Comparision of Aerobic Exercise to Aerobic Plus Yoga Exercise for Weight Loss in Adults With Overweight or Obesity.

Phase

N/A

Condition

Obesity

Diabetes Prevention

Weight Loss

Treatment

Aerobic Exercise

Behavioral Sessions

Diet

Clinical Study ID

NCT06636773

STUDY00160080

R01DK135735-01A1

Ages > 18
All Genders

Study 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

Inclusion Criteria:

Both males and females of all race/ethnic groups are eligible for participation inthis study.
at least 18 years of age. The investigators will not limit enrollment based on anupper 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 limitenrollment based on an upper BMI level provided that the participant meets the othereligibility requirements. However, maximal weight to be eligible will be 350 poundsto 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 dietand physical activity components of the weight loss intervention.

Exclusion

Exclusion Criteria:

Report moderate-to-vigorous exercise on >3 days/week or a total of >60min/week over the past 3 months.
Engaging in any style of yoga on an average of at least 1 day/week over the past 3months.
Report weight loss of 3% or more or participating in a weight reduction diet in thepast 3 months.
Currently prescribed an anti-obesity medication.
Females who are pregnant or breastfeeding or reporting a planned pregnancy duringthe study period.
History of bariatric surgery.
Report a current medical condition or treatment for a medical condition that couldaffect body weight.
Current congestive heart failure, angina, uncontrolled arrhythmia, symptomsindicative of an increased acute risk for a cardiovascular event, prior myocardialinfarction, coronary artery bypass grafting or angioplasty, conditions requiringchronic anticoagulation (i.e., recent or recurrent DVT).
Resting systolic blood pressure of 160 mmHg or more or resting diastolic bloodpressure of 100 mmHg or more. If medicated for blood pressure control, themedication 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 apsychological condition within the past 12 months, or not being on a stable dose oftreatment for at least 6 months.
Report plans to relocate to a location not accessible to the study site or havingemployment, personal, or travel commitments that prohibit attendance at scheduledintervention sessions or assessments.

Study Design