ClinicalTrials.gg
CompletedNCT03459937Updated Nov 27, 2020

Integration of Yoga for the Treatment of Obesity in Adults

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

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

Read the detailed description

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:

  • Vinyasa yoga will be integrated into the Standard Behavioral Weight Loss Intervention. This will require refinement of the Vinyasa yoga intervention to assure that this is appropriate for adults with obesity and to develop the necessary Vinyasa yoga intervention materials.
  • The feasibility of randomizing and retaining participants within the context of a Standard Behavioral Weight Loss Intervention that also includes either a restorative Hatha style of yoga or Vinyasa style of yoga will be examined.
  • The fidelity and compliance to the yoga components of the intervention will be examined.

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:

  • Height and Weight
  • Resting Blood Pressure and Heart Rate
  • Cardiorespiratory Fitness
  • Anthropometric Measures (girth of waist and hips)
  • Physical Activity
  • Dietary Intake
  • Additional Questionnaires to assess demographics, physical activity barriers, eating behaviors, sedentary behavior, physical activity self-efficacy, mindfulness, psychological flexibility and self-regulation, affect, perceived stress, anxiety, sleep, depressive symptoms, and treatment satisfaction.

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.

02

Conditions studied

  • Obesity
  • Physical Activity
  • Weight Loss
  • Weight Change, Body

Keywords

  • obesity
  • yoga
  • mindfulness
  • weight loss
  • physical activity
03

In context

Obesity

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • Both males and females of all race/ethnic groups are eligible for participation in this study.
  • 18-60 years of age.
  • (BMI) between 25.0 to \<40.0 kg/m2.
  • Ability to provide 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

Exclusion Criteria:

  • Report moderate-to-vigorous exercise on >3 days per week or a total of >60 minutes per week over the past 3 months.
  • Engaging in any style of yoga on an average of at least 1 day per week over the past 3 months.
  • Report weight loss of >3% or participating in a weight reduction diet in the past 3 months.
  • Females who are pregnant or breastfeeding, or reporting a planned pregnancy during the study period.
  • History of bariatric surgery.
  • Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; cancer; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
  • 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 resting diastolic blood pressure of >100 mmHg.
  • Eating disorders that would contraindicate weight loss or physical activity.
  • Alcohol or substance abuse.
  • Currently treated for psychological issues (i.e., depression, bipolar disorder, etc.), taking psychotropic medications within the previous 12 months, or hospitalized for depression within the previous 5 years.
  • 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.
  • Physical activity or weight loss deemed to be based on response to the cardiorespiratory fitness test that will be conducted as part of the screening procedures.
Terms in these criteria, in plain language(3)

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.

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.

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.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Hatha Yoga Intervention

    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

  • Experimental
    Vinyasa 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

Interventions

  • BehavioralHatha 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.

  • BehavioralVinyasa Yoga Intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Other outcomes

  1. Weight

    Body weight will be assessed in kilograms

    Time frame: Change at 6 months

  2. Height

    Height will be measured in centimeters

    Time frame: Change at 6 months

  3. Body Mass Index (BMI)

    measures of weight and height will be combined to report BMI in kg/m2

    Time frame: Change at 6 months

  4. Cardiorespiratory Fitness

    Cardiorespiratory fitness will be measured using a submaximal graded exercise test.

    Time frame: Change at 6 months

  5. Physical Activity Counts

    Physical activity counts will be assessed using actigraphy.

    Time frame: Change at 6 months

  6. Physical Activity minutes

    Physical activity minutes will be assessed using questionnaires.

    Time frame: Change at 6 months

  7. Physical Activity Energy Expenditure

    Physical activity energy expenditure (kcal/week) will be assessed using questionnaires.

    Time frame: Change at 6 months

  8. Dietary Intake

    Dietary intake (kcal/day) will be measured using a food frequency questionnaire

    Time frame: Change at 6 months

  9. Sedentary Behavior Duration

    Sedentary behavior duration (minutes) will be assessed using questionnaires

    Time frame: Change at 6 months

  10. Sedentary Behavior Counts

    Sedentary behavior will be assessed from counts using actigraphy

    Time frame: Change at 6 months

  11. Physical activity barriers

    Physical activity barriers will be assessed with a questionnaire

    Time frame: Change at 6 months

  12. Eating behaviors

    Eating behaviors will be assessed with questionnaires

    Time frame: Change at 6 months

  13. Mindfulness

    Mindfulness will be assessed with questionnaires

    Time frame: Change at 6 months

  14. Psychological flexibility

    Psychological flexibility will be assessed with questionnaires

    Time frame: Change at 6 months

  15. Self-regulation

    Self-regulation will be assessed with questionnaires

    Time frame: Change at 6 months

  16. Affect

    Affect will be assessed with a questionnaire

    Time frame: Change at 6 months

  17. Depressive symptoms

    Depressive symptoms will be assessed with questionnaires

    Time frame: Change at 6 months

  18. Anxiety

    Anxiety will be assessed with questionnaires

    Time frame: Change at 6 months

  19. Sleep time

    Sleep time will be assessed with a questionnaire

    Time frame: Change at 6 months

  20. Sleep quality

    Sleep quality will be assessed with a questionnaire

    Time frame: Change at 6 months

  21. Sleep duration

    Sleep duration will be assessed with counts from actigraphy

    Time frame: Change at 6 months

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15260, United States
08

References and documents

Publications

  • 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. PubMed 33528905 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Feb 26, 2018
First posted
Mar 9, 2018
StartActual
Apr 25, 2018
Primary completionActual
Dec 31, 2018
CompletionActual
Dec 31, 2018
Last update
Nov 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03459937
Responsible party
John M. Jakicic, PhD (Professor, University of Pittsburgh) — Principal investigator
First posted
Mar 9, 2018
Start date
Apr 25, 2018
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Nov 27, 2020

Study contacts

John M Jakicic, PhD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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