ObesityTrOmaNCT03009825
Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients
An observational study of Obesity, run by University of Paris 5 - Rene Descartes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with obesity
Who may be able to join
- Adults
- Obese (BMI >= 30)
- Recruited from the nutrition service of Hôpital Européen Georges-Pompidou
- Informed consent provided
Who cannot join
- PTSD symptoms (score > 33 ; PTSD Checklist-5)
- Bariatric surgery patients
- Difficulties to understand French language
- Patients under social protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Keywords
- Trauma exposure, Psychological distress, Emotion regulation, Mindfulness, Eating pathology
- Medical subject headings
- Obesity, Emotional Regulation
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported binge eating pathology (BES)
Binge Eating Scale
Measured: Baseline
Secondary outcomes (8)
Self-reported anxiety and depression (HADS)
Hospital Anxiety and Depression Scale (2 subscales): anxiety and depression
Measured: Baseline
Self-reported mindfulness skills (FFMQ)
Five Facets Mindfulness Questionnaire (version: 15 items): observe, describe, act with awareness, non-judgment, non-react
Measured: Baseline
Self-reported emotion regulation (CERQ)
Cognitive Emotional Regulation Questionnaire (2 subscales): adaptive regulation and non-adaptive regulation
Measured: Baseline
Self-reported eating patterns (TFEQ-R18)
Three Factor Eating Questionnaire (3 subscales): emotional eating, uncontrolled eating, restraint eating
Measured: Baseline
Self-reported impact of traumatic event (IES-R)
Impact of Event Scale revised version (3 subscales): avoidance, intrusion, hyperarousal
Measured: Baseline
Self-reported childhood trauma (CTQ)
Childhood Trauma Questionnaire (5 subscales): emotional neglect, emotional abuse, physical neglect, physical abuse, sexual abuse
Measured: Baseline
Self-reported lifetime traumatic events (LEC-5)
Life Event Checklist (DSM-5)
Measured: Baseline
Body Mass Index (kg/m2)
BMI as measured by a physician
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Paris 5 - Rene Descartes
- Sponsor type
- University, hospital or other
- Collaborators
- European Georges Pompidou Hospital
- Responsible party
- Principal investigator, Ruffault Alexis, University of Paris 5 - Rene Descartes
- Investigators
- Cécile Flahault, PhD, Study director, University Paris 5 - Rene DescartesSébastien Czernichow, Pr, Principal investigator, University Paris 5 - Rene Descartes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009825
- Sponsor's protocol ID
- EA4057-troma
- Acronym
- TrOma
- Status last verified
- Dec 2018
- First submitted
- 2 Jan 2017
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TrOma: A Cross-sectional Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients
- ClinicalTrials.gov ID
- NCT03009825
- Acronym / sponsor ID
- TrOma / EA4057-troma
- Conditions
- Obesity
- Keywords
- Trauma exposure, Psychological distress, Emotion regulation, Mindfulness, Eating pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Paris 5 - Rene DescartesUniversity, hospital or other
- Collaborators
- European Georges Pompidou Hospital
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with obesity
Key inclusion criteria (4 listed)
- Adults
- Obese (BMI >= 30)
- Recruited from the nutrition service of Hôpital Européen Georges-Pompidou
- Informed consent provided
Key exclusion criteria (4 listed)
- PTSD symptoms (score > 33 ; PTSD Checklist-5)
- Bariatric surgery patients
- Difficulties to understand French language
- Patients under social protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported binge eating pathology (BES)
Time frame: Baseline
Binge Eating Scale
8 secondary outcomes
Self-reported anxiety and depression (HADS)
Time frame: Baseline
Self-reported mindfulness skills (FFMQ)
Time frame: Baseline
Self-reported emotion regulation (CERQ)
Time frame: Baseline
Self-reported eating patterns (TFEQ-R18)
Time frame: Baseline
Self-reported impact of traumatic event (IES-R)
Time frame: Baseline
Self-reported childhood trauma (CTQ)
Time frame: Baseline
Self-reported lifetime traumatic events (LEC-5)
Time frame: Baseline
Body Mass Index (kg/m2)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Flahault, PhD study director
University Paris 5 - Rene Descartes
Sébastien Czernichow, Pr principal investigator
University Paris 5 - Rene Descartes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University of Paris 5 - Rene Descartes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported binge eating pathology (BES) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.