Eating DisordersCOVITANCT04492189
Containment Measures and Eating Disorders
An observational study of Eating Disorders and COVID 19, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eating Disorders, COVID 19
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 30 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients are adult women with a diagnostic of ED
Who may be able to join
- Adult women
- Surferring from ED
- Assessed in the ED daily hospital (UH of Montpellier) from January to March 2020
Who cannot join
- minors
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Containment Measures in People With Eating Disorders: a Descriptive Study
Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms.
In addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ED). Finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. Thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ED.
Read the detailed description
Investigators will recruit 40 patients with eating disorders. All patients were initially assessed in the daily hospital of the Endocrinology, Diabetes, Nutrition Department (Montpellier University Hospital) from January to march 2020.
All participants will performed a phone interview to assess eating disorder symptoms, caracteristicus of containment, 1 month after the beginning of the containment, and 1 month after the end of the containment.
- Conditions
- Eating Disorders, COVID 19
- Medical subject headings
- Feeding and Eating Disorders, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in eating disorders
the investigators aim to investigate the link between containment measures
Measured: 1 month
Variation in eating disorders
the investigators aim to investigate the link between ED symptomatology with EDE-Q (eating disorder evaluation, caractéristiques du TCA)
Measured: 1 month
Secondary outcomes (6)
Vision of the bodily aspect
The investigators aim to investigate the link between containment measures
Measured: 1 month
Vision of the bodily aspect
The investigators aim to investigate the link between body dissatisfaction
Measured: 1 month
Variation in physical activity
the investigators aim to investigate the link between containment measures
Measured: 1 month
Variation in physical activity
the investigators aim to investigate the link between physical activity
Measured: 1 month
Identify the clinical factors modulating the psychological state during confinement
the investigators aim to investigate the link between containment measures
Measured: 1 month
Identify the clinical factors modulating the psychological state during confinement
the investigators aim to investigate the link between emotional eating
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start1 Apr 2020
- Primary completion30 May 2020
- Study completion30 Jun 2020
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM U1061 (Statistics)
- Responsible party
- Sponsor
- Investigators
- Ariane SULTAN, PR, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492189
- Sponsor's protocol ID
- RECHMPL20_0220
- Acronym
- COVITA
- Status last verified
- Jun 2020
- First submitted
- 19 Apr 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Containment Measures in People With Eating Disorders: a Descriptive Study
- ClinicalTrials.gov ID
- NCT04492189
- Acronym / sponsor ID
- COVITA / RECHMPL20_0220
- Conditions
- Eating Disorders, COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INSERM U1061 (Statistics)
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Jul 2020 (actual)
- 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.
Since March 17, 2020, the French government has implemented national containment measures due to the COVID-19 epidemic. Quarantine is an unpleasant experience : Separation from relatives, loss of liberty, concern about the infectious status, boredom, can negatively affect mental health, with the emergence of anxiety and depressive symptoms.
In addition, confinement can disrupt usual physical activity, a major destabilization criterion for patients suffering from eating disorders (ED). Finally, conditions of confinement can harm social support, yet identified as a protective and resilience factor in stress contexts. Thus, the current context of confinement and social distances could be source of an increase in eating behavior disorders symptoms in people suffering from ED.
Detailed description
Investigators will recruit 40 patients with eating disorders. All patients were initially assessed in the daily hospital of the Endocrinology, Diabetes, Nutrition Department (Montpellier University Hospital) from January to march 2020.
All participants will performed a phone interview to assess eating disorder symptoms, caracteristicus of containment, 1 month after the beginning of the containment, and 1 month after the end of the containment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients are adult women with a diagnostic of ED
Key inclusion criteria (3 listed)
- Adult women
- Surferring from ED
- Assessed in the ED daily hospital (UH of Montpellier) from January to March 2020
Key exclusion criteria (2 listed)
- minors
- refusal to participate
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
Variation in eating disorders
Time frame: 1 month
the investigators aim to investigate the link between containment measures
Variation in eating disorders
Time frame: 1 month
the investigators aim to investigate the link between ED symptomatology with EDE-Q (eating disorder evaluation, caractéristiques du TCA)
6 secondary outcomes
Vision of the bodily aspect
Time frame: 1 month
Vision of the bodily aspect
Time frame: 1 month
Variation in physical activity
Time frame: 1 month
Variation in physical activity
Time frame: 1 month
Identify the clinical factors modulating the psychological state during confinement
Time frame: 1 month
Identify the clinical factors modulating the psychological state during confinement
Time frame: 1 month
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 30 Jul 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Ariane SULTAN, PR study director
University Hospital, Montpellier
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 COVID 19, run by University Hospital, Montpellier 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 3 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 30 Jul 2020. 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?
Variation in eating disorders (time frame: 1 month). The study lists 2 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 30 Jul 2020.