About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Diet
BehavioralA reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants.
Aerobic Exercise
BehavioralPhysical 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 Sessions
BehavioralParticipants 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.
Aerobic + Yoga Exercise
BehavioralPhysical 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.
Treatment groups
Trial outcomes
Primary outcomes
Body Weight
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
Secondary outcomes
Body Mass Index
Measurements of weight and height will be used to compute BMI (kg/m2).
Percent body fat
Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Body Fat Mass
Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Lean Body Mass
Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Other outcomes
Medication History
A questionnaire developed specifically for this study will be used to assessment medication history. The data collected include the type of medication, dose of medication, and frequency that the medication is taken, and what condition the medication is indicated to treat.
Lifestyle and Health History
A questionnaire developed specifically for this study that is conducted as an interview will be used to assess lifestyle and health factors to describe the sample for this study. The score is either "yes" or "no" identifying the presences of a lifestyle or health factor.
Adverse and Serious Adverse Events
Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events.
Sponsors and contacts
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University of Kansas Medical Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator