NutritionCOVISTRESSNutrNCT04621084
Influence of the COVId-19 Pandemic on STRESS and Eating Habits
An observational study of Nutrition, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutrition
- What is being tested?
- Eating habits
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All volunteers
Who may be able to join
- All volunteers who are screened
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clermont-Ferrand University Hospital
Clermont-Ferrand, AURA, 63000
lise laclautre, 0473754963, promo_interne_drci@chu-clermontferrand.fr
Frederic DUTHEIL
About this study
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.
Read the 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.
- Conditions
- Nutrition
- Being tested
- Eating habits
- Keywords
- nutrition, Covid-19, Eating habits, Stress
- Medical subject headings
- COVID-19, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eating habitsBehavioural
Questionnary online
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress measures
Attitudes and stress related to screening procedure will be measured via questionnaire
Measured: Day 1
Secondary outcomes (1)
Nutrition
Eating habits will be measured via questionnaire
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start1 Apr 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621084
- Sponsor's protocol ID
- 2020 COVISTRESS NUTRITION
- Acronym
- COVISTRESSNutr
- Status last verified
- Nov 2020
- First submitted
- 5 Nov 2020
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the COVId-19 Pandemic on STRESS and Eating Habits
- ClinicalTrials.gov ID
- NCT04621084
- Acronym / sponsor ID
- COVISTRESSNutr / 2020 COVISTRESS NUTRITION
- Conditions
- Nutrition
- Keywords
- nutrition, Covid-19, Eating habits, Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All volunteers
Key inclusion criteria (1 listed)
- All volunteers who are screened
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eating habitsQuestionnary online | Behavioural | – |
Primary outcome
Stress measures
Time frame: Day 1
Attitudes and stress related to screening procedure will be measured via questionnaire
1 secondary outcome
Nutrition
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stress measures (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.