Comparision of Aerobic Exercise to Aerobic Plus Yoga Exercise for Weight Loss in Adults With Overweight or Obesity.
Effectiveness of the Addition of Yoga to a Behavioral Weight Loss Intervention for Adults With Overweight or Obesity (MOVE for Health)
2 other identifiers
interventional
290
1 country
1
Brief Summary
The goal of this clinical trial is to learn whether adding yoga exercise to a behavioral weight loss intervention improves weight loss in adults with overweight or obesity. It will also provide information about whether this approach to weight loss has additional benefits on other health and fitness measurements. The main questions it aims to answer are:
- Is there a difference in weight loss between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in how much physical activity is completed between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in body composition (fat mass, lean body mass) between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in cardiorespiratory fitness the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in muscle strength between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in resting blood pressure between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in food intake or eating behaviors between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in feelings of stress or mood between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in sleep between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise?
- Is there a difference in the change in mindfulness between the behavioral program that includes aerobic exercise plus yoga compared to the behavioral program that includes only aerobic exercise? Participants will:
- Participate in a weight loss program for a period of 12 months that involves attending behavioral weight loss sessions. This involves coming to a session at the research center weekly for the initial 6 months and then every other week for the remaining 6 months.
- Attempt to reduce the amount of food that they eat to reduce the calories they consume.
- Participate in a combination of aerobic exercise plus yoga or just aerobic exercise.
- Keep a record of the food they consume, use a digital scale provided to them, and wear an activity tracker provided to them for the period of 12 months.
- Visit the clinical before starting the weight loss program, after 3 months, 6 months, 9 months, and 12 months to complete measurements of their weight and other measurements to monitor their progress.
- Complete exercise sessions in the clinic between weeks 2-6, at month 6, and at month 12 to provide information about how they response to a single session of exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
October 15, 2024
CompletedStudy Start
First participant enrolled
January 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2029
January 9, 2026
January 1, 2026
3.9 years
October 4, 2024
January 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
0, 3, 6, 9, 12 months
Secondary Outcomes (26)
Body Mass Index
0, 3, 6, 9, 12 months
Percent body fat
0, 6, 12 months
Body Fat Mass
0, 6, 12 months
Lean Body Mass
0, 6, 12 months
Bone mineral content
0, 6, 12 months
- +21 more secondary outcomes
Other Outcomes (3)
Medication History
0, 3, 6, 9, 12 months
Lifestyle and Health History
0 months (prior to randomization)
Adverse and Serious Adverse Events
0, 3, 6, 9, 12 months and at other times when reported by the participant
Study Arms (2)
Behavioral Weight Loss Plus Aerobic Physical Activity
EXPERIMENTALThe intervention is a 12-month behavioral intervention focused on modifying eating behaviors and physical activity. Participants will be provided weekly group-based behavioral session for months 1-6, with these sessions being offered twice per month during months 7-12. Participants will be instructed to self-monitor their weight, eating behaviors, and physical activity. A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants. Physical activity will be recommended in the form of aerobic types of activity such as brisk walking and will progress from an initial amount of 100 minutes per week to 300 minutes per week across the initial 6 months of the intervention, with this level of physical activity continuing to be recommended between months 7-12.
Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga
EXPERIMENTALThe intervention is a 12-month behavioral intervention focused on modifying eating behaviors and physical activity. Participants will be provided weekly group-based behavioral session for months 1-6, with these sessions being offered twice per month during months 7-12. Participants will be instructed to self-monitor their weight, eating behaviors, and physical activity. A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants. Physical activity will be recommended in the form of aerobic types of activity such as brisk walking combined with yoga. Aerobic activity will progress from an initial amount of 60 minutes per week to 180 minutes per week across the initial 6 months of the intervention, with this level continuing to be recommended between months 7-12. Yoga will progress from 40 minutes per week to 120 minutes per week across the initial 6 months of the intervention, with this level continuing to be recommended between months 7-12.
Interventions
A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants.
Physical activity will be recommended in the form of aerobic types of activity such as brisk walking and will progress from an initial amount of 100 minutes per week to 300 minutes per week across the initial 6 months of the intervention, with this level of physical activity continuing to be recommended between months 7-12.
Participants will be provided weekly group-based behavioral session for months 1-6, with these sessions being offered twice per month during months 7-12 to assist in supporting recommended changes in energy intake (diet) and physical activity.
Physical activity will be recommended in the form of a combination of aerobic types of activity, such as brisk walking, and yoga. Aerobic activity will progress from 60 minutes per week to 180 minutes per week across the initial 6 months of the intervention. Yoga will progress from 40 minutes per week to 120 minutes per week across the initial 6 months of the intervention. When combined this will progress from a total of 100 minutes per week to 300 minutes per week across the initial 6 months of treatment. This level of physical activity will continue to be recommended between months 7-12.
Eligibility Criteria
You may qualify if:
- Both males and females of all race/ethnic groups are eligible for participation in this study.
- at least 18 years of age. The investigators will not limit enrollment based on an upper age provided that the participant meets the other eligibility requirements.
- Body mass index (BMI) of at least 25.0 kg/m2. The investigators will not limit enrollment based on an upper BMI level provided that the participant meets the other eligibility requirements. However, maximal weight to be eligible will be 350 pounds to meet the weight requirements for the equipment that will be used in this study.
- 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/week or a total of \>60 min/week over the past 3 months.
- Engaging in any style of yoga on an average of at least 1 day/week over the past 3 months.
- Report weight loss of 3% or more or participating in a weight reduction diet in the past 3 months.
- Currently prescribed an anti-obesity medication.
- Females who are pregnant or breastfeeding or reporting a planned pregnancy during the study period.
- History of bariatric surgery.
- Report a current medical condition or treatment for a medical condition that could affect body weight.
- 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 more or resting diastolic blood pressure of 100 mmHg or more. If medicated for blood pressure control, the medication dose needs to be stable for at least 6 months.
- Eating disorders that would contraindicate weight loss or physical activity.
- Alcohol or substance abuse.
- Current psychological condition that is untreated, hospitalization for a psychological condition within the past 12 months, or not being on a stable dose of treatment for at least 6 months.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John M. Jakicic, PhD
University of Kansas Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 4, 2024
First Posted
October 15, 2024
Study Start
January 3, 2025
Primary Completion (Estimated)
November 30, 2028
Study Completion (Estimated)
February 28, 2029
Last Updated
January 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- The data will be made available no later than the time of an associated publication of study outcomes or at the end of the performance period, whichever comes first. The data provided to the repository will be available indefinitely while that repository continues to exist.
- Access Criteria
- The information included with the IPD will be made available to appropriate individuals only after the requester confirms their willingness to comply with an appropriate "Data Use Agreement" that complies with NIH policies, the policies of the institution where the study has been conducted, and the elements of informed consent.
The summary data for each of the study outcomes and other additional demographic characteristics will be made available. The Study Protocol (which includes the statistical analysis plan), Manual of Procedures, Data Collection Forms, and a Data Dictionary to explain the data variables will be provided.