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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03976674
Other study ID # RC-P0061
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 5, 2018
Est. completion date September 10, 2020

Study information

Verified date February 2024
Source Lille Catholic University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date September 10, 2020
Est. primary completion date September 5, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cognitive Behavioural Therapy (CBT)
5 group sessions (2h30/session) before the surgery

Locations

Country Name City State
France • Lille Catholic University Hospital Group, Saint Philibert Hospital Lomme Haits De France

Sponsors (1)

Lead Sponsor Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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