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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03847584
Other study ID # 2018-042 A-2/10-09-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 11, 2018
Est. completion date October 20, 2018

Study information

Verified date February 2019
Source Laval University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Populations with low socioeconomic status (SES) are more likely to develop diseases across lifespan and are frequently underrepresented in large cohort studies. The aim of this study is to examine beliefs, preferences and concerns towards participating in an e-cohort prospective study on nutrition (NutriQuébec) among this population.

A cross-sectional survey will be completed by 418 adults in the Province of Québec (Canada), including individuals with low SES (high school or less and gross annual household income < $55,000 canadian). The survey is based on the Theory of Planned Behaviour and assesses intention to participate in NutriQuébec as well as attitude, subjective norm, and perceived behavioural control. The survey also assesses preferences regarding the recruitment.


Description:

A cross-sectional survey will be completed by 418 participants from several administrative regions of Québec (Canada). A special effort will be made to recruit men and women with low socioeconomic status (SES), but without rejecting adults from middle/high SES. First, 325 adults from low SES (high school or less and gross annual household income < $55,000 canadian) and from several administrative regions of Québec will be identified by a survey firm. In addition, an e-mail mailing list from the Institute of Nutrition and Functional Food (INAF, Laval University) will be used to distribute the recruitment ad to complete our sample (n=93 from all SES).

The survey is based on the Theory of Planned Behaviour and assesses intention to participate in NutriQuébec as well as attitude, subjective norm, and perceived behavioural control. The salient beliefs underlying the determinants of individual's intention to participate in the NutriQuébec study most frequently cited in the focus groups (from a preliminary elicitation study: 2018-042 A-1/18-05-2018) were used to develop the survey questions. The survey also assesses the preferences regarding the recruitment. Sociodemographic questions are also asked.


Recruitment information / eligibility

Status Completed
Enrollment 418
Est. completion date October 20, 2018
Est. primary completion date October 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult (18 years of age or older)

- Living in the province of Québec

- Have access to the Internet and have an active email address

- Be able to answer questionnaires in French

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Survey
The survey is based on the Theory of Planned Behaviour and assesses intention to participate in NutriQuébec as well as attitude, subjective norm, and perceived behavioural control. The salient beliefs underlying the determinants of individual's intention to participate in the NutriQuébec study most frequently cited in the focus groups (from a preliminary elicitation study: 2018-042 A-1/18-05-2018) were used to develop the survey questions. The survey also assesses the preferences regarding the recruitment. Sociodemographic questions are also asked.

Locations

Country Name City State
Canada Laval University Québec

Sponsors (1)

Lead Sponsor Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary The intention to participate to the NutriQuébec study will be assessed by a questionnaire based on the Theory of Planned Behaviour. Intention will be calculated as the mean of three questions on a five point bipolar Likert scale. The three questions are: 1) I intend to participate in the NutriQuébec study : 1=very unlikely, 2=rather unlikely, 3=neither likely nor unlikely, 4=rather likely, 5=very likely; 2) The chances that I participate in the NutriQuébec study are : 1=very small, 2=rather small, 3=neither high nor small, 4=rather high, 5=very high; 3) I will participate in the NutriQuébec study: 1=very unlikely, 2=rather unlikely, 3=neither likely nor unlikely, 4=rather likely, 5=very likely). Thus, the mean score for intention ranges from 1 to 5, with higher values reflecting a greater likelihood for participation in the NutriQuébec study. Baseline
Primary The attitude related to a hypothetical participation in the NutriQuébec study will be assessed by a questionnaire based on the Theory of Planned Behaviour. The attitude will be calculated as the mean of three questions on a five point bipolar Likert scale. The three questions are: 1) For me, participating in the NutriQuébec study would be...: 1=very unpleasant, 2=rather unpleasant, 3=neither pleasant nor unpleasant, 4=rather pleasant, 5=very pleasant; 2) For me, participating in the NutriQuébec study would be...: 1=very useless, 2=rather useless, 3=neither useful nor useless, 4=rather useful, 5=very useful; 3) For me, participating in the NutriQuébec study would be…: 1=very unsatisfactory, 2=rather unsatisfactory, 3=neither satisfactory nor unsatisfactory, 4=rather satisfactory, 5=very satisfactory. Thus, the mean score for attitude ranges from 1 to 5, with higher values reflecting a more positive attitude towards a participation in the NutriQuébec study. Baseline
Primary The subjective norm related to a hypothetical participation in the NutriQuébec study will be assessed by a questionnaire based on the Theory of Planned Behaviour. The subjective norm will be calculated as the mean of three questions on a five point bipolar Likert scale. The three questions are: 1) The people most important to me might think that I should participate in the NutriQuébec study:1=very unlikely, 2=rather unlikely, 3=neither likely nor unlikely, 4=rather likely, 5=very likely; 2) Many people I know may be interested in participating in the NutriQuébec study: 1=very unlikely, 2=rather unlikely, 3=neither likely nor unlikely, 4=rather likely, 5=very likely; 3) If I participated in the NutriQuébec study, most people who are important to me could...: 1= strongly disapprove, 2= slightly disapprove, 3=neither approve nor disapprove, 4= slightly approve, 5=strongly approve. Thus, the mean score for the subjective norm ranges from 1 to 5, with higher values representing perceptions that important others expect the participant to participating in the NutriQuébec study. Baseline
Primary The perceived behavioural control related to a hypothetical participation in the NutriQuébec study will be assessed by a questionnaire based on the Theory of Planned Behaviour. The perceived behavioural control will be calculated by the mean of three questions on a five point bipolar Likert scale. The three questions are: 1) I feel able to participate in the NutriQuébec study: 1=very unlikely, 2=rather unlikely, 3=neither likely nor unlikely, 4=rather likely, 5=very likely; 2) I am confident that I can overcome any obstacles that may prevent me from participating in the NutriQuébec study: 1=very unlikely, 2=rather unlikely, 3=neither likely nor unlikely, 4=rather likely, 5=very likely; 3) For me, participating in the NutriQuébec study would be....: 1=very difficult, 2=rather difficult, 3=neither easy nor difficult, 4=rather easy, 5=very easy. Thus, the mean score for the perceived behavioural control ranges from 1 to 5, with higher values representing a greater perceived behavioural control towards a participation in the NutriQuébec study. Baseline
Primary The determinants to the intention to participate to the NutriQuébec study will be assessed by a questionnaire based on the Theory of Planned Behaviour. Determinants to the intention to participate in the NutriQuébec study will be identified with a multiple linear regression using constructs that will be found significant in influencing the intention to participate in the NutriQuébec study (e.g. attitude, subjective norm, perceived behavioural control). Baseline
Secondary The preferences about the recruitment in the NutriQuébec study will be assessed by a questionnaire The preferences about the recruitment in the NutriQuébec study will be assessed by a questionnaire. The question is: By which means of communication would advertising about the NutriQuébec study be most likely to capture your attention?: 1=Television, 2=Social networks (Facebook, Instagram, YouTube, etc.), 3=The Internet (other than social networks), 4=Newspapers, 5=Posters in public places (hospitals, community centres, etc.), 6=Flyers, 7=Postal mail, 8=None. Baseline
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