessed with counts from actigraphy



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Both males and females of all race/ethnic groups are eligible for participation in this study.
  • 18-60 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03459937


Contacts
Contact: John M Jakicic, PhD 412-383-4020 jjakicic@pitt.edu
Contact: Renee J Rogers, PhD 412-383-4020 rjr26@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: John M. Jakicic, PhD    412-488-4184    jjakicic@pitt.edu   
Principal Investigator: John M. Jakicic, PhD         
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: John M Jakicic, PhD University of Pittsburgh

Responsible Party: John M. Jakicic, PhD, Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03459937     History of Changes
Other Study ID Numbers: R34AT009361 ( U.S. NIH Grant/Contract )
R34AT009361 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by John M. Jakicic, PhD, University of Pittsburgh:
obesity
yoga
mindfulness
weight loss
physical activity

Additional relevant MeSH terms:
Obesity
Body Weight
Weight Loss
Body Weight Changes
Overnutrition
Nutrition Disorders
Overweight
Signs and Symptoms