Obesity, AbdominalNCT02420145
Yoga for Abdominal Obesity
A study testing Yoga in people with Obesity, Abdominal, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Dementia
- Psychosis
- Severe hypertension (diastolic blood pressure more than 120mmHg)
- Type 1 diabetes or insulin-dependent 2 diabetes
- Coronary artery disease
- Myocardial infarction
Show all 10Show fewer
- Lung embolism
- Stroke
- Regular physical activity or yoga practice
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte, Faculty of Medicine, University of Duisburg-Essen
Essen, 45276
About this study
Official title: 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.
- Conditions
- Obesity, Abdominal
- Being tested
- Yoga
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | This group will participate in 12 weeks of yoga Receives: Behavioral: Yoga |
| Waitlist | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist circumference
Measured: Week 12
Secondary outcomes (17)
BMI
Body Mass Index
Measured: Week 12
Body weight
Measured: Week 12
Quality of life
36-Item Short Form Health Survey (SF-36)
Measured: Week 12
Self esteem
Self-Esteem Scale (SES):
Measured: Week 12
Body awareness
Body Awareness Questionnaire (BAQ)
Measured: Week 12
Body responsiveness
Body Responsiveness Scale (BRS)
Measured: Week 12
Perceived stress
Cohen's Perceived Stress Scale (PSS):
Measured: Week 12
Health-specific self-efficacy
Health-Specific Self-Efficacy Scale
Measured: Week 12
Fruits and vegetables consumption
Five A Day Food Frequency Questionnaire (FADFFQ)
Measured: Week 12
Physical activity
The Questionnaire of Baecke et al. for the Measurement of a Person´s Habitual Physical Activity
Measured: Week 12
Adherence
Class attendance and home practice (log)
Measured: Week 12
Adverse events
Safety will be assessed as adverse events and serious adverse events
Measured: Week 12
Qualitative interview
Qualitative interview on experiences and perceived changes
Measured: Week 12
Waist-hip ratio
Measured: Week 12
Bioelectrical impedance analysis
Measured: Week 12
Systolic blood pressure
Measured: Week 12
Diastolic blood pressure
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420145
- Sponsor's protocol ID
- 15-6194-BO
- Status last verified
- Sep 2015
- First submitted
- 9 Apr 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial of Yoga for Women With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT02420145
- Acronym / sponsor ID
- 15-6194-BO
- Conditions
- Obesity, Abdominal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: YogaThis group will participate in 12 weeks of yoga |
| Waitlist | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Dementia
- Psychosis
- Severe hypertension (diastolic blood pressure more than 120mmHg)
- Type 1 diabetes or insulin-dependent 2 diabetes
- Coronary artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop | Behavioural | Yoga |
Primary outcome
Waist circumference
Time frame: Week 12
17 secondary outcomes
BMI
Time frame: Week 12
Body weight
Time frame: Week 12
Quality of life
Time frame: Week 12
Self esteem
Time frame: Week 12
Body awareness
Time frame: Week 12
Body responsiveness
Time frame: Week 12
Perceived stress
Time frame: Week 12
Health-specific self-efficacy
Time frame: Week 12
Fruits and vegetables consumption
Time frame: Week 12
Physical activity
Time frame: Week 12
Adherence
Time frame: Week 12
Adverse events
Time frame: Week 12
Qualitative interview
Time frame: Week 12
Waist-hip ratio
Time frame: Week 12
Bioelectrical impedance analysis
Time frame: Week 12
Systolic blood pressure
Time frame: Week 12
Diastolic blood pressure
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Obesity, Abdominal, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist circumference (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.