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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009361 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss Intervention, and to use this information to inform an expanded study to directly test the effectiveness of these interventions on weight loss in adults.
The focus of this study is to examine the feasibility of integrating Vinyasa yoga into a Standard Behavioral Weight Loss Intervention, to examine whether engagement differs between Vinyasa yoga and a restorative form of Hatha yoga within a Standard Behavioral Weight Loss Intervention, and to use this information to inform an expanded study to directly test the effectiveness of these interventions on weight loss in adults. Thus, study will pursing the following aims:
To examine the aims listed above potential participants will be recruited through a variety of advertisement methods. Those individuals responding to these advertisements will have the study explained to them and informed consent will be obtained. These participants will complete a series of screening assessments that will be used to determine eligibility (height and weight to determine body mass index, resting blood pressure, heart rate, cardiorespiratory fitness). For participants deemed to be eligible and randomized to participate in this study, these measures will also be used as their baseline data from analysis. Additional data collection will be collected at the baseline assessment visit, with assessments repeated following the 6 month intervention. Assessments will include the following:
Assessments will be completed at both baseline and following the 6-month intervention. Moreover, following the intervention, participants will engage in group-based qualitative interviews. These qualitative interviews will focus on better understanding strengths, weaknesses, and barriers to engagement in the intervention that was used in this study. This information will be used to refine our approach prior to pursuing additional studies in this areas of research.
This study involves a 6 month behavioral weight loss intervention (SBWI) with participants randomized to either Hatha Yoga or Vinyasa Yoga as the form of physical activity. All randomized participant will received the components of the SBWI along with either Hatha Yoga or Vinyasa Yoga based on their randomized intervention assignment. Participants will attend weekly group meetings for all weeks of the study. Group meetings will last approximately 30-45 minutes in duration and will be led by trained behavioral interventionists with previous experience facilitating behavioral weight loss intervention meetings. These meetings will focus on strategies to promote behavior change and weight management. Strategies to promote behavior change will included the Social Cognitive Theory, Problem Solving Theory, and Relapse Prevention. Participants will be weighed weekly prior to group meetings to track changes in weight throughout the study and assist interventionists with weight counseling. Participants who do not attend the weekly group meeting will be contacted via telephone call to reschedule for an individual weigh-in and make-up session with an interventionist prior to the next group meeting. If an individual make-up session cannot be scheduled, an interventionist will provide a brief counseling session by telephone and the written materials will be mailed to the participant.
Dietary recommendations within the intervention will be based on the participants' baseline body weight. These calorie goals are based on intake recommendations that have been successful in other weight loss programs, and fat intake goals are consistent with the USDA Dietary Guidelines. Participants weighing less than 200 pounds will be prescribed a 1200 kcal/day diet, participants weighing between 200 to less than 250 will be prescribed 1500 kcal/day, and participants weighing 250 or more will be prescribed 1800 kcal/day. To promote adoption and adherence to these recommendations, participants will be provided self-monitoring paper diaries, meal plans, and sample recipes. Participants will be instructed to self-monitor daily and will be instructed to turn in self-monitoring food diaries to their interventionist prior to group intervention meetings. Printed intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals.
Physical Activity Components of the Intervention:
Hatha Yoga Group: The specific description of physical activity for those randomized to receive Hatha Yoga will focus on a restorative style of Hatha yoga. This will involve a systematic progression to allow for participants to acclimate to the poses and this style of yoga practice. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). Participants will be instructed to spread this dose of activity equally across 5 days each week, with each session starting at 20 minutes and progressing to 50 minutes. The initial 1-2 weeks will focus on the participants understanding the asanas (or poses) and gaining kinesthetic awareness of their body while moving through the movement sequences. Study participants will be provided with a yoga mat to use throughout the study, and they will be permitted to keep this yoga mat at the conclusion of their participation in this study.
While attending the SBWI group session the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, yoga videos that we develop that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions will be provided, and these videos will be led by the same individual who is instructing the supervised yoga sessions. To facilitate the use of these yoga videos by participants, access will be provided by loading them on to a tablet (iPad, Surface, etc.) that will be provided to the participant or through other electronic formats (YouTube Channel, streaming through study website, etc.). The sequence of videos will be scheduled to be accessible to the participant on predetermined dates that coincide with the progression of the yoga activities in the intervention.
Vinyasa Yoga Group: The specific description of physical activity for those randomized to receive Vinyasa Yoga will focus on a more vigorous form of yoga. This will involve a systematic progression to allow for participants to acclimate to the poses and this style of yoga practice. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). Participants will be instructed to spread this dose of activity equally across 5 days each week, with each session starting at 20 minutes and progressing to 50 minutes. The initial 1-2 weeks will focus on the participants understanding the asanas (or poses) and gaining kinesthetic awareness of their body while moving through the movement sequences. Study participants will be provided with a yoga mat to use throughout the study, and they will be permitted to keep this yoga mat at the conclusion of their participation in this study.
While attending the SBWI group session the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, yoga videos that we develop that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions will be provided, and these videos will be led by the same individual who is instructing the supervised yoga sessions. To facilitate the use of these yoga videos by participants, access will be provided by loading them on to a tablet (iPad, Surface, etc.) that will be provided to the participant or through other electronic formats (YouTube Channel, streaming through study website, etc.). The sequence of videos will be scheduled to be accessible to the participant on predetermined dates that coincide with the progression of the yoga activities in the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hatha Yoga Intervention | Experimental | This intervention will be a behavioral weight loss intervention that includes group intervention session, prescribed dietary recommendations, and inclusion of Hatha Yoga. |
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| Vinyasa Yoga Intervention | Experimental | This intervention will be a behavioral weight loss intervention that includes group intervention session, prescribed dietary recommendations, and inclusion of Vinyasa Yoga. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hatha Yoga Intervention | Behavioral | Hatha Yoga will focus on a restorative style of Hatha yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period. |
| Measure | Description | Time Frame |
|---|---|---|
| Fidelity to the yoga interventions | Fidelity will be based on the number of days that yoga was performed during the intervention compared to the prescribed number of days that yoga was to be completed in both the Hatha Yoga Group and the Vinyasa Yoga Group | Across the 6 month intervention period |
| Compliance to the yoga interventions | Compliance will be based on the number of days that the yoga was completed at the prescribed duration compared to the prescribed number of days that yoga was to be completed in both the Hatha Yoga Group and the Vinyasa Yoga Group | Across the 6 month intervention period |
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| Measure | Description | Time Frame |
|---|---|---|
| Weight | Body weight will be assessed in kilograms | Change at 6 months |
| Height | Height will be measured in centimeters | Change at 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M Jakicic, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33528905 | Derived | Jakicic JM, Davis KK, Rogers RJ, Sherman SA, Barr S, Marcin ML, Collins KA, Collins AM, Yuan N, Lang W. Feasibility of Integration of Yoga in a Behavioral Weight-Loss Intervention: A Randomized Trial. Obesity (Silver Spring). 2021 Mar;29(3):512-520. doi: 10.1002/oby.23089. Epub 2021 Feb 2. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009043 | Motor Activity |
| D015431 | Weight Loss |
| D001836 | Body Weight Changes |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Participants will be randomly assigned to one of two intervention conditions, with assessments occurring at pre-intervention and post-intervention.
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Outcomes assessors will be masked to intervention condition. Selected investigators who are overseeing the intervention will also be masked to study outcomes.
|
| Vinyasa Yoga Intervention | Behavioral | Vinyasa Yoga will focus on a more vigorous form of yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period. |
|
| Body Mass Index (BMI) | measures of weight and height will be combined to report BMI in kg/m2 | Change at 6 months |
| Cardiorespiratory Fitness | Cardiorespiratory fitness will be measured using a submaximal graded exercise test. | Change at 6 months |
| Physical Activity Counts | Physical activity counts will be assessed using actigraphy. | Change at 6 months |
| Physical Activity minutes | Physical activity minutes will be assessed using questionnaires. | Change at 6 months |
| Physical Activity Energy Expenditure | Physical activity energy expenditure (kcal/week) will be assessed using questionnaires. | Change at 6 months |
| Dietary Intake | Dietary intake (kcal/day) will be measured using a food frequency questionnaire | Change at 6 months |
| Sedentary Behavior Duration | Sedentary behavior duration (minutes) will be assessed using questionnaires | Change at 6 months |
| Sedentary Behavior Counts | Sedentary behavior will be assessed from counts using actigraphy | Change at 6 months |
| Physical activity barriers | Physical activity barriers will be assessed with a questionnaire | Change at 6 months |
| Eating behaviors | Eating behaviors will be assessed with questionnaires | Change at 6 months |
| Mindfulness | Mindfulness will be assessed with questionnaires | Change at 6 months |
| Psychological flexibility | Psychological flexibility will be assessed with questionnaires | Change at 6 months |
| Self-regulation | Self-regulation will be assessed with questionnaires | Change at 6 months |
| Affect | Affect will be assessed with a questionnaire | Change at 6 months |
| Depressive symptoms | Depressive symptoms will be assessed with questionnaires | Change at 6 months |
| Anxiety | Anxiety will be assessed with questionnaires | Change at 6 months |
| Sleep time | Sleep time will be assessed with a questionnaire | Change at 6 months |
| Sleep quality | Sleep quality will be assessed with a questionnaire | Change at 6 months |
| Sleep duration | Sleep duration will be assessed with counts from actigraphy | Change at 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |