- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03976674
A Preoperative Cognitive Behavioural Therapy Program Based on Self-determination Theory for Bariatric Surgery Candidates (ACRoBAT)
December 18, 2025 updated by: Lille Catholic University
Evaluation of a Preoperative Cognitive Behavioural Therapy (CBT) Program Based on Self-determination Theory for Bariatric Surgery Candidates : an Open-label Controlled, Randomized, Superiority Study
The objective of this study is to evaluate the impact of a pre-surgical intervention program based on Cognitive and Behavioural Emotional Therapies, on the degree of dietary restriction of patients who are candidates for bariatric surgery in order to increase the long-term effectiveness of this kind of surgery
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
94
Phase
- Not Applicable
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
-
-
Haits de France
-
Lomme, Haits de France, France, 59
- • Lille Catholic University Hospital Group, Saint Philibert Hospital
-
-
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 to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient starting a preparation for bariatric surgery in the endocrinology department at St Philibert Hospital
- 18 ≤Age≤60 years
- Patient meeting the criteria of the High Authority of Health (HAS) for the agreement of a bariatric treatment
- Patient affiliated to the social security
- Patient giving informed consent
Exclusion Criteria:
- Low level of comprehension of French
- Pregnant women
- Patient under guardianship or curatorship.
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Patients in preparation for bariatric surgery
Patients in preparation for bariatric surgery in the endocrinology department will follow a cognitive behavioural therapy
|
5 group sessions (2h30/session) before the surgery
|
|
No Intervention: Control group
Standard practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eating Disorder Examination-Questionnaire (EDE-Q) score
Time Frame: One year after therapy
|
The EDE-Q is a 28 item self-report questionnaire.
It concerns behaviors over a 28-day time period and retains the scoring system of 0-6: 0 = behaviour was absent and 6 = behaviour was present daily or to an extreme degree
|
One year after therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Cynthia CHEROUTRE, GHICL
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
February 5, 2018
Primary Completion (Actual)
September 5, 2020
Study Completion (Actual)
September 10, 2020
Study Registration Dates
First Submitted
June 4, 2019
First Submitted That Met QC Criteria
June 4, 2019
First Posted (Actual)
June 6, 2019
Study Record Updates
Last Update Posted (Estimated)
December 24, 2025
Last Update Submitted That Met QC Criteria
December 18, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC-P0061
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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