Obesity and Overweight
Conditions
Keywords
obesity, overweight, exercise, physical activity, yoga, weight loss
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.
Interventions
BEHAVIORALDiet
A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants.
BEHAVIORALAerobic Exercise
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.
BEHAVIORALBehavioral Sessions
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 to assist in supporting recommended changes in energy intake (diet) and physical activity.
BEHAVIORALAerobic + Yoga Exercise
Physical 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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). |
| 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 represented as milliliters of oxygen consumed per kilogram of body weight per minute (ml/kg/min) measured with a metabolic cart during a submaximal graded exercise test that is terminated when the participant achieves 85% of age-predicted maximal heart rate. |
| 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. |
| 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. |
| Weight Loss Strategies | 0, 3, 6, 9, 12 months | Weight Loss Strategies will be measured using the Weight Control Strategies Scale that includes 30 items. A higher score represents engaging in more weight control 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse and Serious Adverse Events | 0, 3, 6, 9, 12 months and at other times when reported by the participant | Participants will be queried using a survey developed specifically for this study will be used to assess for adverse events and serious adverse events. |
| Medication History | 0, 3, 6, 9, 12 months | 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 | 0 months (prior to randomization) | 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. |
Countries
United States
Contacts
Primary ContactJohn M Jakicic, PhD
Outcome results
None listed