- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04218097
Food Addiction and Follow-up in Subjects With Obesity (ADDICTAL)
Impact of Follow-up in Subjects With Obesity and Food Addiction
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Pierre-Bénite, France, 69310
- Service Endocrinologie, Hôpital Lyon Sud,
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Obese patients grade 2 and 3
- Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018
- Over 18 years of age
- Not objecting to its participation
Exclusion Criteria:
- No understanding of French
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Addict patients
Obese type 2 and 3 with food addict according to the Yale Food Addiction Scale (YFAS) questionnaire. Cohort design: identification of patients treated in hospital for obesity assessment over the period 1 January 2017 to 1 January 2018 whose addictive or non-addictive status was characterised by the YFAS questionnaire. To talk about food addiction, the person must have at least 3 out of 7 positive criteria AND also meet the "marked suffering" criterion. |
Monitoring - data collection: Sending of an information form and the study questionnaire, the YFAS and Hospital Anxiety and Depression (HAD) scale by post within a follow-up period of 24 to 36 months.
With a stamped envelope for the answer and a telephone reminder if necessary.
|
Control patients
Obese type 2 and 3, non food addict Cohort design: identification of patients treated in hospital for obesity assessment over the period 1 January 2017 to 1 January 2018 whose addictive or non-addictive status was characterised by the YFAS questionnaire.
To talk about food addiction, the person must have at least 3 out of 7 positive criteria AND also meet the "marked suffering" criterion.
|
Monitoring - data collection: Sending of an information form and the study questionnaire, the YFAS and Hospital Anxiety and Depression (HAD) scale by post within a follow-up period of 24 to 36 months.
With a stamped envelope for the answer and a telephone reminder if necessary.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight change: difference between the current weight reported in a questionnaire and the weight measured at the end of hospitalization
Time Frame: month 36
|
Evaluate the weight evolution of patients according to their addictive or non-addictive nature, 24-36 months after their discharge from hospital, in Endocrinology for initial obesity assessment.
|
month 36
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Martine LAVILLE, PR, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL19_0401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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