ObesityNCT03357354
Program for Screening and Prevention of Eating Disorders in Obese Young People in Vulnerable Neighborhoods of Marseille: an Action Research
A study testing collective workshop in people with Obesity, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Action research has been developed in this direction in order to use a tool to identify food disorder behavior among obese youths in their neighborhoods and social centers in vulnerable neighborhoods of Marseille, with the aim of a multi-professional therapeutic management (psychosocial support, theater) and a… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Obesity
- What is being tested?
- collective workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to 4 Mar 2020
- 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 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys or girls aged 11 to 17
- Reside in the territory of intervention of the mobile team, i.e the 3rd, 14th, 15th and 16th arrondissement of Marseille, districts said to be vulnerable by the city's policy.
- Body mass index greater than or equal to IOTF-30 (HAS, 2011)
- Social precariousness score EPICES greater than or equal to 30riteria:
- Diagnosed Eating Disorder without medical and/or multi-professional care
Who cannot join
- Child with major difficulty of behavior
- Patient with medical care
Trial locations and contacts
1 site in 1 country.
About this study
Action research has been developed in this direction in order to use a tool to identify food disorder behavior among obese youths in their neighborhoods and social centers in vulnerable neighborhoods of Marseille, with the aim of a multi-professional therapeutic management (psychosocial support, theater) and a specialized orientation.
This program consists of the participation of each patient recruited in collective workshops. A total of 60 patients considered. Our hypothesis lies in the fact that for young people to participate in an adapted device, taking into account the global needs of young people and their entourage, would limit the deleterious effects of obesity and promote the young person's autonomy and allow him to be a actor in the request for care.
The project's objective is to provide support in the form of workshops with patients identified by the Marseille Hospitals Public Assistance Health Center as obese children and adolescents, in a precarious situation; to identify the presence of binge eating disorders and evaluate the impact of participation in these workshops on subsequent management by highly specialized professionals in food disorder behavior.
Read the detailed description
The mobile team (EM) of the Marseille Hospitals Public Assistance Health Center has the mission to inform, screen, support and guide the access to care of people in targeted neighborhoods, said to be vulnerable, by the city's policy of Marseille. The health space, a place of welcome and care, is located at a distance from any hospital structure within the most vulnerable neighborhoods of the city.
- Conditions
- Obesity
- Being tested
- collective workshop
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collective workshopBehavioural
diet, sports games, food budget, feeling of satiety and hunger, self-image
| Study group | Role | What they receive |
|---|---|---|
| Obese Children in precarious situations | Experimental | Not described Receives: Behavioral: collective workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects included in the three months following the end of the workshops in a device specialized in the management of behavioral disorders.
Tracking interview after the end of workshops
Measured: 6 MONTHS
Secondary outcomes (1)
Evaluation of with the ADO-BEDS
children and teenagers will be asked to answer some items
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start1 Feb 2018
- Primary completion4 Mar 2020
- Study completion4 Mar 2020
Why it stopped: difficulty of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03357354
- Sponsor's protocol ID
- 2017-31
- Status last verified
- Nov 2017
- First submitted
- 23 Nov 2017
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for Screening and Prevention of Eating Disorders in Obese Young People in Vulnerable Neighborhoods of Marseille: an Action Research
- ClinicalTrials.gov ID
- NCT03357354
- Acronym / sponsor ID
- 2017-31
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty of inclusion
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 4 Mar 2020 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 29 Nov 2017 (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.
Action research has been developed in this direction in order to use a tool to identify food disorder behavior among obese youths in their neighborhoods and social centers in vulnerable neighborhoods of Marseille, with the aim of a multi-professional therapeutic management (psychosocial support, theater) and a specialized orientation.
This program consists of the participation of each patient recruited in collective workshops. A total of 60 patients considered. Our hypothesis lies in the fact that for young people to participate in an adapted device, taking into account the global needs of young people and their entourage, would limit the deleterious effects of obesity and promote the young person's autonomy and allow him to be a actor in the request for care.
The project's objective is to provide support in the form of workshops with patients identified by the Marseille Hospitals Public Assistance Health Center as obese children and adolescents, in a precarious situation; to identify the presence of binge eating disorders and evaluate the impact of participation in these workshops on subsequent management by highly specialized professionals in food disorder behavior.
Detailed description
The mobile team (EM) of the Marseille Hospitals Public Assistance Health Center has the mission to inform, screen, support and guide the access to care of people in targeted neighborhoods, said to be vulnerable, by the city's policy of Marseille. The health space, a place of welcome and care, is located at a distance from any hospital structure within the most vulnerable neighborhoods of the city.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese Children in precarious situations | Experimental | Behavioral: collective workshop |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Boys or girls aged 11 to 17
- Reside in the territory of intervention of the mobile team, i.e the 3rd, 14th, 15th and 16th arrondissement of Marseille, districts said to be vulnerable by the city's policy.
- Body mass index greater than or equal to IOTF-30 (HAS, 2011)
- Social precariousness score EPICES greater than or equal to 30riteria:
- Diagnosed Eating Disorder without medical and/or multi-professional care
Key exclusion criteria (2 listed)
- Child with major difficulty of behavior
- Patient with medical care
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 |
|---|---|---|
| collective workshopdiet, sports games, food budget, feeling of satiety and hunger, self-image | Behavioural | Obese Children in precarious situations |
Primary outcome
Number of subjects included in the three months following the end of the workshops in a device specialized in the management of behavioral disorders.
Time frame: 6 MONTHS
Tracking interview after the end of workshops
1 secondary outcome
Evaluation of with the ADO-BEDS
Time frame: 6 MONTHS
Results and safety
The study was stopped early (reason given: difficulty of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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.
Urielle DESALBRES study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collective workshop in people with Obesity, run by Assistance Publique Hopitaux De Marseille 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 5 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: stopped early, as of the sponsor's last update on 25 Jun 2024. 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 (reason given: difficulty of inclusion). 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?
Number of subjects included in the three months following the end of the workshops in a device specialized in the management of behavioral disorders. (time frame: 6 MONTHS). 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 25 Jun 2024.