Eating DisordersTCA SHNNCT01544400
Description and Evaluation of Eating Disorders in Elite Athletes (TCA SHN)
An observational study of Eating Disorders and Anorexia Nervosa, run by Nantes University Hospital at 1 site in France.
Trial summary
Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Eating Disorders, Anorexia Nervosa, Boulimia Nervosa
- How many people
- 386 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2010to Jan 2013
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Athletes registered on the high level sportsmen list or in access to high level sport
Who may be able to join
- to have at least 12 years
- to be registered on the high level sportsmen list or to be in access to high level sport
- to have obtained the non opposition of the athlete if he is major (if not the legal person in charge of the athlete have to give is non opposition).
- to be affiliated to social security
Who cannot join
- presenting obvious cognitive disturbance
- not able to understand or/ and to read French language
- pregnant women
- subject under tutelage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Description and Evaluation of Eating Disorders in Elite Athletes
Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. These eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described.
Our aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.
- Keywords
- reverse anorexia,, anorexia athletics
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Binge-Eating Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of eating disorder
A subject presents an eating disorder if at least one of the tree clinical investigators (somatician, dietician, psychologist) mark it.
Eating disorders will be described by:
Dietetic consultation, Somatic examination, Psychological evaluation
Measured: 1 day
Secondary outcomes (5)
Presence of eating disorder according to the psychologist, dietician and the somatician
Presence of eating disorder according to the psychologist, dietician and the somatician
Measured: 1 day
Sociodemographic variables
age, sex, sporting discipline exercised
Measured: 1 day
Doping conduits variables
age of onset of consumption (PAP support products performance) legal and illegal, current frequency of consumption of PAP licit and illicit consumption as problematic or not the patient.
Measured: 1 day
Investment in practice sporting variables
Desired level of sports, number of hours per week over the last 4 weeks, up / concern of the sport.
Measured: 1 day
Addictives and psychiatric comorbidity
anxiety disorders, depression and sleep disorders Scale : GEEMS, EDI, EDS-R
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study startJun 2010
- Primary completionJan 2013
- Study completionJan 2013
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.
- More trials run by Nantes University HospitalThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephane Pretagut, Principal investigator, Nantes University HospitalSerge Lise, Principal investigator, University Hospital, BordeauxMichel GUINOT, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544400
- Sponsor's protocol ID
- BRD/09/03-V
- Acronym
- TCA SHN
- Status last verified
- Aug 2016
- First submitted
- 17 Feb 2012
- Last updated
- 8 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description and Evaluation of Eating Disorders in Elite Athletes
- ClinicalTrials.gov ID
- NCT01544400
- Acronym / sponsor ID
- TCA SHN / BRD/09/03-V
- Keywords
- reverse anorexia,, anorexia athletics
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Mar 2012 (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.
Athletes in particular elite athletes have obsessional food and body concerns, in bond with a worship of the performance more and more invading, which lead to clinical and subclinical eating disorders. These eating disorders differ according to the disciplines and are difficult to diagnose in athletes because there are insufficiently described.
Our aim at estimating the frequency of eating disorders in athletes and describing eating disorders by means of somatic, dietetic and psychological evaluations.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Athletes registered on the high level sportsmen list or in access to high level sport
Key inclusion criteria (4 listed)
- to have at least 12 years
- to be registered on the high level sportsmen list or to be in access to high level sport
- to have obtained the non opposition of the athlete if he is major (if not the legal person in charge of the athlete have to give is non opposition).
- to be affiliated to social security
Key exclusion criteria (4 listed)
- presenting obvious cognitive disturbance
- not able to understand or/ and to read French language
- pregnant women
- subject under tutelage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of eating disorder
Time frame: 1 day
A subject presents an eating disorder if at least one of the tree clinical investigators (somatician, dietician, psychologist) mark it. Eating disorders will be described by: Dietetic consultation, Somatic examination, Psychological evaluation
5 secondary outcomes
Presence of eating disorder according to the psychologist, dietician and the somatician
Time frame: 1 day
Sociodemographic variables
Time frame: 1 day
Doping conduits variables
Time frame: 1 day
Investment in practice sporting variables
Time frame: 1 day
Addictives and psychiatric comorbidity
Time frame: 1 day
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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.
Stephane Pretagut principal investigator
Nantes University Hospital
Serge Lise principal investigator
University Hospital, Bordeaux
Michel GUINOT principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders and Anorexia Nervosa, run by Nantes University Hospital at 1 site in France.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Aug 2016. 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 France. 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 was stopped early. Results are not available in the source record.
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?
Presence of eating disorder (time frame: 1 day). 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 8 Aug 2016.