NCT04218097

Brief Summary

Obesity is a chronic disease. Its prevalence, which is constantly increasing, as well as the morbidity and mortality caused, require the development of new treatments, particularly for associated eating disorders. Indeed, it has been shown that a participation of abnormalities of food addiction type behaviour was frequently found in patients hospitalized for obesity (25% of patients). These disorders require specific management if you want to achieve a good weight result. The aim of the study is to compare the weight evolution of patients with addiction-type disorder (addict) versus those without addiction (non-addict) as well as the management modalities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 6, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 30, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

2 months

First QC Date

December 19, 2019

Last Update Submit

August 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight change: difference between the current weight reported in a questionnaire and the weight measured at the end of hospitalization

    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

Study Arms (2)

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.

Other: Study questionnaire

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.

Other: Study questionnaire

Interventions

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.

Addict patientsControl patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obese patients grade 2 and 3, Hospitalized in Endocrinology A from January 1, 2017 to January 1, 2018

You may qualify if:

  • 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

You may not qualify if:

  • No understanding of French

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Endocrinologie, Hôpital Lyon Sud,

Pierre-Bénite, 69310, France

Location

MeSH Terms

Conditions

ObesityFeeding and Eating DisordersFood Addiction

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveMental DisordersBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Martine LAVILLE, PR

    Hospices Civils de Lyon

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2019

First Posted

January 6, 2020

Study Start

March 30, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations