Clinical trial NCT06636773: Comparision of Aerobic Exercise to Aerobic Plus Yoga Exercise for Weight Loss in Adults With Overweight or Obesity.
Official title: Effectiveness of the Addition of Yoga to a Behavioral Weight Loss Intervention for Adults With Overweight or Obesity (MOVE for Health)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Keywords: obesity
overweight
exercise
physical activity
yoga
weight loss
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-10-15
Enrollment: 290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Report moderate-to-vigorous exercise on \&gt;3 days/week or a total of \&gt;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.

Primary outcomes:
measure: Body Weight
timeFrame: 0, 3, 6, 9, 12 months
Secondary outcomes:
measure: Body Mass Index
timeFrame: 0, 3, 6, 9, 12 months
measure: Percent body fat
timeFrame: 0, 6, 12 months
measure: Body Fat Mass
timeFrame: 0, 6, 12 months
measure: Lean Body Mass
timeFrame: 0, 6, 12 months
measure: Bone mineral content
timeFrame: 0, 6, 12 months
measure: Waist Circumference
timeFrame: 0, 6, 12 months
measure: Cardiorespiratory Fitness
timeFrame: 0, 6, 12 months
measure: Cardiorespiratory Fitness
timeFrame: 0, 6, 12 months
measure: Cardiorespiratory Fitness
timeFrame: 0, 6, 12 months
measure: Energy Intake (Dietary Intake)
timeFrame: 0, 3, 6, 9, 12 months
measure: Dietary Cognitive Restraint
timeFrame: 0, 3, 6, 9, 12 months
measure: Dietary Disinhibition
timeFrame: 0, 3, 6, 9, 12 months
measure: Hunger
timeFrame: 0, 3, 6, 9, 12 months
measure: Weight Loss Strategies
timeFrame: 0, 3, 6, 9, 12 months
measure: Weight Loss Strategies
timeFrame: 0, 3, 6, 9, 12 months
measure: Mood/Affect
timeFrame: 0, 3, 6, 9, 12 months
measure: Perceived Stress
timeFrame: 0, 3, 6, 9, 12 months
measure: Depressive Symptoms
timeFrame: 0, 3, 6, 9, 12 months
measure: Mindfulness
timeFrame: 0, 3, 6, 9, 12 months
measure: Mindfulness Practice
timeFrame: 0, 3, 6, 9, 12 months
measure: Sleep
timeFrame: 0, 3, 6, 9, 12 months
measure: Acute Physical Activity Test - perceived distress
timeFrame: Between weeks 2-6, at 6 months, at 12 months
measure: Acute Physical Activity Test - Mood
timeFrame: Between weeks 2-6, at 6 months, at 12 months
measure: Acute Physical Activity Test - Sleepiness
timeFrame: Between weeks 2-6, at 6 months, at 12 months
measure: Acute Physical Activity Test - Hunger
timeFrame: Between weeks 2-6, at 6 months, at 12 months
measure: Acute Physical Activity Test - Cortisol
timeFrame: Between weeks 2-6, at 6 months, at 12 months
Other outcomes:
measure: Medication History
timeFrame: 0, 3, 6, 9, 12 months
measure: Lifestyle and Health History
timeFrame: 0 months (prior to randomization)
measure: Adverse and Serious Adverse Events
timeFrame: 0, 3, 6, 9, 12 months and at other times when reported by the participant
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: John M. Jakicic, PhD
role: PRINCIPAL_INVESTIGATOR
References: