Trauma Exposure, Emotion Regulation and Eating Pathology... | NCT03009825

Studies
Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

NCT03009825

Sponsor

University of Paris 5 - Rene Descartes

Status

Completed

Last Update Posted

Dec 26, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

May 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Jan 2, 2017

First Submission Date that Met QC Criteria

Jan 3, 2017

First Posted Date

Jan 4, 2017Estimated

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

Dec 22, 2018

Last Update Posted Date

Dec 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ruffault Alexis, Doctoral candidate, University of Paris 5 - Rene DescartesPrincipal Investigator

Lead Sponsor

University of Paris 5 - Rene DescartesOTHER

Collaborators

Name	Class
European Georges Pompidou Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported binge eating pathology (BES)	Binge Eating Scale	Baseline

Secondary Outcomes

Measure	Description	Time Frame
Self-reported anxiety and depression (HADS)	Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression	Baseline
Self-reported mindfulness skills (FFMQ)	Five Facets Mindfulness Questionnaire (version: 15 items): observe, describe, act with awareness, non-judgment, non-react

Other Outcomes

Measure	Description	Time Frame
Sociodemographics and medical data	Form filled out by the participants	Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults
Obese (BMI >= 30)
Recruited from the nutrition service of Hôpital Européen Georges-Pompidou
Informed consent provided

Exclusion Criteria:

PTSD symptoms (score > 33 ; PTSD Checklist-5)
Bariatric surgery patients
Difficulties to understand French language
Patients under social protection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with obesity

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cécile Flahault, PhD	University Paris 5 - Rene Descartes	Study Director
Sébastien Czernichow, Pr	University Paris 5 - Rene Descartes	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Europeen Georges Pompidou		Paris		75015	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D000080103	Emotional Regulation

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided