Program for Screening and Prevention of Eating Disorders... | NCT03357354

Studies
Program for Screening and Prevention of Eating Disorders in Obese Young People in Vulnerable Neighborhoods of Marseille: an Action Research

NCT03357354

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Terminated

Last Update Posted

Jun 25, 2024Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

collective workshop

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

difficulty of inclusion

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Mar 4, 2020Actual

Completion Date

Mar 4, 2020Actual

First Submitted Date

Nov 23, 2017

First Submission Date that Met QC Criteria

Nov 28, 2017

First Posted Date

Nov 29, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2024

Last Update Posted Date

Jun 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obese Children in precarious situations	Experimental		Behavioral: collective workshop

Interventions

Name	Type	Description	Arm Group Labels	Other Names
collective workshop	Behavioral	diet, sports games, food budget, feeling of satiety and hunger, self-image	Obese Children in precarious situations

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	6 MONTHS

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of with the ADO-BEDS	children and teenagers will be asked to answer some items	6 MONTHS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

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

Exclusion Criteria:

Child with major difficulty of behavior
Patient with medical care

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

11 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urielle DESALBRES	Assistance Publique Hopitaux De Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille		Marseille		13354	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

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