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Food Literacy and Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03588234
Recruitment Status : Recruiting
First Posted : July 17, 2018
Last Update Posted : August 13, 2019
Sponsor:
Collaborator:
Diabetes Québec
Information provided by (Responsible Party):
Anne-Sophie Brazeau, McGill University

Tracking Information
First Submitted Date July 4, 2018
First Posted Date July 17, 2018
Last Update Posted Date August 13, 2019
Actual Study Start Date June 28, 2018
Estimated Primary Completion Date December 21, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2018)
Food literacy level [ Time Frame: Baseline ]
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.
Original Primary Outcome Measures
 (submitted: July 4, 2018)
Food literacy level [ Time Frame: Baseline ]
Short food literacy questionnaire (SFLQ) score
Change History Complete list of historical versions of study NCT03588234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: July 4, 2018)
  • Fruit and vegetable consumption [ Time Frame: Baseline ]
    On a daily basis, how many servings of fruits/vegetables do you eat on average?
  • Hypoglycaemia frequency [ Time Frame: Baseline ]
    Overall, during a usual week, how many times does your blood sugar go low (lower than 4,0 mmol/L)?
  • Self-reported A1c [ Time Frame: Baseline ]
    What was your last hemoglobin A1c result?
  • Fast food consumption [ Time Frame: Baseline ]
    In the last week, how many times have you eaten at a fast food restaurant?
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Food Literacy and Type 1 Diabetes
Official Title Food Literacy and Type 1 Diabetes
Brief Summary The objective of the current study is to assess the prevalence of poor food literacy in young adults with type 1 diabetes through a national on-line survey. More specifically, the research question to be investigated as part of this project is: What is the current level of food literacy among young adults with type 1 diabetes? It is hypothesized that at least 50% of young adults with type 1 diabetes have a poor level of food literacy.
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 Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Young adults (18-29) with type 1 diabetes.
Condition Type1diabetes
Intervention Not Provided
Study Groups/Cohorts
  • 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.
  • 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 4, 2018)
778
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 21, 2019
Estimated Primary Completion Date December 21, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Type 1 diabetes
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 29 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Anne-Sophie Brazeau, RD, PhD 514-398-7848 anne-sophie.brazeau@mcgill.ca
Contact: Vanessa Maggio vanessa.maggio@mail.mcgill.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03588234
Other Study ID Numbers 43-0618
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Anne-Sophie Brazeau, McGill University
Study Sponsor McGill University
Collaborators Diabetes Québec
Investigators Not Provided
PRS Account McGill University
Verification Date August 2019