Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

Obesity Clinical Trial

— TrOma  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03009825
• Other study ID #: EA4057-troma
• Status: Completed
• Start date: January 2017
• Est. completion date: May 2017

Study information

• Verified date: December 2018
• Source: University of Paris 5 - Rene Descartes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
France	Hopital Europeen Georges Pompidou	Paris

Sponsors (2)

Lead Sponsor	Collaborator
University of Paris 5 - Rene Descartes	European Georges Pompidou Hospital

Country where clinical trial is conducted

France, 

Outcome

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