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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK135735-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Weight Loss Plus Aerobic Physical Activity | Experimental | 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. |
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| Behavioral Weight Loss Plus Aerobic Physical Activity and Yoga | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet | Behavioral | A reduced energy diet ranging from 1200-2100 kilocalories per day will be recommended for participants. |
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| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Body weight will be assessed in duplicate using a calibrated digital scale to the nearest 0.1 kg. | 0, 3, 6, 9, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Measurements of weight and height will be used to compute BMI (kg/m2). | 0, 3, 6, 9, 12 months |
| Percent body fat | Percent body fat will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0, 3, 6, 9, 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John M Jakicic, PhD | Contact | 913-588-9078 | jjakicic@kumc.edu |
| Name | Affiliation | Role |
|---|---|---|
| John M. Jakicic, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Recruiting | Kansas City | Kansas | 66160 | United States |
The summary data for each of the study outcomes and other additional demographic characteristics will be made available. The Study Protocol (which includes the statistical analysis plan), Manual of Procedures, Data Collection Forms, and a Data Dictionary to explain the data variables will be provided.
The data will be made available no later than the time of an associated publication of study outcomes or at the end of the performance period, whichever comes first. The data provided to the repository will be available indefinitely while that repository continues to exist.
The information included with the IPD will be made available to appropriate individuals only after the requester confirms their willingness to comply with an appropriate "Data Use Agreement" that complies with NIH policies, the policies of the institution where the study has been conducted, and the elements of informed consent.
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| Aerobic Exercise | Behavioral | 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. |
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| Behavioral Sessions | Behavioral | 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. |
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| Aerobic + Yoga Exercise | Behavioral | 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. |
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| 0, 6, 12 months |
| Body Fat Mass | Body fat mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). | 0, 6, 12 months |
| Lean Body Mass | Lean body mass (kg) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). | 0, 6, 12 months |
| Bone mineral content | Bone mineral content (grams) will be assessed using a total body scan from dual-energy x-ray absorptiometry (DXA). | 0, 6, 12 months |
| Waist Circumference | Circumference measures of the waist taken horizontally at both the iliac crest and the umbilicus will be performed. | 0, 6, 12 months |
| Cardiorespiratory Fitness | 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. | 0, 6, 12 months |
| Cardiorespiratory Fitness | Cardiorespiratory fitness will be represented as total liters of oxygen consumed per minute (L/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. | 0, 6, 12 months |
| Cardiorespiratory Fitness | 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. | 0, 6, 12 months |
| Energy Intake (Dietary Intake) | 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. | 0, 3, 6, 9, 12 months |
| Dietary Cognitive Restraint | 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. | 0, 3, 6, 9, 12 months |
| Dietary Disinhibition | 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. | 0, 3, 6, 9, 12 months |
| Hunger | 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. | 0, 3, 6, 9, 12 months |
| Weight Loss Strategies | 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. | 0, 3, 6, 9, 12 months |
| Weight Loss Strategies | 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. | 0, 3, 6, 9, 12 months |
| Mood/Affect | 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. | 0, 3, 6, 9, 12 months |
| Perceived Stress | 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. | 0, 3, 6, 9, 12 months |
| Depressive Symptoms | 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. | 0, 3, 6, 9, 12 months |
| Mindfulness | 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. | 0, 3, 6, 9, 12 months |
| Mindfulness Practice | 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. | 0, 3, 6, 9, 12 months |
| Sleep | 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. | 0, 3, 6, 9, 12 months |
| Acute Physical Activity Test - perceived distress | Perceived distress will be measured using a questionnaire that includes 12 items scored on a 7-point scale. | Between weeks 2-6, at 6 months, at 12 months |
| Acute Physical Activity Test - Mood | 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. | Between weeks 2-6, at 6 months, at 12 months |
| Acute Physical Activity Test - Sleepiness | Sleepiness will be measured using on a 9-point scale with a higher score representing more sleepiness. | Between weeks 2-6, at 6 months, at 12 months |
| Acute Physical Activity Test - Hunger | Hunger will be measured using a 100 mm visual analog scale, with a higher score representing more hunger. | Between weeks 2-6, at 6 months, at 12 months |
| Acute Physical Activity Test - Cortisol | Cortisol will be measured from a blood sample using a commercially available assay. | Between weeks 2-6, at 6 months, at 12 months |
| 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. |
| 0 months (prior to randomization) |
| 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. | 0, 3, 6, 9, 12 months and at other times when reported by the participant |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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