Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

Completed

• Conditions: Obesity

• Registration Number: NCT03009825
• Lead Sponsor: University of Paris 5 - Rene Descartes

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 available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-04
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-22
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported binge eating pathology (BES)	Baseline	Binge Eating Scale

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hopital Europeen Georges Pompidou; 🇫🇷 Paris, France