Eating DisordersPhase 1NCT00870753
Yoga in Treatment of Eating Disorders
A Phase 1 study testing Yoga in people with Eating Disorders, run by Norwegian School of Sport Sciences at 1 site in Norway.
Trial summary
Purpose: to examine effects of hatha yoga in treatment of eating disorders. Methods: Participants: patients with DSM-IV Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not Otherwise Specified will be invited to participate in this study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders
- 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
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2009to Dec 2011
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 or above
- DSM-IV Anorexia nervosa, Bulimia nervosa or Eating disorders not otherwise specified
Who cannot join
- serious medical complications
- psychosis
- suicidal behavior
Trial locations and contacts
1 site in 1 country.
Kari E Karlsen, psych student contact
Solfrid Bratland-Sanda, master sports science contact
Norway1 site, 1 recruiting
- Recruiting
Norwegian School of Sport Sciences
Oslo, Oslo, 0806
Kari E Karlsen, psych student
Jorunn Sundgot-Borgen, PhD
About this study
Purpose: to examine effects of hatha yoga in treatment of eating disorders.
Methods:
Participants: patients with DSM-IV Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not Otherwise Specified will be invited to participate in this study. Exclusion criteria will be age under 18, serious medical complications, psychosis or increased risk of suicide.
Design: randomized controlled single-blinded trial. Intervention: 2 x 90 min weekly group sessions for 12 weeks with hatha yoga. Main outcome measure: reduction in Eating Disorders Examination score. Secondary outcome measures: reduction in body dissatisfaction, depression and anxiety
Read the detailed description
For the last years, yoga has become a popular "body-mind" form of exercise in western countries (Daubenmier, 2005). Yoga has shown good effects on increasing muscle strength, flexibility and stability, in addition studies have found reduced stress level, improved mood and breathing (Astin et al., 2003; Gimbel, 1998b; Granath et al., 2006; Lavey et al., 2005; Manjunatha et al., 2005b; Netz \& Lidor, 2003a; Telles \& Naveen, 1997b; Yadav et al., 2005b). Previous research have shown a tendency for persons practicing yoga improving body awareness and body sensitivity, and reduction of body dissatisfaction (Daubenmier, 2005). In addition, two studies have examined yoga in treatment of binge eating disorder (Daubenmier, 2005; Gimbel, 1998a). Results showed reduction in number of binge eating episodes in the intervention group compared to the control group. No available studies have examined effect of yoga in treatment of the eating disorders types Anorexia Nervosa or Bulimia Nervosa.
- Conditions
- Eating Disorders
- Being tested
- Yoga
- Keywords
- Eating disorders, yoga, body awareness, depression, anxiety
- Medical subject headings
- Feeding and Eating Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
90 min hatha yoga 2 times per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | 90 min hatha yoga 2 times per week for 12 weeks. Receives: Behavioral: Yoga |
| Controls | No intervention | Control group are offered the yoga intervention after finishing the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
reduction in eating disorders symptoms assessed by Eating Disorders Examination clinical interview
Measured: after 12 weeks
Secondary outcomes (1)
increased body awareness
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian School of Sport Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870753
- Sponsor's protocol ID
- 2.2006.1243
- Status last verified
- Mar 2009
- First submitted
- 26 Mar 2009
- Last updated
- 27 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga in Treatment of Eating Disorders
- ClinicalTrials.gov ID
- NCT00870753
- Acronym / sponsor ID
- 2.2006.1243
- Conditions
- Eating Disorders
- Keywords
- Eating disorders, yoga, body awareness, depression, anxiety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Norwegian School of Sport SciencesUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 27 Mar 2009 (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.
Purpose: to examine effects of hatha yoga in treatment of eating disorders.
Methods:
Participants: patients with DSM-IV Anorexia Nervosa, Bulimia Nervosa or Eating Disorders Not Otherwise Specified will be invited to participate in this study. Exclusion criteria will be age under 18, serious medical complications, psychosis or increased risk of suicide.
Design: randomized controlled single-blinded trial. Intervention: 2 x 90 min weekly group sessions for 12 weeks with hatha yoga. Main outcome measure: reduction in Eating Disorders Examination score. Secondary outcome measures: reduction in body dissatisfaction, depression and anxiety
Detailed description
For the last years, yoga has become a popular "body-mind" form of exercise in western countries (Daubenmier, 2005). Yoga has shown good effects on increasing muscle strength, flexibility and stability, in addition studies have found reduced stress level, improved mood and breathing (Astin et al., 2003; Gimbel, 1998b; Granath et al., 2006; Lavey et al., 2005; Manjunatha et al., 2005b; Netz \& Lidor, 2003a; Telles \& Naveen, 1997b; Yadav et al., 2005b). Previous research have shown a tendency for persons practicing yoga improving body awareness and body sensitivity, and reduction of body dissatisfaction (Daubenmier, 2005). In addition, two studies have examined yoga in treatment of binge eating disorder (Daubenmier, 2005; Gimbel, 1998a). Results showed reduction in number of binge eating episodes in the intervention group compared to the control group. No available studies have examined effect of yoga in treatment of the eating disorders types Anorexia Nervosa or Bulimia Nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Behavioral: Yoga90 min hatha yoga 2 times per week for 12 weeks. |
| Controls | No intervention | –Control group are offered the yoga intervention after finishing the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 or above
- DSM-IV Anorexia nervosa, Bulimia nervosa or Eating disorders not otherwise specified
Key exclusion criteria (3 listed)
- serious medical complications
- psychosis
- suicidal behavior
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 |
|---|---|---|
| Yoga90 min hatha yoga 2 times per week for 12 weeks. | Behavioural | Yoga |
Primary outcome
reduction in eating disorders symptoms assessed by Eating Disorders Examination clinical interview
Time frame: after 12 weeks
1 secondary outcome
increased body awareness
Time frame: after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2009.
Related trials for Eating Disorders
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
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.
Kari E Karlsen, psych student contact
Solfrid Bratland-Sanda, master sports science contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Yoga in people with Eating Disorders, run by Norwegian School of Sport Sciences at 1 site in Norway.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Mar 2009. 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 Norway. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kari E Karlsen, psych student (k.e.karlsen@psykologi.uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reduction in eating disorders symptoms assessed by Eating Disorders Examination clinical interview (time frame: after 12 weeks). 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 27 Mar 2009.