Back to resultsA Preoperative Cognitive Behavioural Therapy Program Based on Self-determination Theory for Bariatric Surgery Candidates (ACRoBAT)
Primary Purpose
Bariatric Surgery Candidate, Obesity
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy (CBT)
Sponsored by
About this trial
This is an interventional supportive care trial for Bariatric Surgery Candidate focused on measuring Bariatric Surgery Candidate, Cognitive and Behavioural Emotional Therapies, Obesity
Eligibility Criteria
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.
Sites / Locations
- • Lille Catholic University Hospital Group, Saint Philibert HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Patients in preparation for bariatric surgery
Control group
Arm Description
Patients in preparation for bariatric surgery in the endocrinology department will follow a cognitive behavioural therapy
Standard practice
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03976674
Brief Title
A Preoperative Cognitive Behavioural Therapy Program Based on Self-determination Theory for Bariatric Surgery Candidates
Acronym
ACRoBAT
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 5, 2018 (Actual)
Primary Completion Date
September 5, 2020 (Anticipated)
Study Completion Date
December 5, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery Candidate, Obesity
Keywords
Bariatric Surgery Candidate, Cognitive and Behavioural Emotional Therapies, Obesity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients in preparation for bariatric surgery
Arm Type
Experimental
Arm Description
Patients in preparation for bariatric surgery in the endocrinology department will follow a cognitive behavioural therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard practice
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy (CBT)
Intervention Description
5 group sessions (2h30/session) before the surgery
Primary Outcome Measure Information:
Title
Eating Disorder Examination-Questionnaire (EDE-Q) score
Description
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
Time Frame
One year after therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AMELIE LANSIAUX, MD,PhD
Phone
03 20 22 57 41
Ext
33
Email
lansiaux.amelie@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Marine DESEUR
Ext
33
Email
deseur.marine@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia CHEROUTRE
Organizational Affiliation
GHICL
Official's Role
Study Chair
Facility Information:
Facility Name
• Lille Catholic University Hospital Group, Saint Philibert Hospital
City
Lomme
State/Province
Haits De France
ZIP/Postal Code
59
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia CHEROUTRE
Email
Cynthia.Cheroutre@ghicl.net
First Name & Middle Initial & Last Name & Degree
François DELECOURT, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Preoperative Cognitive Behavioural Therapy Program Based on Self-determination Theory for Bariatric Surgery Candidates
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