Anorexia NervosaTEPNCT02191995
Yoga in the Treatment of Eating Disorders: a Randomized Trial
A study testing yoga in people with Anorexia Nervosa and Bulimia Nervosa, run by University of Minnesota at 1 site in United States.
Trial summary
Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Bulimia Nervosa
- 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
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- admitted to the Anna Westin House treatment facility of the Emily Program in MN during timeframe study is being run
Who cannot join
- declines participation in study
Trial locations and contacts
1 site in 1 country.
About this study
Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Being tested
- yoga
- Medical subject headings
- Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
yogaBehavioural
| Study group | Role | What they receive |
|---|---|---|
| body awareness yoga | Experimental | body awareness yoga session prior to breakfast meal Receives: Behavioral: yoga |
| Control Arm | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' level of mood and anxiety
The Positive And Negative Affect Scale will be administered daily prior to and after supper in order to assess anxiety and mood.
Measured: Week 4
Secondary outcomes (2)
Level of eating disorder symptoms
The Eating Disorder Examination-Questionnaire will be administered to evaluate clients' eating disorder symptoms and prevalence.
Measured: Week 4
Participants' ability to tolerance distress
The Distress Tolerance Scale will be administered to follow clients' ability to cope with highly charged emotions.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dianne Neumark-Sztainer, PhD MPH RD, Principal investigator, University of MinnesotaCarol Peterson, PhD LP, Principal investigator, University of MinnesotaScott Crow, MD, Principal investigator, University of MinnesotaLisa Diers, RD LD RYT, Principal investigator, The Emily Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02191995
- Sponsor's protocol ID
- 1405S51026
- Acronym
- TEP
- Status last verified
- Oct 2019
- First submitted
- 7 May 2014
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga in the Treatment of Eating Disorders: a Randomized Trial
- ClinicalTrials.gov ID
- NCT02191995
- Acronym / sponsor ID
- TEP / 1405S51026
- Conditions
- Anorexia Nervosa, Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 16 Jul 2014 (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.
Yoga facilitates the treatment of eating disorders by decreasing symptom severity over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| body awareness yoga | Experimental | Behavioral: yogabody awareness yoga session prior to breakfast meal |
| Control Arm | No intervention | –No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- admitted to the Anna Westin House treatment facility of the Emily Program in MN during timeframe study is being run
Key exclusion criteria (1 listed)
- declines participation in study
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 |
|---|---|---|
| yoga | Behavioural | body awareness yoga |
Primary outcome
Participants' level of mood and anxiety
Time frame: Week 4
The Positive And Negative Affect Scale will be administered daily prior to and after supper in order to assess anxiety and mood.
2 secondary outcomes
Level of eating disorder symptoms
Time frame: Week 4
Participants' ability to tolerance distress
Time frame: Week 4
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 1 Nov 2019.
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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.
Dianne Neumark-Sztainer, PhD MPH RD principal investigator
University of Minnesota
Carol Peterson, PhD LP principal investigator
University of Minnesota
Scott Crow, MD principal investigator
University of Minnesota
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 Anorexia Nervosa and Bulimia Nervosa, run by University of Minnesota at 1 site in United States.
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 1 inclusion and 1 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 1 Nov 2019. 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 United States. 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?
Participants' level of mood and anxiety (time frame: Week 4). 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 1 Nov 2019.