- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03588234
Food Literacy and Type 1 Diabetes
Study Overview
Status
Conditions
Detailed Description
Food literacy, the ability to plan and manage, select, prepare, and eat healthy foods, is a contemporary concept that provides a mechanism to understand the relationship between food-related knowledge, skills (ie., culinary competencies) and health behaviours and its impact on decision-making regarding dietary intake. The Diabetes Canada 2018 Clinical Practice Guidelines have recognized the role that food skills, a component of food literacy, have in managing glycemic control in patients living with type 1 diabetes. The guidelines also point out that no studies to date have investigated this skill level in the diabetic population and that interventions aimed at improving these skills would be beneficial for patients. There is therefore a need to assess the current level of food literacy among young adults with type 1 diabetes in order for future studies to develop targeted interventions.
The project will be cross-sectional in design and data will be collected with an on-line questionnaire. This questionnaire will allow for the evaluation of the level of food literacy in young adults with and without type 1 diabetes. The online survey software that will be utilized is Survey Monkey.
The study will be publicized through posts on Facebook©, Twitter©, and other forms of social media as well as on websites of collaborating diabetes organizations (see appendix B for a list of organizations). Participants interested in the study will be invited to go on the survey webpage. The first information presented will be the electronic consent form. If they have questions while reading the consent form, they will have the possibility to email or call a research assistant. Once they have agreed, they will be re-directed to the first question. The questionnaire takes approximately 20-25 minutes to complete. Completion of the questionnaire will trigger a page requesting them to email the study coordinator in order to be entered into the lottery for a chance to win an Ipad mini.
The survey includes sociodemographic questions as well as medical and diet history. For participants with diabetes, this includes duration since their diabetes onset, types of treatments (insulin), application of carbohydrate counting and the "Type 1 Diabetes Nutrition Knowledge Survey". Items on actual food intake, such as fruits and vegetables, and self-efficacy regarding cooking are included. Food literacy will be evaluated using the "Short food literacy questionnaire (SQLF)", a short 12-item questionnaire that we adapted for Canada. A score for the SQLF will be calculated (maximum 52 points) and participants will be categorized under 4 different groups (Inadequate, Problematic, Sufficient, Excellent). Participants categorized in inadequate or problematic will be considered having low food literacy. Three questions regarding cooking ability were taken from the Canadian Community Health Survey (CCHS). Current sources of information regarding diet and nutrition, as well as questions to assess knowledge of chronic diseases linked to dietary intake, the frequency at which participants cook their own meals vs. eat out vs. consume prepackaged meals as well as specific dietary habits such as skipping breakfast will also be investigated. Lastly, perceived food environment will be assessed by asking questions regarding where participants shop for food and their satisfaction regarding the selection of food available to them.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada, H9X3V9
- McGill University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Type 1 diabetes
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Type 1 diabetes
Individuals with type 1 diabetes (18-29 years old).
They must complete a questionnaire.
This group has approximately 26 extra questions to respond to compared to controls.
The extra questions pertain to their diabetes history as well as their knowledge regarding diabetes.
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Matched controls without Type 1 diabetes
Individuals without type 1 diabetes (18-29 years old).
They must complete the same questionnaire as the individuals with diabetes (without the diabetes-specific questions).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Food literacy level
Time Frame: Baseline
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Short food literacy questionnaire (SFLQ) score.
A score for the SQLF will be calculated (minimum score 7 points, maximum 52 points points) and participants will be categorized under 4 different groups (Inadequate, Problematic, Sufficient, Excellent).
Participants categorized in inadequate or problematic will be considered having low food literacy.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fruit and vegetable consumption
Time Frame: Baseline
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On a daily basis, how many servings of fruits/vegetables do you eat on average?
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Baseline
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Hypoglycaemia frequency
Time Frame: Baseline
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Overall, during a usual week, how many times does your blood sugar go low (lower than 4,0 mmol/L)?
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Baseline
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Self-reported A1c
Time Frame: Baseline
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What was your last hemoglobin A1c result?
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Baseline
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Fast food consumption
Time Frame: Baseline
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In the last week, how many times have you eaten at a fast food restaurant?
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Baseline
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Vidgen HA, Gallegos D. Defining food literacy and its components. Appetite. 2014 May;76:50-9. doi: 10.1016/j.appet.2014.01.010. Epub 2014 Jan 22.
- Fitzgerald JT, Funnell MM, Anderson RM, Nwankwo R, Stansfield RB, Piatt GA. Validation of the Revised Brief Diabetes Knowledge Test (DKT2). Diabetes Educ. 2016 Apr;42(2):178-87. doi: 10.1177/0145721715624968. Epub 2016 Jan 14.
- Diabetes Canada Clinical Practice Guidelines Expert Committee; Houlden RL. Introduction. Can J Diabetes. 2018 Apr;42 Suppl 1:S1-S5. doi: 10.1016/j.jcjd.2017.10.001. No abstract available.
- Grea Krause C, Beer-Borst S, Sommerhalder K, Hayoz S, Abel T. A short food literacy questionnaire (SFLQ) for adults: Findings from a Swiss validation study. Appetite. 2018 Jan 1;120:275-280. doi: 10.1016/j.appet.2017.08.039. Epub 2017 Sep 11.
- Statistics Canada, Canadian Community Health Survey (CCHS): Food skills - mechanical skills and food conceptualization. 2013: Ottawa.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43-0618
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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