Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients (TrOma)

December 22, 2018 updated by: Ruffault Alexis, University of Paris 5 - Rene Descartes

TrOma: A Cross-sectional Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with obesity

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported anxiety and depression (HADS)
Time Frame: Baseline
Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression
Baseline
Self-reported mindfulness skills (FFMQ)
Time Frame: Baseline
Five Facets Mindfulness Questionnaire (version: 15 items): observe, describe, act with awareness, non-judgment, non-react
Baseline
Self-reported emotion regulation (CERQ)
Time Frame: Baseline
Cognitive Emotional Regulation Questionnaire (2 subscales): adaptive regulation and non-adaptive regulation
Baseline
Self-reported eating patterns (TFEQ-R18)
Time Frame: Baseline
Three Factor Eating Questionnaire (3 subscales): emotional eating, uncontrolled eating, restraint eating
Baseline
Self-reported impact of traumatic event (IES-R)
Time Frame: Baseline
Impact of Event Scale revised version (3 subscales): avoidance, intrusion, hyperarousal
Baseline
Self-reported childhood trauma (CTQ)
Time Frame: Baseline
Childhood Trauma Questionnaire (5 subscales): emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse
Baseline
Self-reported lifetime traumatic events (LEC-5)
Time Frame: Baseline
Life Event Checklist (DSM-5)
Baseline
Body Mass Index (kg/m2)
Time Frame: Baseline
BMI as measured by a physician
Baseline

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 5 - Rene Descartes

Collaborators

European Georges Pompidou Hospital

Investigators

  • Study Director: Cécile Flahault, PhD, University Paris 5 - Rene Descartes
  • Principal Investigator: Sébastien Czernichow, Pr, University Paris 5 - Rene Descartes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

December 26, 2018

Last Update Submitted That Met QC Criteria

December 22, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA4057-troma

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe