Anorexia NervosaHAP-AMNCT02165982
Characteristics of Intensity and Dependence to Physical Activity in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by Institut Mutualiste Montsouris at 1 site in France.
Trial summary
Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon clinique à un échantillon de témoins issus de la population générale. Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de patients pris en charge pour anorexie mentale dans des unités de… Read more about this study
- Who is it for?
- Ages 13 to 23 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Sep 2015
- 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 13 to 23 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Pour l'échantillon clinique (patients témoins et contrôles) : prise en charge pour Anorexie Mentale (selon les critères DSM-IV) dans le département de psychiatrie de l'enfant et de l'adolescent de l'Institut Mutualiste Montsouris. Pour l'échantillon individus sains témoins : Sujets issus de la population générale (collégiens lycéens étudiants).
Who may be able to join
- Sujets de sexe masculin et féminin, âgés entre 13 et 23 ans.
- Donnant leur consentement éclairé (et celui des parents pour les mineurs)
- Pour l'échantillon clinique : prise en charge pour Anorexie Mentale (selon les critères DSM-IV) dans le département de psychiatrie de l'enfant et de l'adolescent de l'Institut Mutualiste Montsouris.
- Pour l'échantillon témoin : Sujets issus de la population générale (collégiens lycéens étudiants).
Who cannot join
- Personnes refusant la recherche
- Personnes souffrant d'une condition médicale majeure ou d'une invalidité.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensity and Dependence to Physical Activity and Its Links With Clinical and Emotional Statuses in Comparison With Healthy Controls.
Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon clinique à un échantillon de témoins issus de la population générale.
Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les caractéristiques de l'activité physique et la dépendance à l'exercice physique en comparaison avec des sujets issus de la population générale appariés pour l'âge et le sexe.
Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus dépendants à l'exercice physique que des sujets de la population générale de même âge et de même sexe.
- Conditions
- Anorexia Nervosa
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients controles | Inpatients suffering from anorexia nervosa at Institut Mutualiste Montsouris | |
| Individus sains témoins | Healthy controls selected from the general population |
What is being measured
The primary outcome is the main question the study is designed to answer.
GPAQ-OMS
Questionnaire de l'OMS sur la pratique d'activités physiques
Measured: At initial assessment and 6 weeks later
GLTEQ
Godin Leisure-Time Exercise Questionnaire
Measured: At initial assessment and 6 weeks later
EDS-R
Exercise-Dependence Scale-Revised
Measured: At initial assessment and 6 weeks later
EDQ
Exercise-Dependence Questionnaire ; sélection des questions sur les motivations à pratiquer
Measured: At initial assessment and 6 weeks later
EDE-Q
Eating Disorder Examination Questionnaire
Measured: At initial assessment and 6 weeks later
CIDI
Composite International Diagnostic Interview
Measured: At initial assessment
MOCI
Maudsley Obsessive Compulsive Inventory
Measured: At initial assessment and 6 weeks later
Secondary outcomes (6)
HAD
Hospital Anxiety \& Depression Scale
Measured: At initial assessment and 6 weeks later
EMPF
Echelle Multidimensionnelle de Perfectionnisme de Frost
Measured: At initial assessment and 6 weeks later
TMMS
(Trait Meta Mood Scale)
Measured: At initial assessment and 6 weeks later
RES
(Rosenberg Self-Esteem Scale)
Measured: At initial assessment and 6 weeks later
BSQ
(Body Shape Questionnaire)
Measured: At initial assessment and 6 weeks later
BIA
Impedancemétrie Bioélectrique
Measured: At initial assessment and 6 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startFeb 2014
- Primary completionMay 2015
- Study completionSep 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.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Mutualiste Montsouris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nathalie GODART, Principal investigator, Institut Mutualiste Montsouris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165982
- Sponsor's protocol ID
- 2014-02
- Acronym
- HAP-AM
- Status last verified
- Sep 2016
- First submitted
- 2 May 2014
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity and Dependence to Physical Activity and Its Links With Clinical and Emotional Statuses in Comparison With Healthy Controls.
- ClinicalTrials.gov ID
- NCT02165982
- Acronym / sponsor ID
- HAP-AM / 2014-02
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Institut Mutualiste MontsourisUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jun 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.
Etude d'épidémiologie clinique multicentrique (IMM), naturalistique, comparant un échantillon clinique à un échantillon de témoins issus de la population générale.
Cette recherche se fixe pour objectif principal de déterminer, sur un large échantillon de patients pris en charge pour anorexie mentale dans des unités de soins spécialisées, les caractéristiques de l'activité physique et la dépendance à l'exercice physique en comparaison avec des sujets issus de la population générale appariés pour l'âge et le sexe.
Nous faisons l'hypothèse que les patients anorexiques mentaux sont plus actifs et plus dépendants à l'exercice physique que des sujets de la population générale de même âge et de même sexe.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients controles | – | –Inpatients suffering from anorexia nervosa at Institut Mutualiste Montsouris |
| Individus sains témoins | – | –Healthy controls selected from the general population |
Who may qualify
- Ages
- 13 to 23 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pour l'échantillon clinique (patients témoins et contrôles) : prise en charge pour Anorexie Mentale (selon les critères DSM-IV) dans le département de psychiatrie de l'enfant et de l'adolescent de l'Institut Mutualiste Montsouris. Pour l'échantillon individus sains témoins : Sujets issus de la population générale (collégiens lycéens étudiants).
Key inclusion criteria (4 listed)
- Sujets de sexe masculin et féminin, âgés entre 13 et 23 ans.
- Donnant leur consentement éclairé (et celui des parents pour les mineurs)
- Pour l'échantillon clinique : prise en charge pour Anorexie Mentale (selon les critères DSM-IV) dans le département de psychiatrie de l'enfant et de l'adolescent de l'Institut Mutualiste Montsouris.
- Pour l'échantillon témoin : Sujets issus de la population générale (collégiens lycéens étudiants).
Key exclusion criteria (2 listed)
- Personnes refusant la recherche
- Personnes souffrant d'une condition médicale majeure ou d'une invalidité.
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
GPAQ-OMS
Time frame: At initial assessment and 6 weeks later
Questionnaire de l'OMS sur la pratique d'activités physiques
GLTEQ
Time frame: At initial assessment and 6 weeks later
Godin Leisure-Time Exercise Questionnaire
EDS-R
Time frame: At initial assessment and 6 weeks later
Exercise-Dependence Scale-Revised
EDQ
Time frame: At initial assessment and 6 weeks later
Exercise-Dependence Questionnaire ; sélection des questions sur les motivations à pratiquer
EDE-Q
Time frame: At initial assessment and 6 weeks later
Eating Disorder Examination Questionnaire
CIDI
Time frame: At initial assessment
Composite International Diagnostic Interview
MOCI
Time frame: At initial assessment and 6 weeks later
Maudsley Obsessive Compulsive Inventory
6 secondary outcomes
HAD
Time frame: At initial assessment and 6 weeks later
EMPF
Time frame: At initial assessment and 6 weeks later
TMMS
Time frame: At initial assessment and 6 weeks later
RES
Time frame: At initial assessment and 6 weeks later
BSQ
Time frame: At initial assessment and 6 weeks later
BIA
Time frame: At initial assessment and 6 weeks later
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 13 Sep 2016.
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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.
Nathalie GODART principal investigator
Institut Mutualiste Montsouris
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 Anorexia Nervosa, run by Institut Mutualiste Montsouris 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 2 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 13 Sep 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 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?
GPAQ-OMS (time frame: At initial assessment and 6 weeks later). The study lists 7 primary outcomes in all. 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 13 Sep 2016.