YogaSYNERGYNCT05031221
Feasibility and Impact of Yoga in Obesity
A study testing Yoga + behavioral weight loss in people with Yoga and Obesity, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Yoga may confer health benefits in people with overweight or obesity that enhance weight loss and weight loss maintenance. This study aims to investigate the feasibility of integrating yoga into an established behavioral weight loss program and describe the effects on glucose control, appetite, dietary intake… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Yoga, Obesity, Weight Loss
- What is being tested?
- Yoga + behavioral weight loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 15 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults age 18-55
- Body mass index (BMI) 27-45 kg/m2
- Live or work within 30 miles of the University of Colorado Anschutz Health and Wellness Center
- Passing medical and physical screening
- Agree to fast for 12 hours before the baseline and follow-up visits
- Sedentary: defined as <150 minutes per week of voluntary exercise at moderate intensity or greater and < 60 min per day of total habitual PA (i.e. work related, transportation related) at moderate intensity or greater, over the past 3 months.
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- Not currently practicing yoga regularly over past 6 months
- Among women: Not currently pregnant or lactating, not planning to become pregnant in the next 12 weeks
- English speaking, as the intervention will be delivered in English
Who cannot join
- Diastolic blood pressure > 100 mm HG or systolic blood pressure > 160 mm HG
- Resting heart rate >100
- Diabetes (fasting glucose ≥126 mg/dL or Hemoglobin A1C ≥6.5%)
- Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range) or history of uncontrolled thyroid disorder.
- Abnormal values of: hematocrit, white blood cell count or platelets
- Triglycerides > 400 mg/dL
Show all 24Show fewer
- LDL cholesterol >200 mg/dL
- Abnormal resting electrocardiogram (ECG)
- Presence or history of any self-reported metabolic or chronic health problems which would affect appetite, food intake, energy metabolism, or ability to optimally participate in the exercise component
- Significant self-reported pulmonary disorders including: chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, or uncontrolled asthma.
- Self-reported symptoms suggestive of CVD: chest pain, shortness of breath at rest or with mild exertion, syncope.
- Regular use of prescription or over-the-counter medications known to significantly impact appetite, weight, or energy metabolism
- Regular use of systemic steroids (other than Oral Contraceptive Pills).
- Regular use of obesity pharmacotherapeutic agents within the last 6 months.
- Previous obesity treatment with surgery or weight loss device
- Current alcohol or substance abuse
- Nicotine use (past 6 months)
- History of clinically diagnosed eating disorders including anorexia nervosa, bulimia, binge eating disorder.
- Current severe depression or history of severe depression within the previous year
- History of other significant psychiatric illness (e.g. psychosis, schizophrenia, mania, bipolar disorder) which in the opinion of the Study MD would interfere with ability to adhere to dietary or exercise interventions.
- Currently participating in or planning to participate in any formal weight loss or physical activity programs or clinical trials.
- Participation in a weight loss program using the Colorado Weigh curriculum within the past 3 years
- Weight loss >5kg in past 3 months for any reason except post-partum weight loss
- Weight loss of >50 lbs in past 3 years for any reason except post-partum weight loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: A Proof-of-Concept Study Examining the Addition of Yoga to a Behavioral Weight Loss Intervention on Energy Balance and Health-Related Outcomes
Yoga may confer health benefits in people with overweight or obesity that enhance weight loss and weight loss maintenance. This study aims to investigate the feasibility of integrating yoga into an established behavioral weight loss program and describe the effects on glucose control, appetite, dietary intake, physical activity, and psychological health.
Read the detailed description
Innovative approaches to improve long-term behavioral weight loss (BWL) program outcomes are critically needed. Current BWL programs typically produce modest (~5-10%) short-term (~6 month) weight loss, but substantial weight regain by 1-year is common and well-documented. There has been a growing interest in examining the effects of yoga on weight loss and cardio-metabolic disease risk among adults with overweight, obesity, metabolic syndrome, pre-diabetes, and diabetes. Overall, results are somewhat promising, but reviews and meta-analyses all conclude that existing studies suffer from significant methodological shortcomings. Moreover, yoga is broadly, variably, and often incorrectly defined, reflecting how key aspects of traditional yoga practice, with specific mind, body, and breath-based practices were lost in translation when yoga was commercially adopted as a form of exercise in the West. These key aspects warrant inclusion in yoga intervention research.
The overall objectives of the proposed research are to 1) Evaluate the feasibility and acceptability of adding a 12-week traditional, multi-component yoga program to a standard BWL intervention (BWL+yoga), and 2) Explore changes in clinical/cardiometabolic, psychological, and energy balance/behavioral measures relevant for reducing cardio-metabolic disease risk. The yoga intervention was developed in collaboration with a world-renowned expert in traditional yoga practices following three decades of dedicated study, practice, and teaching (Mr. Paul Dallaghan). The program includes specific postures (asana), breathing (pranayama), and meditation (inner focus) techniques performed with an underlying focus on self-awareness delivered in-person and virtually. These specific techniques have been practiced historically and described for their benefits in the original Sanskrit teachings but are often excluded from yoga programs developed in the West. The overarching hypotheses are that these specific Hatha (body-breath) and Pantanjala (mind) yoga practices will be feasible in the context of a BWL, will support the adoption of changes in diet and physical activity, and improve mental and physical health.
- Conditions
- Yoga, Obesity, Weight Loss
- Being tested
- Yoga + behavioral weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga + behavioral weight lossBehavioural
A 12-week, one-arm proof-of-concept and feasibility study will be conducted at the University of Colorado Anschutz Medical Campus (CU-AMC) to assess the processes critical for the success of future randomized trials including: a) Evaluating the feasibility and acceptability of adding a multi-component yoga program to a standard BWL intervention and b) Examining pre-post changes in relevant clinical/cardiometabolic, psychological, and energy balance/behavioral outcomes to inform the design of future trials. Participants will receive a comprehensive, group-based BWL intervention consistent with current guidelines for obesity treatment and a carefully designed multi-component yoga intervention delivered through pre-recorded videos delivered through a cloud-based platform that will be completed in-person and at-home (BWL+yoga).
| Study group | Role | What they receive |
|---|---|---|
| Yoga + behavioral weight loss | Experimental | In person and virtual yoga + 150 minutes of moderate-to-vigorous physical activity/week + weekly instruction on dietary strategies for weight loss Receives: Behavioral: Yoga + behavioral weight loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment
Ability to enroll 12-20 participants
Measured: 12 weeks before intervention initiation
Retention
Attrition >20%
Measured: At intervention completion (12 weeks)
Collection of secondary outcome measures at baseline
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Measured: Baseline (week 0)
Collection of secondary outcome measures at follow-up
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Measured: Intervention completion (12 weeks)
Acceptability during the intervention
Participant satisfaction with the intervention on a 1-10 Likert scale
Measured: Week 6
Acceptability after the intervention
Participant satisfaction with the intervention on a 1-10 Likert scale
Measured: Week 12
Adherence
Percent completion of intervention sessions
Measured: Weekly during the 12 week intervention
Adverse events (intervention safety)
Study-related adverse events
Measured: Weekly during the 12-week intervention
Secondary outcomes (6)
Body weight change
Body weight in kg
Measured: Week 0 and 12
Resting metabolic rate (RMR) change
RMR in kcal/day
Measured: Week 0 and 12
Body composition change
Fat mass and fat-free mass as measured by dual X-ray absorptiometry
Measured: Week 0 and 12
Glucose tolerance change
2-hour oral glucose tolerance
Measured: Week 0 and 12
Cardiometabolic health change
As measured by cholesterol, triglycerides, high- and low-density lipoproteins
Measured: Week 0 and 12
Heart rate variability change
As measured by a 12-minute sit to stand protocol with heart rate monitor
Measured: Week 0 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start2 Aug 2021
- Primary completion15 Aug 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof-of-Concept, single-arm study
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann E Caldwell, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031221
- Sponsor's protocol ID
- 21-3690
- Acronym
- SYNERGY
- Status last verified
- Dec 2022
- First submitted
- 29 Jul 2021
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-Concept Study Examining the Addition of Yoga to a Behavioral Weight Loss Intervention on Energy Balance and Health-Related Outcomes
- ClinicalTrials.gov ID
- NCT05031221
- Acronym / sponsor ID
- SYNERGY / 21-3690
- Conditions
- Yoga, Obesity, Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Yoga may confer health benefits in people with overweight or obesity that enhance weight loss and weight loss maintenance. This study aims to investigate the feasibility of integrating yoga into an established behavioral weight loss program and describe the effects on glucose control, appetite, dietary intake, physical activity, and psychological health.
Detailed description
Innovative approaches to improve long-term behavioral weight loss (BWL) program outcomes are critically needed. Current BWL programs typically produce modest (~5-10%) short-term (~6 month) weight loss, but substantial weight regain by 1-year is common and well-documented. There has been a growing interest in examining the effects of yoga on weight loss and cardio-metabolic disease risk among adults with overweight, obesity, metabolic syndrome, pre-diabetes, and diabetes. Overall, results are somewhat promising, but reviews and meta-analyses all conclude that existing studies suffer from significant methodological shortcomings. Moreover, yoga is broadly, variably, and often incorrectly defined, reflecting how key aspects of traditional yoga practice, with specific mind, body, and breath-based practices were lost in translation when yoga was commercially adopted as a form of exercise in the West. These key aspects warrant inclusion in yoga intervention research.
The overall objectives of the proposed research are to 1) Evaluate the feasibility and acceptability of adding a 12-week traditional, multi-component yoga program to a standard BWL intervention (BWL+yoga), and 2) Explore changes in clinical/cardiometabolic, psychological, and energy balance/behavioral measures relevant for reducing cardio-metabolic disease risk. The yoga intervention was developed in collaboration with a world-renowned expert in traditional yoga practices following three decades of dedicated study, practice, and teaching (Mr. Paul Dallaghan). The program includes specific postures (asana), breathing (pranayama), and meditation (inner focus) techniques performed with an underlying focus on self-awareness delivered in-person and virtually. These specific techniques have been practiced historically and described for their benefits in the original Sanskrit teachings but are often excluded from yoga programs developed in the West. The overarching hypotheses are that these specific Hatha (body-breath) and Pantanjala (mind) yoga practices will be feasible in the context of a BWL, will support the adoption of changes in diet and physical activity, and improve mental and physical health.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof-of-Concept, single-arm study
| Arm | Type | Receives |
|---|---|---|
| Yoga + behavioral weight loss | Experimental | Behavioral: Yoga + behavioral weight lossIn person and virtual yoga + 150 minutes of moderate-to-vigorous physical activity/week + weekly instruction on dietary strategies for weight loss |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Adults age 18-55
- Body mass index (BMI) 27-45 kg/m2
- Live or work within 30 miles of the University of Colorado Anschutz Health and Wellness Center
- Passing medical and physical screening
- Agree to fast for 12 hours before the baseline and follow-up visits
Key exclusion criteria (24 listed)
- Diastolic blood pressure > 100 mm HG or systolic blood pressure > 160 mm HG
- Resting heart rate >100
- Diabetes (fasting glucose ≥126 mg/dL or Hemoglobin A1C ≥6.5%)
- Undiagnosed hypo- or hyper-thyroidism (TSH outside of the normal range) or history of uncontrolled thyroid disorder.
- Abnormal values of: hematocrit, white blood cell count or platelets
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga + behavioral weight lossA 12-week, one-arm proof-of-concept and feasibility study will be conducted at the University of Colorado Anschutz Medical Campus (CU-AMC) to assess the processes critical for the success of future randomized trials including: a) Evaluating the feasibility and acceptability of adding a multi-component yoga program to a standard BWL intervention and b) Examining pre-post changes in relevant clinical/cardiometabolic, psychological, and energy balance/behavioral outcomes to inform the design of future trials. Participants will receive a comprehensive, group-based BWL intervention consistent with current guidelines for obesity treatment and a carefully designed multi-component yoga intervention delivered through pre-recorded videos delivered through a cloud-based platform that will be completed in-person and at-home (BWL+yoga). | Behavioural | Yoga + behavioral weight loss |
Primary outcome
Enrollment
Time frame: 12 weeks before intervention initiation
Ability to enroll 12-20 participants
Retention
Time frame: At intervention completion (12 weeks)
Attrition >20%
Collection of secondary outcome measures at baseline
Time frame: Baseline (week 0)
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Collection of secondary outcome measures at follow-up
Time frame: Intervention completion (12 weeks)
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Acceptability during the intervention
Time frame: Week 6
Participant satisfaction with the intervention on a 1-10 Likert scale
Acceptability after the intervention
Time frame: Week 12
Participant satisfaction with the intervention on a 1-10 Likert scale
Adherence
Time frame: Weekly during the 12 week intervention
Percent completion of intervention sessions
Adverse events (intervention safety)
Time frame: Weekly during the 12-week intervention
Study-related adverse events
6 secondary outcomes
Body weight change
Time frame: Week 0 and 12
Resting metabolic rate (RMR) change
Time frame: Week 0 and 12
Body composition change
Time frame: Week 0 and 12
Glucose tolerance change
Time frame: Week 0 and 12
Cardiometabolic health change
Time frame: Week 0 and 12
Heart rate variability change
Time frame: Week 0 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann E Caldwell, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga + behavioral weight loss in people with Yoga and Obesity, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: 12 weeks before intervention initiation). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.