Effectiveness of the Addition of Yoga to a Behavioral Weight Loss Intervention for Adults With Overweight or Obesity (MOVE for Health)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/m
- •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.
排除标准
- •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.
研究组 & 干预措施
Behavioral Weight Loss Plus Aerobic Physical Activity
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.
干预措施: Diet (Behavioral)
Behavioral Weight Loss Plus Aerobic Physical Activity
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.
干预措施: Aerobic Exercise (Behavioral)
Behavioral Weight Loss Plus Aerobic Physical Activity
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.
干预措施: Behavioral Sessions (Behavioral)
Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga
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.
干预措施: Diet (Behavioral)
Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga
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.
干预措施: Behavioral Sessions (Behavioral)
Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga
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.
干预措施: Aerobic + Yoga Exercise (Behavioral)
结局指标
主要结局
Body Weight
时间窗: 0, 3, 6, 9, 12 months
Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg.
次要结局
- Body Mass Index(0, 3, 6, 9, 12 months)
- Percent body fat(0, 6, 12 months)
- Body Fat Mass(0, 6, 12 months)
- Lean Body Mass(0, 6, 12 months)
- Bone mineral content(0, 6, 12 months)
- Waist Circumference(0, 6, 12 months)
- Energy Intake (Dietary Intake)(0, 3, 6, 9, 12 months)
- Dietary Cognitive Restraint(0, 3, 6, 9, 12 months)
- Dietary Disinhibition(0, 3, 6, 9, 12 months)
- Hunger(0, 3, 6, 9, 12 months)
- Mood/Affect(0, 3, 6, 9, 12 months)
- Perceived Stress(0, 3, 6, 9, 12 months)
- Depressive Symptoms(0, 3, 6, 9, 12 months)
- Mindfulness(0, 3, 6, 9, 12 months)
- Mindfulness Practice(0, 3, 6, 9, 12 months)
- Sleep(0, 3, 6, 9, 12 months)
- Acute Physical Activity Test - perceived distress(Between weeks 2-6, at 6 months, at 12 months)
- Acute Physical Activity Test - Mood(Between weeks 2-6, at 6 months, at 12 months)
- Acute Physical Activity Test - Sleepiness(Between weeks 2-6, at 6 months, at 12 months)
- Acute Physical Activity Test - Hunger(Between weeks 2-6, at 6 months, at 12 months)
- Acute Physical Activity Test - Cortisol(Between weeks 2-6, at 6 months, at 12 months)
- Cardiorespiratory Fitness(0, 6, 12 months)
- Weight Loss Strategies(0, 3, 6, 9, 12 months)
研究者
John M. Jakicic, PhD
Professor
University of Kansas Medical Center