An interventional study of Hatha Yoga Intervention and Vinyasa Yoga Intervention in Obesity, Physical Activity and Weight Loss, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-27.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 50 is below the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This intervention will be a behavioral weight loss intervention that includes group intervention session, prescribed dietary recommendations, and inclusion of Hatha Yoga.
Behavioral: Hatha Yoga Intervention
This intervention will be a behavioral weight loss intervention that includes group intervention session, prescribed dietary recommendations, and inclusion of Vinyasa Yoga.
Behavioral: Vinyasa Yoga Intervention
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.
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.
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
Time frame: 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
Time frame: Across the 6 month intervention period
Weight
Body weight will be assessed in kilograms
Time frame: Change at 6 months
Height
Height will be measured in centimeters
Time frame: Change at 6 months
Body Mass Index (BMI)
measures of weight and height will be combined to report BMI in kg/m2
Time frame: Change at 6 months
Cardiorespiratory Fitness
Cardiorespiratory fitness will be measured using a submaximal graded exercise test.
Time frame: Change at 6 months
Physical Activity Counts
Physical activity counts will be assessed using actigraphy.
Time frame: Change at 6 months
Physical Activity minutes
Physical activity minutes will be assessed using questionnaires.
Time frame: Change at 6 months
Physical Activity Energy Expenditure
Physical activity energy expenditure (kcal/week) will be assessed using questionnaires.
Time frame: Change at 6 months
Dietary Intake
Dietary intake (kcal/day) will be measured using a food frequency questionnaire
Time frame: Change at 6 months
Sedentary Behavior Duration
Sedentary behavior duration (minutes) will be assessed using questionnaires
Time frame: Change at 6 months
Sedentary Behavior Counts
Sedentary behavior will be assessed from counts using actigraphy
Time frame: Change at 6 months
Physical activity barriers
Physical activity barriers will be assessed with a questionnaire
Time frame: Change at 6 months
Eating behaviors
Eating behaviors will be assessed with questionnaires
Time frame: Change at 6 months
Mindfulness
Mindfulness will be assessed with questionnaires
Time frame: Change at 6 months
Psychological flexibility
Psychological flexibility will be assessed with questionnaires
Time frame: Change at 6 months
Self-regulation
Self-regulation will be assessed with questionnaires
Time frame: Change at 6 months
Affect
Affect will be assessed with a questionnaire
Time frame: Change at 6 months
Depressive symptoms
Depressive symptoms will be assessed with questionnaires
Time frame: Change at 6 months
Anxiety
Anxiety will be assessed with questionnaires
Time frame: Change at 6 months
Sleep time
Sleep time will be assessed with a questionnaire
Time frame: Change at 6 months
Sleep quality
Sleep quality will be assessed with a questionnaire
Time frame: Change at 6 months
Sleep duration
Sleep duration will be assessed with counts from actigraphy
Time frame: Change at 6 months
Plan to share: No
Ran from Apr 2018 to primary completion in Dec 2018, 8 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 8 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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