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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04371848
Other study ID # 2018-042Phase IIA6/09-04-2020
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2020
Est. completion date May 7, 2020

Study information

Verified date March 2021
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 2465
Est. completion date May 7, 2020
Est. primary completion date May 7, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Canada Université Laval Québec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 0 to 11 months
Primary 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 0 to 11 months
Secondary 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) 0 to 11 months
Secondary 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) 0 to 11 months
Secondary 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) 0 to 11 months
Secondary 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) 0 to 11 months
Secondary 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) 0 to 11 months
Secondary 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. 0 to 11 months
Secondary 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. 0 to 11 months
Secondary 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. 0 to 11 months
See also
  Status Clinical Trial Phase
Recruiting NCT04140071 - NutriQuébec: a Web-based Prospective Cohort Study to Monitor the Population's Eating Habits in the Province of Québec.
Not yet recruiting NCT04406701 - Ceres: Eating Habits Among Lebanese Nurses