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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02420145
Other study ID # 15-6194-BO
Secondary ID
Status Completed
Phase N/A
First received April 9, 2015
Last updated September 22, 2015
Start date April 2015
Est. completion date August 2015

Study information

Verified date September 2015
Source Universität Duisburg-Essen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Yoga
12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop

Locations

Country Name City State
Germany Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen Essen

Sponsors (1)

Lead Sponsor Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

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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