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

University of Kansas

Status: Enrolling

Conditions: Obesity and Overweight

Treatments: Behavioral: Aerobic Exercise; Behavioral: Aerobic + Yoga Exercise; Behavioral: Diet; Behavioral: Behavioral Sessions

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06636773

R01DK135735-01A1 (U.S. NIH Grant/Contract)

STUDY00160080

Details and patient eligibility

About

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.

Enrollment: 290 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 >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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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290 participants in 2 patient groups

Behavioral Weight Loss Plus Aerobic Physical Activity

Experimental group

Description:

The 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.

Treatment:

Behavioral: Behavioral Sessions

Behavioral: Diet

Behavioral: Aerobic Exercise

Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga

Experimental group

Description:

The 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.

Treatment:

Behavioral: Behavioral Sessions

Behavioral: Aerobic + Yoga Exercise

Behavioral: Diet