Type 2 DiabetesNCT07058558
Community-integrated Nutrition Education to Prevent Type 2 Diabetes in Peel
A study testing Nutrition Education and Community Gardening in people with Type 2 Diabetes, run by University of Toronto at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to assess the effectiveness of an intervention that delivers nutrition education based on the Portfolio Diet on type-2 diabetes (T2D) risk factors among adults who are without chronic conditions, who have overweight and a high waist circumference plus one self-reported T2D risk… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Nutrition Education and Community Gardening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2025to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be in their 40s or older
- Must be a resident in the Peel region of the Greater Toronto Area
- Must not have any chronic conditions (that will impact participation in study)
- Must be overweight, have a high waist circumference plus one self-reported T2D risk factor (e.g. family history, non-white ethnicity, high blood pressure, high blood cholesterol, prediabetes)
- Must have a risk score of 21 or above using the CANrisk T2D screening tool (https://health.canada.ca/apps/canrisk-standalone/pdf/canrisk-en.pdf)
- Must not be participating in another trial
- Must have access to a smartphone or internet. (For participants who wish to join the study but do not have home internet/smart phone, the investigators will provide resources to participants such as locations/hours of public libraries and community centres, where they could access internet and/or an electronic device (i.e computers) to participate in the study).
Who cannot join
- Under the age of 40
- Not a resident in the Peel region of the Greater Toronto Area
- Has chronic conditions (that will impact participation in study)
- Not overweight, does not have a high waist circumference plus one self-reported T2D risk factor (e.g. family history, non-white ethnicity, high blood pressure, high blood cholesterol, prediabetes)
- Does not have a risk score of 21 or above using the CANrisk T2D screening tool (https://health.canada.ca/apps/canrisk-standalone/pdf/canrisk-en.pdf)
- Participating in another trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
University of Toronto Mississauga
Mississauga, Ontario (ON), L5L 1C6
Community garden spaces across peel
Toronto, Ontario
About this study
Official title: Increasing Knowledge, Reducing Risk: A Community- Integrated Nutrition Education Intervention to Prevent Type 2 Diabetes in Peel
The goal of this clinical trial is to assess the effectiveness of an intervention that delivers nutrition education based on the Portfolio Diet on type-2 diabetes (T2D) risk factors among adults who are without chronic conditions, who have overweight and a high waist circumference plus one self-reported T2D risk factor. The main questions it aims to answer include:
- What are the barriers and facilitators for effective implementation of the nutrition education intervention?
- What is the effectiveness of the intervention on T2D risk factors?
- What are implementation strategies for scaling up the intervention?
Participants will participate in a 12-month lifestyle intervention comprised of nutrition education based on the Portfolio Diet that includes community gardening sessions. In addition, participants will take part in pre-implementation focus groups/interviews and post-implementation focus groups/interviews.
Read the detailed description
Peel has one of the highest rates of type 2 diabetes (T2D) in Ontario. Individuals with T2D have a higher risk of cardiovascular diseases (CVD), kidney disease, lower limb amputation and vision loss compared to the general population. Excess body weight, poor diet, and physical inactivity are key contributors to T2D risk, and are influenced by many factors including structural inequities and our built and food environments. Specific contributors in Peel include an urban design that discourages walking and a high proportion of residents with ethnic backgrounds at higher risk for T2D. There is an urgent need for local and practical T2D prevention strategies in Peel to ensure the health and quality of life of its residents. A healthy diet and lifestyle are important factors for preventing chronic diseases such as T2D.
The Portfolio Diet (PD) is an evidence-based healthy eating plan that has shown clinically meaningful reductions in T2D and CVD risk factors such as cholesterol and blood pressure in randomized controlled trials. Several prospective cohort studies have also shown the positive impact of the PD on the incidence of T2D and CVD. Given the strong scientific evidence, the PD is recommended by Diabetes Canada, the Canadian Cardiovascular Society and Obesity Canada.
An app for the PD (PortfolioDiet.app) was recently developed by the investigators. However, a strategy to deliver the PD at the community level has yet to be designed and evaluated. An intervention (program) that delivers tailored nutrition education based on the PD has the potential to be a successful strategy to address the T2D burden in Peel. This intervention (program) could help reduce barriers to accessing and understanding nutrition and health information, which are key elements of T2D prevention. A critical step to ensuring the success of such an intervention (program) is engaging with community stakeholders to design an effective implementation strategy.
The overarching aim of the proposed project is to assess the effectiveness of an intervention (program) that delivers nutrition education based on the PD on T2D risk factors. To achieve this, the investigators have partnered with the Peel Food Action Council (PFAC) and will conduct formative work using Consolidated Framework for Implementation Research (CFIR) to inform the implementation strategy for the intervention (program). The investigators also plan to incorporate community gardening sessions into the intervention led by PFAC to reinforce the nutrition education and enhance participant engagement. Community gardening programs have emerged as a strategy to improve diet quality especially when paired with nutrition education. The research questions pertain to understanding the barriers and facilitators for successful implementation of the intervention (program), evaluating its effectiveness on T2D risk factors and identifying implementation strategies for scaling up.
The specific aims are:
Aim 1: To conduct pre-implementation focus groups and interviews with the target population to inform the design of the intervention and implementation strategy.
Aim 1.2: To evaluate the effectiveness of the design of the curriculum and nutrition education modules teaching the Portfolio Diet through questionnaires and small group discussions with adults at risk of T2D (i.e. target population).
Aim 2: To assess the effect of the intervention among individuals at risk for T2D on changes in body weight, waist circumference, blood pressure and diet quality after 1 year compared to baseline.
Aim 2.1: To assess the effect of the intervention on biomarkers of T2D risk (glucose, insulin, lipids, HbA1c) after 1 year compared to baseline.
Aim 3: To conduct post-implementation focus groups and interviews with participants to determine the effectiveness of the intervention implementation and gather insights for scaling up.
- Conditions
- Type 2 Diabetes
- Being tested
- Nutrition Education and Community Gardening
- Keywords
- Peel, Portfolio Diet, Nutrition, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition Education and Community GardeningBehavioural
Participants will be presented with 16 nutrition education modules based on the Portfolio Diet, through group-based virtual sessions delivered by the investigators for one year. In addition, participants will take part in two community gardening sessions during growing season, and will grow Portfolio Diet foods such as eggplant, okra, and temperate climate fruit.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Twelve month lifestyle intervention comprised of nutrition education and community gardening based on the Portfolio Diet Receives: Behavioral: Nutrition Education and Community Gardening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in kilograms
Changes in body weight. Weight and height will be combined to report BMI in kg/m^2.
Measured: From baseline to 1 year after
Secondary outcomes (9)
Waist circumference in centimeters
Waist circumference will be measured in centimetres using measuring tape.
Measured: From baseline to 1 year after
Height in Centimetres
Height will be measured using a stadiometer. Height and weight will be combined to report BMI in kg/m^2
Measured: From baseline to 1 year after
Diet quality
Changes in diet quality will be assessed according to adherence to the Portfolio Diet, measured using the Harvard Food Frequency Questionnaire and 3-Day Diet Records using the Keenoa App. The Portfolio Diet score will be used to measure adherence with a score range between 6 and 30. A higher score indicates higher consumption of foods recommended in the diet.
Measured: From baseline to 1 year after
Insulin in pmol/L
Insulin will be measured through a lab test at LifeLabs. A blood sample will be drawn by a healthcare professional and analyzed.
Measured: From baseline to 1 year after
Glycated hemoglobin (HbA1c) as a percentage
Glycated hemoglobin (HbA1c) is a blood test that provides an average of blood sugar levels over the past 2-3 months. HbA1c will be measured through a lab test at LifeLabs. A blood sample will be drawn by a healthcare professional and analyzed.
Measured: From baseline to 1 year after
Blood pressure (systolic pressure and diastolic pressure)
Both systolic pressure and diastolic pressure will be assessed for changes 1 year after baseline. Blood pressure will be measured using an automatic blood pressure machine.
Measured: From baseline to 1 year after
Glucose Random in mmol/L
Glucose Random will be measured through a lab test at LifeLabs. A blood sample will be drawn by a healthcare professional and analyzed.
Measured: From baseline to 1 year after
Lipids (Cholesterol/HDL/LDL/Triglycerides) in mmol/L
Lipid Profile, is a blood test that measures different types of lipids in blood, including cholesterol (total, HDL, and LDL) and triglycerides. This test will be done at Life Labs where a blood sample will be drawn by a healthcare professional and analyzed.
Measured: From baseline to 1 year after
High-sensitivity C-reactive protein (hs-CRP) in mg/L
Hs-CRP is a marker of inflammation, and elevated levels can indicate increased cardiometabolic risk. A blood sample will be drawn by a healthcare professional at Life Labs and analyzed.
Measured: From baseline to 1 year after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One-group pretest-posttest design for implementation science involving: 1. Participation in a 12-month nutrition education intervention to prevent type 2 diabetes. 2. Assessing the effect of the intervention on changes in body weight (primary outcome), waist circumference, blood pressure and diet quality after 1 year from baseline using a one-group pretest-posttest design. 3. Assessing the effect of the intervention on biomarkers of T2D risk (glucose, insulin, lipids, HbA1c) after 1 year compared to baseline.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasanti Malik, University of Toronto
- Investigators
- Vasanti Malik, MSc, ScD, Principal investigator, University of Toronto, Department of Nutritional SciencesJohn Sievenpiper, MD, PhD, FRC, Study chair, University of Toronto, Department of Nutritional SciencesLaura Chiavaroli, MSc, PhD, Study chair, University of Toronto, Department of Nutritional Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058558
- Sponsor's protocol ID
- 46464
- Status last verified
- Aug 2025
- First submitted
- 6 Jun 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Knowledge, Reducing Risk: A Community- Integrated Nutrition Education Intervention to Prevent Type 2 Diabetes in Peel
- ClinicalTrials.gov ID
- NCT07058558
- Acronym / sponsor ID
- 46464
- Conditions
- Type 2 Diabetes
- Keywords
- Peel, Portfolio Diet, Nutrition, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Jul 2025 (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 goal of this clinical trial is to assess the effectiveness of an intervention that delivers nutrition education based on the Portfolio Diet on type-2 diabetes (T2D) risk factors among adults who are without chronic conditions, who have overweight and a high waist circumference plus one self-reported T2D risk factor. The main questions it aims to answer include:
- What are the barriers and facilitators for effective implementation of the nutrition education intervention?
- What is the effectiveness of the intervention on T2D risk factors?
- What are implementation strategies for scaling up the intervention?
Participants will participate in a 12-month lifestyle intervention comprised of nutrition education based on the Portfolio Diet that includes community gardening sessions. In addition, participants will take part in pre-implementation focus groups/interviews and post-implementation focus groups/interviews.
Detailed description
Peel has one of the highest rates of type 2 diabetes (T2D) in Ontario. Individuals with T2D have a higher risk of cardiovascular diseases (CVD), kidney disease, lower limb amputation and vision loss compared to the general population. Excess body weight, poor diet, and physical inactivity are key contributors to T2D risk, and are influenced by many factors including structural inequities and our built and food environments. Specific contributors in Peel include an urban design that discourages walking and a high proportion of residents with ethnic backgrounds at higher risk for T2D. There is an urgent need for local and practical T2D prevention strategies in Peel to ensure the health and quality of life of its residents. A healthy diet and lifestyle are important factors for preventing chronic diseases such as T2D.
The Portfolio Diet (PD) is an evidence-based healthy eating plan that has shown clinically meaningful reductions in T2D and CVD risk factors such as cholesterol and blood pressure in randomized controlled trials. Several prospective cohort studies have also shown the positive impact of the PD on the incidence of T2D and CVD. Given the strong scientific evidence, the PD is recommended by Diabetes Canada, the Canadian Cardiovascular Society and Obesity Canada.
An app for the PD (PortfolioDiet.app) was recently developed by the investigators. However, a strategy to deliver the PD at the community level has yet to be designed and evaluated. An intervention (program) that delivers tailored nutrition education based on the PD has the potential to be a successful strategy to address the T2D burden in Peel. This intervention (program) could help reduce barriers to accessing and understanding nutrition and health information, which are key elements of T2D prevention. A critical step to ensuring the success of such an intervention (program) is engaging with community stakeholders to design an effective implementation strategy.
The overarching aim of the proposed project is to assess the effectiveness of an intervention (program) that delivers nutrition education based on the PD on T2D risk factors. To achieve this, the investigators have partnered with the Peel Food Action Council (PFAC) and will conduct formative work using Consolidated Framework for Implementation Research (CFIR) to inform the implementation strategy for the intervention (program). The investigators also plan to incorporate community gardening sessions into the intervention led by PFAC to reinforce the nutrition education and enhance participant engagement. Community gardening programs have emerged as a strategy to improve diet quality especially when paired with nutrition education. The research questions pertain to understanding the barriers and facilitators for successful implementation of the intervention (program), evaluating its effectiveness on T2D risk factors and identifying implementation strategies for scaling up.
The specific aims are:
Aim 1: To conduct pre-implementation focus groups and interviews with the target population to inform the design of the intervention and implementation strategy.
Aim 1.2: To evaluate the effectiveness of the design of the curriculum and nutrition education modules teaching the Portfolio Diet through questionnaires and small group discussions with adults at risk of T2D (i.e. target population).
Aim 2: To assess the effect of the intervention among individuals at risk for T2D on changes in body weight, waist circumference, blood pressure and diet quality after 1 year compared to baseline.
Aim 2.1: To assess the effect of the intervention on biomarkers of T2D risk (glucose, insulin, lipids, HbA1c) after 1 year compared to baseline.
Aim 3: To conduct post-implementation focus groups and interviews with participants to determine the effectiveness of the intervention implementation and gather insights for scaling up.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One-group pretest-posttest design for implementation science involving: 1. Participation in a 12-month nutrition education intervention to prevent type 2 diabetes. 2. Assessing the effect of the intervention on changes in body weight (primary outcome), waist circumference, blood pressure and diet quality after 1 year from baseline using a one-group pretest-posttest design. 3. Assessing the effect of the intervention on biomarkers of T2D risk (glucose, insulin, lipids, HbA1c) after 1 year compared to baseline.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Nutrition Education and Community GardeningTwelve month lifestyle intervention comprised of nutrition education and community gardening based on the Portfolio Diet |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Must be in their 40s or older
- Must be a resident in the Peel region of the Greater Toronto Area
- Must not have any chronic conditions (that will impact participation in study)
- Must be overweight, have a high waist circumference plus one self-reported T2D risk factor (e.g. family history, non-white ethnicity, high blood pressure, high blood cholesterol, prediabetes)
- Must have a risk score of 21 or above using the CANrisk T2D screening tool (https://health.canada.ca/apps/canrisk-standalone/pdf/canrisk-en.pdf)
Key exclusion criteria (6 listed)
- Under the age of 40
- Not a resident in the Peel region of the Greater Toronto Area
- Has chronic conditions (that will impact participation in study)
- Not overweight, does not have a high waist circumference plus one self-reported T2D risk factor (e.g. family history, non-white ethnicity, high blood pressure, high blood cholesterol, prediabetes)
- Does not have a risk score of 21 or above using the CANrisk T2D screening tool (https://health.canada.ca/apps/canrisk-standalone/pdf/canrisk-en.pdf)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutrition Education and Community GardeningParticipants will be presented with 16 nutrition education modules based on the Portfolio Diet, through group-based virtual sessions delivered by the investigators for one year. In addition, participants will take part in two community gardening sessions during growing season, and will grow Portfolio Diet foods such as eggplant, okra, and temperate climate fruit. | Behavioural | Intervention |
Primary outcome
Weight in kilograms
Time frame: From baseline to 1 year after
Changes in body weight. Weight and height will be combined to report BMI in kg/m^2.
9 secondary outcomes
Waist circumference in centimeters
Time frame: From baseline to 1 year after
Height in Centimetres
Time frame: From baseline to 1 year after
Diet quality
Time frame: From baseline to 1 year after
Insulin in pmol/L
Time frame: From baseline to 1 year after
Glycated hemoglobin (HbA1c) as a percentage
Time frame: From baseline to 1 year after
Blood pressure (systolic pressure and diastolic pressure)
Time frame: From baseline to 1 year after
Glucose Random in mmol/L
Time frame: From baseline to 1 year after
Lipids (Cholesterol/HDL/LDL/Triglycerides) in mmol/L
Time frame: From baseline to 1 year after
High-sensitivity C-reactive protein (hs-CRP) in mg/L
Time frame: From baseline to 1 year after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- 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.
Vasanti Malik, MSc, ScD principal investigator
University of Toronto, Department of Nutritional Sciences
John Sievenpiper, MD, PhD, FRC study chair
University of Toronto, Department of Nutritional Sciences
Laura Chiavaroli, MSc, PhD study chair
University of Toronto, Department of Nutritional Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition Education and Community Gardening in people with Type 2 Diabetes, run by University of Toronto at 2 sites 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vasanti Malik, MSc, ScD (4169785556, vasanti.malik@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight in kilograms (time frame: From baseline to 1 year after). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2025.