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Feasibility and Impact of Yoga in Obesity (SYNERGY)

Primary Purpose

Yoga, Obesity, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga + behavioral weight loss
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Yoga

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • University of Colorado - Anschutz Medical Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Yoga + behavioral weight loss

Arm Description

In person and virtual yoga + 150 minutes of moderate-to-vigorous physical activity/week + weekly instruction on dietary strategies for weight loss

Outcomes

Primary Outcome Measures

Enrollment
Ability to enroll 12-20 participants
Retention
Attrition >20%
Collection of secondary outcome measures at baseline
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Collection of secondary outcome measures at follow-up
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Acceptability during the intervention
Participant satisfaction with the intervention on a 1-10 Likert scale
Acceptability after the intervention
Participant satisfaction with the intervention on a 1-10 Likert scale
Adherence
Percent completion of intervention sessions
Adverse events (intervention safety)
Study-related adverse events

Secondary Outcome Measures

Body weight change
Body weight in kg
Resting metabolic rate (RMR) change
RMR in kcal/day
Body composition change
Fat mass and fat-free mass as measured by dual X-ray absorptiometry
Glucose tolerance change
2-hour oral glucose tolerance
Cardiometabolic health change
As measured by cholesterol, triglycerides, high- and low-density lipoproteins
Heart rate variability change
As measured by a 12-minute sit to stand protocol with heart rate monitor

Full Information

First Posted
July 29, 2021
Last Updated
December 20, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT05031221
Brief Title
Feasibility and Impact of Yoga in Obesity
Acronym
SYNERGY
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
August 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Yoga, Obesity, Weight Loss

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Proof-of-Concept, single-arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Yoga + behavioral weight loss
Arm Type
Experimental
Arm Description
In person and virtual yoga + 150 minutes of moderate-to-vigorous physical activity/week + weekly instruction on dietary strategies for weight loss
Intervention Type
Behavioral
Intervention Name(s)
Yoga + behavioral weight loss
Intervention Description
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).
Primary Outcome Measure Information:
Title
Enrollment
Description
Ability to enroll 12-20 participants
Time Frame
12 weeks before intervention initiation
Title
Retention
Description
Attrition >20%
Time Frame
At intervention completion (12 weeks)
Title
Collection of secondary outcome measures at baseline
Description
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Time Frame
Baseline (week 0)
Title
Collection of secondary outcome measures at follow-up
Description
Percent completion of the cardiometabolic, psychological, and energy balance outcome measures
Time Frame
Intervention completion (12 weeks)
Title
Acceptability during the intervention
Description
Participant satisfaction with the intervention on a 1-10 Likert scale
Time Frame
Week 6
Title
Acceptability after the intervention
Description
Participant satisfaction with the intervention on a 1-10 Likert scale
Time Frame
Week 12
Title
Adherence
Description
Percent completion of intervention sessions
Time Frame
Weekly during the 12 week intervention
Title
Adverse events (intervention safety)
Description
Study-related adverse events
Time Frame
Weekly during the 12-week intervention
Secondary Outcome Measure Information:
Title
Body weight change
Description
Body weight in kg
Time Frame
Week 0 and 12
Title
Resting metabolic rate (RMR) change
Description
RMR in kcal/day
Time Frame
Week 0 and 12
Title
Body composition change
Description
Fat mass and fat-free mass as measured by dual X-ray absorptiometry
Time Frame
Week 0 and 12
Title
Glucose tolerance change
Description
2-hour oral glucose tolerance
Time Frame
Week 0 and 12
Title
Cardiometabolic health change
Description
As measured by cholesterol, triglycerides, high- and low-density lipoproteins
Time Frame
Week 0 and 12
Title
Heart rate variability change
Description
As measured by a 12-minute sit to stand protocol with heart rate monitor
Time Frame
Week 0 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann E Caldwell, PhD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility and Impact of Yoga in Obesity

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