Comparision of Aerobic Exercise to Aerobic Plus Yoga Exercise for Weight Loss in Adults With Overweight or Obesity.
- Conditions
- Obesity and Overweight
- Registration Number
- NCT06636773
- Lead Sponsor
- University of Kansas Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 290
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Body Weight 0, 3, 6, 9, 12 months Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
- Secondary Outcome Measures
Name Time Method Weight Loss Strategies 0, 3, 6, 9, 12 months Weight Loss Strategies will be measured using the Eating Behavior Inventory that includes 26 items with each measured on a 5-point scale. A higher score represents engaging in more weight loss strategies.
Mood/Affect 0, 3, 6, 9, 12 months The Positive and Negative Affect Schedule (PANAS) will be used to assess mood/affect which includes 20 items measured on a 5-point scale. A higher score represents a higher degree of either positive or negative affect.
Perceived Stress 0, 3, 6, 9, 12 months Perceived Stress Scale (PSS) will assess a global appraisal of perceived stress, which includes 10 items each score on a 5-point scale. A higher score represents higher perceived stress.
Depressive Symptoms 0, 3, 6, 9, 12 months Centers for Epidemiological Studies Depression Scale (CES-D) will assess depressive symptoms. This includes 10 items scored on a scale of 0-4, with a higher score representing higher depressive symptoms.
Mindfulness 0, 3, 6, 9, 12 months The Mindful Attention Awareness Scale is used to measure mindfulness. It contains 15 items scored on a 1-6 scale, and a higher score represents more mindfulness.
Mindfulness Practice 0, 3, 6, 9, 12 months The Five-Facet Mindfulness Questionnaire will be used to assess mindfulness and mindfulness practice. It contains 39 items scored on a 5-point scale, and a higher score represents more mindfulness practice.
Sleep 0, 3, 6, 9, 12 months Sleep will be assessed using the Pittsburgh Sleep Quality Index. The sum of 7 domains, each scored on a 0-3 scales, provide a total score that ranges from 0-21. A higher score indicates greater sleep disturbance.
Acute Physical Activity Test - perceived distress Between weeks 2-6, at 6 months, at 12 months Perceived distress will be measured using a questionnaire that includes 12 items scored on a 7-point scale.
Waist Circumference 0, 6, 12 months Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed.
Cardiorespiratory Fitness 0, 6, 12 months Cardiorespiratory fitness will be the duration measured in minutes to achieve 85% of age-predicted maximal heart rate during a submaximal graded exercise test performed on a treadmill.
Energy Intake (Dietary Intake) 0, 3, 6, 9, 12 months Energy Intake (Dietary Intake) expressed as kilocalories eaten per day (kcal/day) will be measured using the Diet History Questionnaire (DHQ) developed by NCI. A higher score represents more calories eaten.
Dietary Cognitive Restraint 0, 3, 6, 9, 12 months Dietary cognitive restraint will be measured using from 21 items on the 3-Factor Eating Questionnaire. The range of possible scores is 0 to 20, with a higher score representing high dietary cognitive restraint.
Dietary Disinhibition 0, 3, 6, 9, 12 months Dietary disinhibition will be measured using from 16 items on the 3-Factor Eating Questionnaire. The range of possible scores is 0 to 16, with a higher score representing high dietary disinhibition.
Hunger 0, 3, 6, 9, 12 months Hunger will be measured using from 15 items on the 3-Factor Eating Questionnaire. The range of possible scores is 0 to 15, with a higher score representing high hunger.
Lean Body Mass 0, 6, 12 months Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Bone mineral content 0, 6, 12 months Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Body Mass Index 0, 3, 6, 9, 12 months Measurements of weight and height will be used to compute BMI (kg/m2).
Percent body fat 0, 6, 12 months Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Body Fat Mass 0, 6, 12 months Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA).
Acute Physical Activity Test - Mood Between weeks 2-6, at 6 months, at 12 months Mood will be measured using a questionnaire. The Positive and Negative Affect Schedule (PANAS) will be used to assess mood/affect which includes 20 items measured on a 5-point scale. A higher score represents a higher degree of either positive or negative affect.
Acute Physical Activity Test - Sleepiness Between weeks 2-6, at 6 months, at 12 months Sleepiness will be measured using on a 9-point scale with a higher score representing more sleepiness.
Acute Physical Activity Test - Hunger Between weeks 2-6, at 6 months, at 12 months Hunger will be measured using a 100 mm visual analog scale, with a higher score representing more hunger.
Acute Physical Activity Test - Cortisol Between weeks 2-6, at 6 months, at 12 months Cortisol will be measured from a blood sample using a commercially available assay.
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States