Type1diabetesNCT03588234
Food Literacy and Type 1 Diabetes
An observational study of Type1diabetes, run by McGill University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Type1diabetes
- How many people
- 427 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jun 2018to 31 Aug 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 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults (18-29) with type 1 diabetes.
Who may be able to join
- Type 1 diabetes
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Type1diabetes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food literacy level
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.
Measured: Baseline
Secondary outcomes (4)
Fruit and vegetable consumption
On a daily basis, how many servings of fruits/vegetables do you eat on average?
Measured: Baseline
Hypoglycaemia frequency
Overall, during a usual week, how many times does your blood sugar go low (lower than 4,0 mmol/L)?
Measured: Baseline
Self-reported A1c
What was your last hemoglobin A1c result?
Measured: Baseline
Fast food consumption
In the last week, how many times have you eaten at a fast food restaurant?
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start28 Jun 2018
- Primary completion1 Mar 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 427 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Québec
- Responsible party
- Principal investigator, Anne-Sophie Brazeau, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588234
- Sponsor's protocol ID
- 43-0618
- Status last verified
- Sep 2020
- First submitted
- 4 Jul 2018
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24462490Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.
PubMed 24070926Fitzgerald 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.
PubMed 26769757Grea 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.
PubMed 28912107Statistics Canada, Canadian Community Health Survey (CCHS): Food skills - mechanical skills and food conceptualization. 2013: Ottawa.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Literacy and Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03588234
- Acronym / sponsor ID
- 43-0618
- Conditions
- Type1diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 427 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Diabetes Québec
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 17 Jul 2018 (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 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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults (18-29) with type 1 diabetes.
Key inclusion criteria (1 listed)
- Type 1 diabetes
Key exclusion criteria (0 listed)
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
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.
4 secondary outcomes
Fruit and vegetable consumption
Time frame: Baseline
Hypoglycaemia frequency
Time frame: Baseline
Self-reported A1c
Time frame: Baseline
Fast food consumption
Time frame: Baseline
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 16 Sep 2020.
- Background: PubMed 24462490Vidgen 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.
- Background: PubMed 24070926Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.
- Background: PubMed 26769757Fitzgerald 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.
- Background: PubMed 28912107Grea 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.
- BackgroundStatistics Canada, Canadian Community Health Survey (CCHS): Food skills - mechanical skills and food conceptualization. 2013: Ottawa.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Type1diabetes, run by McGill 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 1 inclusion and 0 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 16 Sep 2020. 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?
Food literacy level (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03588234, which also lists 5 linked publications.
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 16 Sep 2020.