NCT03976674

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 5, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2020

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2020

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

June 4, 2019

Last Update Submit

December 18, 2025

Conditions

Keywords

Bariatric Surgery CandidateCognitive and Behavioural Emotional TherapiesObesity

Outcome Measures

Primary Outcomes (1)

  • 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

    One year after therapy

Study Arms (2)

Patients in preparation for bariatric surgery

EXPERIMENTAL

Patients in preparation for bariatric surgery in the endocrinology department will follow a cognitive behavioural therapy

Behavioral: Cognitive Behavioural Therapy (CBT)

Control group

NO INTERVENTION

Standard practice

Interventions

5 group sessions (2h30/session) before the surgery

Patients in preparation for bariatric surgery

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patient starting a preparation for bariatric surgery in the endocrinology department at St Philibert Hospital
  • ≤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

You may not qualify if:

  • Low level of comprehension of French
  • Pregnant women
  • Patient under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

• Lille Catholic University Hospital Group, Saint Philibert Hospital

Lomme, Haits de France, 59, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Cynthia CHEROUTRE

    GHICL

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 6, 2019

Study Start

February 5, 2018

Primary Completion

September 5, 2020

Study Completion

September 10, 2020

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations