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

NCT07058558 | Not Yet Recruiting

• 1 other identifier: 46464
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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

Conditions

Type 2 Diabetes

Keywords

Peel; Portfolio Diet; Nutrition; Type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Weight in kilograms

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

  From baseline to 1 year after

Secondary Outcomes (9)

• Waist circumference in centimeters

  From baseline to 1 year after

• Height in Centimetres

  From baseline to 1 year after

• Diet quality

  From baseline to 1 year after

• Insulin in pmol/L

  From baseline to 1 year after

• Glycated hemoglobin (HbA1c) as a percentage

  From baseline to 1 year after

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: Nutrition Education and Community Gardening

Interventions

Nutrition Education and Community Gardening BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (2)

Community garden spaces across peel

Toronto, Ontario, Canada

Location

University of Toronto Mississauga

Mississauga, Ontario (ON), L5L 1C6, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Vasanti Malik, MSc, ScD

  University of Toronto, Department of Nutritional Sciences

  PRINCIPAL INVESTIGATOR

• John Sievenpiper, MD, PhD, FRC

  University of Toronto, Department of Nutritional Sciences

  STUDY CHAIR

• Laura Chiavaroli, MSc, PhD

  University of Toronto, Department of Nutritional Sciences

  STUDY CHAIR

Central Study Contacts

Vasanti Malik, MSc, ScD

CONTACT

4169785556; vasanti.malik@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2025
• First Posted: July 10, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)