Obesity, Abdominal Clinical Trial
Official title:
Randomized-controlled Trial of Yoga for Women With Abdominal Obesity
| Verified date | September 2015 |
| Source | Universität Duisburg-Essen |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 64 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen | Essen |
| Lead Sponsor | Collaborator |
|---|---|
| Universität Duisburg-Essen |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Waist circumference | Week 12 | No | |
| Secondary | BMI | Body Mass Index | Week 12 | No |
| Secondary | Body weight | Week 12 | No | |
| Secondary | Quality of life | 36-Item Short Form Health Survey (SF-36) | Week 12 | No |
| Secondary | Self esteem | Self-Esteem Scale (SES): | Week 12 | No |
| Secondary | Body awareness | Body Awareness Questionnaire (BAQ) | Week 12 | No |
| Secondary | Body responsiveness | Body Responsiveness Scale (BRS) | Week 12 | No |
| Secondary | Perceived stress | Cohen's Perceived Stress Scale (PSS): | Week 12 | No |
| Secondary | Health-specific self-efficacy | Health-Specific Self-Efficacy Scale | Week 12 | No |
| Secondary | Fruits and vegetables consumption | Five A Day Food Frequency Questionnaire (FADFFQ) | Week 12 | No |
| Secondary | Physical activity | The Questionnaire of Baecke et al. for the Measurement of a Person“s Habitual Physical Activity | Week 12 | No |
| Secondary | Adherence | Class attendance and home practice (log) | Week 12 | No |
| Secondary | Adverse events | Safety will be assessed as adverse events and serious adverse events | Week 12 | Yes |
| Secondary | Qualitative interview | Qualitative interview on experiences and perceived changes | Week 12 | No |
| Secondary | Waist-hip ratio | Week 12 | No | |
| Secondary | Bioelectrical impedance analysis | Week 12 | No | |
| Secondary | Systolic blood pressure | Week 12 | No | |
| Secondary | Diastolic blood pressure | Week 12 | No |
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