Influence of the COVId-19 Pandemic on STRESS and Eating H... | NCT04621084

Studies
Influence of the COVId-19 Pandemic on STRESS and Eating Habits

NCT04621084

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Nov 9, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Nutrition

Interventions

Eating habits

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Actual

Primary Completion Date

Dec 31, 2025Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Nov 5, 2020

First Submission Date that Met QC Criteria

Nov 6, 2020

First Posted Date

Nov 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 6, 2020

Last Update Posted Date

Nov 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Coronavirus has caused containment of more than a third of the world's population. Containment can drastically change lifestyle habits, including eating habits such as the number of meals, meal times or their composition. However, there is currently no data on the influence of confinement on eating habits.

Detailed Description

This is an observational study by REDCap questionnaire® via a flyer deposited in the waiting room of the COVID screening centres. No incentive to complete the questionnaire will be made.

The self-administered questionnaire will assess stress, changes in eating habits, and relationships with socio-demographic or lifestyle factors.

This questionnaire includes 9 specific questions on nutrition and 40 general questions.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Eating habits	Behavioral	Questionnary online

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Stress measures	Attitudes and stress related to screening procedure will be measured via questionnaire	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Nutrition	Eating habits will be measured via questionnaire	Day 1

Other Outcomes

Measure	Description	Time Frame
Sociodemographic characteristics	Age, gender, qualification, personal work status, ethnicity, life characteristics and stress will be assessed by questionnaires	Day 1

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All volunteers who are screened

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lise Laclautre	Contact	0473754963		promo_interne_drci@chu-clermontferrand.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clermont-Ferrand University Hospital	Recruiting	Clermont-Ferrand	AURA	63000	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D005247	Feeding Behavior

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided