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Not yet recruitingNCT07058558Updated Aug 5, 2025

Community-integrated Nutrition Education to Prevent Type 2 Diabetes in Peel

An interventional study of Nutrition Education and Community Gardening in Type 2 Diabetes, sponsored by University of Toronto. Not yet recruiting at 2 sites in Canada. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-05.

Sponsored by University of Toronto · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study 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 factor. The main questions it aims to answer include:

  1. What are the barriers and facilitators for effective implementation of the nutrition education intervention?
  2. What is the effectiveness of the intervention on T2D risk factors?
  3. 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • Peel
  • Portfolio Diet
  • Nutrition
  • Type 2 diabetes
03

In context

Diabetes Mellitus, Type 2

9,357 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 7,523 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Toronto is the lead sponsor of 397 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Intervention

    Twelve month lifestyle intervention comprised of nutrition education and community gardening based on the Portfolio Diet

    Behavioral: Nutrition Education and Community Gardening

Interventions

  • BehavioralNutrition Education and Community Gardening

    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.

06

What researchers measure

Primary outcomes

  1. Weight in kilograms

    Changes in body weight. Weight and height will be combined to report BMI in kg/m\^2.

    Time frame: From baseline to 1 year after

Secondary outcomes

  1. Waist circumference in centimeters

    Waist circumference will be measured in centimetres using measuring tape.

    Time frame: From baseline to 1 year after

  2. Height in Centimetres

    Height will be measured using a stadiometer. Height and weight will be combined to report BMI in kg/m\^2

    Time frame: From baseline to 1 year after

  3. 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.

    Time frame: From baseline to 1 year after

  4. 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.

    Time frame: From baseline to 1 year after

  5. 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.

    Time frame: From baseline to 1 year after

  6. 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.

    Time frame: From baseline to 1 year after

  7. 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.

    Time frame: From baseline to 1 year after

  8. 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.

    Time frame: From baseline to 1 year after

  9. 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.

    Time frame: From baseline to 1 year after

07

Study locations

2 sites
  • Community garden spaces across peel
    Toronto, Ontario, Canada
  • University of Toronto Mississauga
    Mississauga, Ontario (ON) L5L 1C6, Canada
08

References and documents

Study documents

  • Informed consent form · May 8, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07058558
Lead sponsor
University of Toronto
Responsible party
Vasanti Malik (Assistant Professor, University of Toronto) — Principal investigator
First posted
Jul 10, 2025
Start date
Sep 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Feb 2027 (estimated)
Last update
Aug 5, 2025

Study contacts

Vasanti Malik, MSc, ScD
Contact
vasanti.malik@utoronto.ca
4169785556
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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