- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420145
Yoga for Abdominal Obesity
September 22, 2015 updated by: Holger Cramer, Universität Duisburg-Essen
Randomized-controlled Trial of Yoga for Women With Abdominal Obesity
The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to no specific intervention on weight-related outcomes, well-being, and health behaviour in 60 females with abdominal obesity.
Study Overview
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Essen, Germany, 45276
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Waist circumference at least 88cm
- Body mass index at least 25
- Sedentary
- Physical and mental ability to participate in the yoga intervention
- Willingness to participate in at least 18 of 24 yoga sessions and the whole-day workshop
Exclusion Criteria:
- Dementia
- Psychosis
- Severe hypertension (diastolic blood pressure more than 120mmHg)
- Type 1 diabetes or insulin-dependent 2 diabetes
- Coronary artery disease
- Myocardial infarction
- Lung embolism
- Stroke
- Regular physical activity or yoga practice
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga
This group will participate in 12 weeks of yoga
|
12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop
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No Intervention: Waitlist
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Waist circumference
Time Frame: Week 12
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI
Time Frame: Week 12
|
Body Mass Index
|
Week 12
|
Body weight
Time Frame: Week 12
|
Week 12
|
|
Quality of life
Time Frame: Week 12
|
36-Item Short Form Health Survey (SF-36)
|
Week 12
|
Self esteem
Time Frame: Week 12
|
Self-Esteem Scale (SES):
|
Week 12
|
Body awareness
Time Frame: Week 12
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Body Awareness Questionnaire (BAQ)
|
Week 12
|
Body responsiveness
Time Frame: Week 12
|
Body Responsiveness Scale (BRS)
|
Week 12
|
Perceived stress
Time Frame: Week 12
|
Cohen's Perceived Stress Scale (PSS):
|
Week 12
|
Health-specific self-efficacy
Time Frame: Week 12
|
Health-Specific Self-Efficacy Scale
|
Week 12
|
Fruits and vegetables consumption
Time Frame: Week 12
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Five A Day Food Frequency Questionnaire (FADFFQ)
|
Week 12
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Physical activity
Time Frame: Week 12
|
The Questionnaire of Baecke et al. for the Measurement of a Person´s Habitual Physical Activity
|
Week 12
|
Adherence
Time Frame: Week 12
|
Class attendance and home practice (log)
|
Week 12
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Adverse events
Time Frame: Week 12
|
Safety will be assessed as adverse events and serious adverse events
|
Week 12
|
Qualitative interview
Time Frame: Week 12
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Qualitative interview on experiences and perceived changes
|
Week 12
|
Waist-hip ratio
Time Frame: Week 12
|
Week 12
|
|
Bioelectrical impedance analysis
Time Frame: Week 12
|
Week 12
|
|
Systolic blood pressure
Time Frame: Week 12
|
Week 12
|
|
Diastolic blood pressure
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
April 9, 2015
First Submitted That Met QC Criteria
April 14, 2015
First Posted (Estimate)
April 17, 2015
Study Record Updates
Last Update Posted (Estimate)
September 23, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-6194-BO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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