Bariatric Surgery CandidateACRoBATNCT03976674
A Preoperative Cognitive Behavioural Therapy Program Based on Self-determination Theory for Bariatric Surgery Candidates
A study testing Cognitive Behavioural Therapy (CBT) in people with Bariatric Surgery Candidate and Obesity, run by Lille Catholic University at 1 site in France.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery Candidate, Obesity
- What is being tested?
- Cognitive Behavioural Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2018to 10 Sep 2020
- Phase
- Interventional
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Low level of comprehension of French
- Pregnant women
- Patient under guardianship or curatorship.
Trial locations and contacts
1 site in 1 country.
France1 site
• Lille Catholic University Hospital Group, Saint Philibert Hospital
Lomme, Haits de France, 59
About this study
Official title: 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
- Conditions
- Bariatric Surgery Candidate, Obesity
- Being tested
- Cognitive Behavioural Therapy (CBT)
- Keywords
- Bariatric Surgery Candidate, Cognitive and Behavioural Emotional Therapies, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT)Behavioural
5 group sessions (2h30/session) before the surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients in preparation for bariatric surgery | Experimental | Patients in preparation for bariatric surgery in the endocrinology department will follow a cognitive behavioural therapy Receives: Behavioral: Cognitive Behavioural Therapy (CBT) |
| Control group | No intervention | Standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination-Questionnaire (EDE-Q) score
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
Measured: One year after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start5 Feb 2018
- Primary completion5 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bariatric Surgery CandidateStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cynthia CHEROUTRE, Study chair, GHICL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976674
- Sponsor's protocol ID
- RC-P0061
- Acronym
- ACRoBAT
- Status last verified
- Dec 2025
- First submitted
- 4 Jun 2019
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheroutre C, Guerrien A, Rousseau A. Contributing of Cognitive-Behavioral Therapy in the Context of Bariatric Surgery: a Review of the Literature. Obes Surg. 2020 Aug;30(8):3154-3166. doi: 10.1007/s11695-020-04627-9.
PubMed 32440777
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03976674
- Acronym / sponsor ID
- ACRoBAT / RC-P0061
- Conditions
- Bariatric Surgery Candidate, Obesity
- Keywords
- Bariatric Surgery Candidate, Cognitive and Behavioural Emotional Therapies, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 6 Jun 2019 (actual)
- 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 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients in preparation for bariatric surgery | Experimental | Behavioral: Cognitive Behavioural Therapy (CBT)Patients in preparation for bariatric surgery in the endocrinology department will follow a cognitive behavioural therapy |
| Control group | No intervention | –Standard practice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Low level of comprehension of French
- Pregnant women
- Patient under guardianship or curatorship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy (CBT)5 group sessions (2h30/session) before the surgery | Behavioural | Patients in preparation for bariatric surgery |
Primary outcome
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
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 24 Dec 2025.
- Results publication: PubMed 32440777Cheroutre C, Guerrien A, Rousseau A. Contributing of Cognitive-Behavioral Therapy in the Context of Bariatric Surgery: a Review of the Literature. Obes Surg. 2020 Aug;30(8):3154-3166. doi: 10.1007/s11695-020-04627-9.
- Individual participant dataSharing planned: No
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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.
Cynthia CHEROUTRE study chair
GHICL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy (CBT) in people with Bariatric Surgery Candidate and Obesity, run by Lille Catholic University 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 5 inclusion and 3 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 24 Dec 2025. 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?
Eating Disorder Examination-Questionnaire (EDE-Q) score (time frame: One year after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976674, which also lists 1 linked publication.
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 24 Dec 2025.