Eating HabitsNCT04371848
Impact of the COVID-19 Pandemic on Diet Quality and Food Insecurity: a NutriQuébec Sub-study
An observational study of Eating Habits, run by Laval University at 1 site in Canada.
Trial summary
The unprecedented confinement and social distancing rules imposed by the fight against COVID-19 has forced the majority of the population worldwide to stay home for periods of time ranging from weeks to months. Eating habits are undoubtedly perturbed during this period, with consequential impact on food security. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Habits
- How many people
- 2,465 participants
- Where
- 1 siteCanada
- Study dates
- 16 Apr 2020to 7 May 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults living in the province of Québec (Canada)
Who may be able to join
- Adults aged 18 and over with a residential address in Québec (Canada)
- Be able to read and understand French or English
- Have access to Internet (with a computer, electronic tablet or cell phone)
- Have an active email address
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of the COVID-19 Pandemic on Diet Quality and Food Insecurity Among Adults From the Province of Québec in Canada: a NutriQuébec Sub-study
The unprecedented confinement and social distancing rules imposed by the fight against COVID-19 has forced the majority of the population worldwide to stay home for periods of time ranging from weeks to months. Eating habits are undoubtedly perturbed during this period, with consequential impact on food security. Therefore, the primary aim of this NutriQuébec sub-study is to document the impacts of the COVID-19 pandemic on diet quality and food insecurity of adults in the province of Québec in Canada.
NutriQuébec is a web-based prospective cohort study launched in June 2019 whose primary aim is to provide data for the evaluation of the Government Health Prevention Policy on the Québec population's eating habits over the years (NCT04140071). Participants of NutriQuébec are invited to complete on a web-based platform nine core questionnaires on a yearly basis. Questionnaires assess several dimensions related to lifestyle, including eating habits and physical activity habits, as well as a large number of personal characteristics and global health status.
For the purpose of this sub-study, NutriQuebec will invite the 2465 active participants who completed the first-year questionnaires prior to the COVID-19 pandemic to fill out again those questionnaires during the peak period of the confinement period in April and May, 2020. This NutriQuébec sub-study will provide invaluable data on how the COVID-19 pandemic impacts diet quality and food insecurity of adults in the province of Québec.
Read the detailed description
The 2465 active participants of NutriQuébec who completed the first-year questionnaires prior to the COVID-19 pandemic will be invited to provide informed consent to participate in this sub-study. Once having consented, participants will be invited to complete the core questionnaires by logging into their personal and secured account. Participants will have a three-week period to complete the questionnaires, from April 16 to May 7, 2020.
Core questionnaires in NutriQuébec assess lifestyle habits including eating habits, physical activity habits, sleep quality, tobacco, alcohol and drug habits as well as pandemic behaviors, personal characteristics, food insecurity, health status and health-related quality of life. Most of these questionnaires are based on a one-month recall timeframe, with the exception of the eating habits questionnaires, which is in the form of repeated 24-h recall. For the purpose of this NutriQuébec substudy, questionnaires were adapted to focus on habits during the last 7 days of questionnaire completion, to reflect more specifically the confinement period.
- Conditions
- Eating Habits
- Keywords
- Eating habits, Web-based prospective cohort study, Lifestyle habits, Diet quality, COVID-19, Food insecurity, Health
- Medical subject headings
- Feeding Behavior, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in diet quality
Diet quality during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measured: 0 to 11 months
Change in food insecurity
Food insecurity during the study period will be assessed using the series of questions of the Household Food Security Survey Module from the Canadian Community Health Survey (CCHS)-2017
Measured: 0 to 11 months
Secondary outcomes (8)
Change in intake of sodium
Intake of sodium during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measured: 0 to 11 months
Change in intake of sugar
Intake of sugar during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measured: 0 to 11 months
Change in intake of saturated fat
Intake of saturated fat during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measured: 0 to 11 months
Change in intake of vegetables and fruits
Intake of vegetables and fruits during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measured: 0 to 11 months
Change in intake of dairy products
Intake of dairy products during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Measured: 0 to 11 months
Change in physical activity
Physical activity during the study period will be assessed primarily using the EPIC-Norfolk Work and leisure time physical activity questionnaire, which categorizes participants into one of 4 groups based on physical activity at work and during leisure time: 1- Inactive, 2- Moderately inactive, 3- moderately active, 4- Active.
Measured: 0 to 11 months
Change in sleep quality
Sleep quality during the study period will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire with a score varying between 0 and 21; lower score indicates a better sleep quality.
Measured: 0 to 11 months
Change in health-related quality of life
Quality of life during the study period will be assessed using the Short form (SF)-36 health-related quality of life questionnaire, which yields eight subscale scores that are analyzed individually: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Each subscale has a score varying between 0 and 100; higher scores indicate a better quality of life for each individual subscale.
Measured: 0 to 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start16 Apr 2020
- Primary completion7 May 2020
- Study completion7 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating HabitsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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
- Prospective
- Enrolment
- 2,465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoît Lamarche, Principal investigator, University Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371848
- Sponsor's protocol ID
- 2018-042Phase IIA6/09-04-2020
- Status last verified
- Aug 2024
- First submitted
- 22 Apr 2020
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the COVID-19 Pandemic on Diet Quality and Food Insecurity Among Adults From the Province of Québec in Canada: a NutriQuébec Sub-study
- ClinicalTrials.gov ID
- NCT04371848
- Acronym / sponsor ID
- 2018-042Phase IIA6/09-04-2020
- Conditions
- Eating Habits
- Keywords
- Eating habits, Web-based prospective cohort study, Lifestyle habits, Diet quality, COVID-19, Food insecurity, Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,465 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 7 May 2020 (actual)
- Study completion
- 7 May 2020 (actual)
- First posted
- 1 May 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 unprecedented confinement and social distancing rules imposed by the fight against COVID-19 has forced the majority of the population worldwide to stay home for periods of time ranging from weeks to months. Eating habits are undoubtedly perturbed during this period, with consequential impact on food security. Therefore, the primary aim of this NutriQuébec sub-study is to document the impacts of the COVID-19 pandemic on diet quality and food insecurity of adults in the province of Québec in Canada.
NutriQuébec is a web-based prospective cohort study launched in June 2019 whose primary aim is to provide data for the evaluation of the Government Health Prevention Policy on the Québec population's eating habits over the years (NCT04140071). Participants of NutriQuébec are invited to complete on a web-based platform nine core questionnaires on a yearly basis. Questionnaires assess several dimensions related to lifestyle, including eating habits and physical activity habits, as well as a large number of personal characteristics and global health status.
For the purpose of this sub-study, NutriQuebec will invite the 2465 active participants who completed the first-year questionnaires prior to the COVID-19 pandemic to fill out again those questionnaires during the peak period of the confinement period in April and May, 2020. This NutriQuébec sub-study will provide invaluable data on how the COVID-19 pandemic impacts diet quality and food insecurity of adults in the province of Québec.
Detailed description
The 2465 active participants of NutriQuébec who completed the first-year questionnaires prior to the COVID-19 pandemic will be invited to provide informed consent to participate in this sub-study. Once having consented, participants will be invited to complete the core questionnaires by logging into their personal and secured account. Participants will have a three-week period to complete the questionnaires, from April 16 to May 7, 2020.
Core questionnaires in NutriQuébec assess lifestyle habits including eating habits, physical activity habits, sleep quality, tobacco, alcohol and drug habits as well as pandemic behaviors, personal characteristics, food insecurity, health status and health-related quality of life. Most of these questionnaires are based on a one-month recall timeframe, with the exception of the eating habits questionnaires, which is in the form of repeated 24-h recall. For the purpose of this NutriQuébec substudy, questionnaires were adapted to focus on habits during the last 7 days of questionnaire completion, to reflect more specifically the confinement period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults living in the province of Québec (Canada)
Key inclusion criteria (4 listed)
- Adults aged 18 and over with a residential address in Québec (Canada)
- Be able to read and understand French or English
- Have access to Internet (with a computer, electronic tablet or cell phone)
- Have an active email address
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.
Primary outcome
Change in diet quality
Time frame: 0 to 11 months
Diet quality during the study period will be assessed using dietary intake data from the average of 3 validated Web-based 24-hour recalls (R24W)
Change in food insecurity
Time frame: 0 to 11 months
Food insecurity during the study period will be assessed using the series of questions of the Household Food Security Survey Module from the Canadian Community Health Survey (CCHS)-2017
8 secondary outcomes
Change in intake of sodium
Time frame: 0 to 11 months
Change in intake of sugar
Time frame: 0 to 11 months
Change in intake of saturated fat
Time frame: 0 to 11 months
Change in intake of vegetables and fruits
Time frame: 0 to 11 months
Change in intake of dairy products
Time frame: 0 to 11 months
Change in physical activity
Time frame: 0 to 11 months
Change in sleep quality
Time frame: 0 to 11 months
Change in health-related quality of life
Time frame: 0 to 11 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Benoît Lamarche principal investigator
University Laval
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 Eating Habits, run by Laval University at 1 site in Canada.
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 4 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: finished, as of the sponsor's last update on 20 Aug 2024. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in diet quality (time frame: 0 to 11 months). The study lists 2 primary outcomes in all. 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 20 Aug 2024.