Back to resultsYoga for Abdominal Obesity
Primary Purpose
Obesity, Abdominal
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Yoga
Sponsored by
About this trial
This is an interventional treatment trial for Obesity, Abdominal
Eligibility Criteria
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
Sites / Locations
- Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Yoga
Waitlist
Arm Description
This group will participate in 12 weeks of yoga
No intervention
Outcomes
Primary Outcome Measures
Waist circumference
Secondary Outcome Measures
BMI
Body Mass Index
Body weight
Quality of life
36-Item Short Form Health Survey (SF-36)
Self esteem
Self-Esteem Scale (SES):
Body awareness
Body Awareness Questionnaire (BAQ)
Body responsiveness
Body Responsiveness Scale (BRS)
Perceived stress
Cohen's Perceived Stress Scale (PSS):
Health-specific self-efficacy
Health-Specific Self-Efficacy Scale
Fruits and vegetables consumption
Five A Day Food Frequency Questionnaire (FADFFQ)
Physical activity
The Questionnaire of Baecke et al. for the Measurement of a Person´s Habitual Physical Activity
Adherence
Class attendance and home practice (log)
Adverse events
Safety will be assessed as adverse events and serious adverse events
Qualitative interview
Qualitative interview on experiences and perceived changes
Waist-hip ratio
Bioelectrical impedance analysis
Systolic blood pressure
Diastolic blood pressure
Full Information
NCT ID
NCT02420145
First Posted
April 9, 2015
Last Updated
September 22, 2015
Sponsor
Universität Duisburg-Essen
1. Study Identification
Unique Protocol Identification Number
NCT02420145
Brief Title
Yoga for Abdominal Obesity
Official Title
Randomized-controlled Trial of Yoga for Women With Abdominal Obesity
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universität Duisburg-Essen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Yoga
Arm Type
Experimental
Arm Description
This group will participate in 12 weeks of yoga
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Behavioral
Intervention Name(s)
Yoga
Intervention Description
12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop
Primary Outcome Measure Information:
Title
Waist circumference
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
BMI
Description
Body Mass Index
Time Frame
Week 12
Title
Body weight
Time Frame
Week 12
Title
Quality of life
Description
36-Item Short Form Health Survey (SF-36)
Time Frame
Week 12
Title
Self esteem
Description
Self-Esteem Scale (SES):
Time Frame
Week 12
Title
Body awareness
Description
Body Awareness Questionnaire (BAQ)
Time Frame
Week 12
Title
Body responsiveness
Description
Body Responsiveness Scale (BRS)
Time Frame
Week 12
Title
Perceived stress
Description
Cohen's Perceived Stress Scale (PSS):
Time Frame
Week 12
Title
Health-specific self-efficacy
Description
Health-Specific Self-Efficacy Scale
Time Frame
Week 12
Title
Fruits and vegetables consumption
Description
Five A Day Food Frequency Questionnaire (FADFFQ)
Time Frame
Week 12
Title
Physical activity
Description
The Questionnaire of Baecke et al. for the Measurement of a Person´s Habitual Physical Activity
Time Frame
Week 12
Title
Adherence
Description
Class attendance and home practice (log)
Time Frame
Week 12
Title
Adverse events
Description
Safety will be assessed as adverse events and serious adverse events
Time Frame
Week 12
Title
Qualitative interview
Description
Qualitative interview on experiences and perceived changes
Time Frame
Week 12
Title
Waist-hip ratio
Time Frame
Week 12
Title
Bioelectrical impedance analysis
Time Frame
Week 12
Title
Systolic blood pressure
Time Frame
Week 12
Title
Diastolic blood pressure
Time Frame
Week 12
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
City
Essen
ZIP/Postal Code
45276
Country
Germany
12. IPD Sharing Statement
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Yoga for Abdominal Obesity
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