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Completed

NCT Number: NCT03009825

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.

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Key information

Conditions

Obesity Behavior Body Weight Emotional Regulation Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Self-Control Signs and Symptoms Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Self-reported binge eating pathology (BES)

    Time frame: Baseline

    Binge Eating Scale

Secondary outcomes

  1. Self-reported anxiety and depression (HADS)

    Time frame: Baseline

    Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression

  2. Self-reported mindfulness skills (FFMQ)

    Time frame: Baseline

    Five Facets Mindfulness Questionnaire (version: 15 items): observe, describe, act with awareness, non-judgment, non-react

  3. Self-reported emotion regulation (CERQ)

    Time frame: Baseline

    Cognitive Emotional Regulation Questionnaire (2 subscales): adaptive regulation and non-adaptive regulation

  4. Self-reported eating patterns (TFEQ-R18)

    Time frame: Baseline

    Three Factor Eating Questionnaire (3 subscales): emotional eating, uncontrolled eating, restraint eating

  5. Self-reported impact of traumatic event (IES-R)

    Time frame: Baseline

    Impact of Event Scale revised version (3 subscales): avoidance, intrusion, hyperarousal

  6. Self-reported childhood trauma (CTQ)

    Time frame: Baseline

    Childhood Trauma Questionnaire (5 subscales): emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse

  7. Self-reported lifetime traumatic events (LEC-5)

    Time frame: Baseline

    Life Event Checklist (DSM-5)

  8. Body Mass Index (kg/m2)

    Time frame: Baseline

    BMI as measured by a physician

Other outcomes

  1. Sociodemographics and medical data

    Time frame: Baseline

    Form filled out by the participants

Sponsors and collaborators

Lead sponsor

University of Paris 5 - Rene Descartes

Other

Collaborators

  • European Georges Pompidou Hospital

Registry information

Official study title

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

Acronym: TrOma

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 4, 2017
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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