NCT04431284

Brief Summary

COVID-19 lockdown presents particular challenges for people living with obesity. Indeed during this period, the lifestyle was deeply modified: diet, activity, and sleep behaviours, home office, take care of child, social distancing... All of these modifications may have led to stress and anxiety. It has been previously demonstrated that high perceived stress levels are correlated with high preference for sweet and fat foods . In this context caution would be exercised in obese patients especially those with binge eating disorders. Indeed binge eating disorder is characterized by compulsive overeating or consuming abnormal amounts of food while feeling unable to stop and a loss of control. And one key trigger of binge eating disorder is stress and anxiety. Thus, patients with binge eating disorders may have been more sensitive to the impact of lockdown and thus urgently would require appropriated care management. The main objective is to compare the eating behaviour between obese patients with or without binge eating disorders. The second objective is to compare the weight evolution between the two groups before and after the lockdown. To reach these objectives, the scientific team of the CIO project proposes to contact by phone and e-mail obese patients (with or without binge eating disorders) who have been hospitalized for their obesity disease before the start of the lockdown in the Endocrinology department of the Lyon Hospital. The patients will be asked to fill in several questionnaires (using an online tool) allowing to evaluate their mood, anxiety, eating behaviour, binge eating disorders… during the lockdown. The results of these questionnaires will be compared to those collected during their hospitalisation before the lockdown. The hypothesis is that participants suffering from binge eating disorder will have more sever eating behaviour perturbations as higher level of stress, anxiety, depressive symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

June 10, 2020

Last Update Submit

January 29, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Comparison of the BMI (kg/m²) evolution between the two groups

    Day 21

  • Score comparison of the Dutch Eating Behavior Questionnaire

    Day 21

Study Arms (2)

Obese patients with binge eating disorders

Severely obese patients (with or without binge eating disorders, Binge Eating Sclae \>= 16) who have been hospitalized for obesity assessment before the start of the lockdown in the Endocrinology department of the Lyon Hospital

Other: Questionnaires

Obese patients without binge eating disorders

Severely obese patients (with or without binge eating disorders, Binge Eating Sclae \>= 16) who have been hospitalized for obesity assessment before the start of the lockdown in the Endocrinology department of the Lyon Hospital

Other: Questionnaires

Interventions

The two groups (23 patients per group) will be contacted by phone or e-mail to participate to the CIO study. Once their agreement received, each patient will be asked to complete the same set of online questionnaires : weight, HAD (Hospital Anxiety and Depression scale), BES (Binge Eating Scale), YFAS (Yale Food Addiction Scale), DEBQ (Dutch Eating Behavior Questionnaire), IPAQ (International physical activity questionnaire), COVID 19 questionnaire Penn State, items from the Do-It questionnaire, general questions on the lifestyle during the lockdown (custom questionnaire), COVID stress evaluation (custom questionnaire)

Obese patients with binge eating disordersObese patients without binge eating disorders

Eligibility Criteria

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

Obese patients with or without binge eating disorders

You may qualify if:

  • severely obese patients

You may not qualify if:

  • patients do not experiment the full lockdown period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Intégré de l'obésité de Lyon / HCL

Pierre-Bénite, 69495, France

Location

Related Publications (1)

  • Torres SJ, Nowson CA. Relationship between stress, eating behavior, and obesity. Nutrition. 2007 Nov-Dec;23(11-12):887-94. doi: 10.1016/j.nut.2007.08.008. Epub 2007 Sep 17.

    PMID: 17869482BACKGROUND

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Emmanuel DISSE, MD

    Centre Intégré de l'obésité de Lyon / HCL

    PRINCIPAL INVESTIGATOR
  • Martine LAVILLE, MD

    Centre Intégré de l'obésité de Lyon / HCL

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 16, 2020

Study Start

June 16, 2020

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations