- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04431284
Impact of COVID-19 Lockdown on Obesity and Eating Behaviors (CIO)
Impact of COVID-19 Lockdown on Severely Obese Patients With or Without Binge Eating Behaviors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Pierre-Bénite, France, 69495
- Centre Intégré de l'obésité de Lyon / HCL
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- severely obese patients
Exclusion Criteria:
- patients do not experiment the full lockdown period
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
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 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
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Comparison of the BMI (kg/m²) evolution between the two groups
Time Frame: Day 21
|
Day 21
|
|
Score comparison of the Dutch Eating Behavior Questionnaire
Time Frame: Day 21
|
Day 21
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Emmanuel DISSE, MD, Centre Intégré de l'obésité de Lyon / HCL
- Principal Investigator: Martine LAVILLE, MD, Centre Intégré de l'obésité de Lyon / HCL
Publications and helpful links
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
- 69HCL20_0516
- 2020-A01616-33 (OTHER: ID-RCB)
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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