Impact of COVID-19 Lockdown on Obesity and Eating Behaviors

NCT ID: NCT04431284

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-16

Study Completion Date

2020-12-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feeding and Eating Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Questionnaires

Intervention Type OTHER

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

Questionnaires

Intervention Type OTHER

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Questionnaires

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)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* severely obese patients

Exclusion Criteria

* patients do not experiment the full lockdown period
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Emmanuel DISSE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Intégré de l'obésité de Lyon / HCL

Martine LAVILLE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Intégré de l'obésité de Lyon / HCL

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Intégré de l'obésité de Lyon / HCL

Pierre-Bénite, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17869482 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-A01616-33

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL20_0516

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.