Nutrition Education for Preventing Type 2 Diabetes

Not yet recruiting at 1 trial location

Overseen By Vasanti Malik, MSc, ScD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: Under 40, Not Peel resident, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special diet and nutrition education can reduce the risk of developing type 2 diabetes. Participants will learn about the Portfolio Diet, which emphasizes plant-based eating, through workshops and community gardening sessions. The trial targets individuals who are overweight, live in the Peel region, and have a high waist circumference, along with one other diabetes risk factor, such as high blood pressure or a family history of diabetes. Participants will engage in the program for 12 months and share their experiences in focus groups. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to healthier lifestyle changes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on nutrition education and lifestyle changes for those without chronic conditions.

What prior data suggests that this nutrition education intervention is safe?

Research has shown that the Portfolio Diet is safe for people. This plant-based diet can lower LDL cholesterol, often referred to as "bad" cholesterol, and reduce the risk of heart disease. It may also decrease the likelihood of developing type 2 diabetes, particularly in groups such as postmenopausal women.

Since this trial includes nutrition education based on the Portfolio Diet, it is expected to be well-tolerated. Studies have not identified any harmful effects from following this diet. Therefore, for those considering joining this trial, the diet and education component should be safe according to previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the community-integrated nutrition education approach for preventing type 2 diabetes because it combines nutrition education with hands-on community gardening based on the Portfolio Diet. Unlike standard treatments like medication or standard diet recommendations, this approach empowers individuals to learn about and grow their own healthy foods, which can lead to sustainable lifestyle changes. This method not only aims to improve dietary habits but also fosters a sense of community and support, which can be crucial for long-term adherence and success in preventing type 2 diabetes.

What evidence suggests that this nutrition education intervention is effective for preventing type 2 diabetes?

Research has shown that teaching people about nutrition in their communities can greatly lower the risk of developing type 2 diabetes. One study found that improving diet quality by just over 10% reduced diabetes risk by 16%. Another study discovered that educational programs could decrease the number of new diabetes cases by 54%, mainly by lowering blood sugar levels and body fat. These programs also enhance knowledge about nutrition, which is crucial for long-term health. This evidence supports the potential success of the community-integrated nutrition education program under study in this trial. ^{6 7 8 9 10}

Who Is on the Research Team?

Laura Chiavaroli, MSc, PhD

Principal Investigator

University of Toronto, Department of Nutritional Sciences

Vasanti Malik, MSc, ScD

Principal Investigator

University of Toronto, Department of Nutritional Sciences

John Sievenpiper, MD, PhD, FRC

Principal Investigator

University of Toronto, Department of Nutritional Sciences

Are You a Good Fit for This Trial?

This trial is for adults without chronic conditions but are overweight, have a high waist circumference, and at least one self-reported risk factor for type-2 diabetes. They should be interested in nutrition education and community gardening.

Inclusion Criteria

Must have a risk score of 21 or above using the CANrisk T2D screening tool

Must be a resident in the Peel region of the Greater Toronto Area

Must not have any chronic conditions that will impact participation in the study

Exclusion Criteria

Participating in another trial

Not a resident in the Peel region of the Greater Toronto Area

Has chronic conditions that will impact participation in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Conduct pre-implementation focus groups and interviews to inform the design of the intervention and implementation strategy

4 weeks

1-2 visits (in-person or virtual)

Treatment

Participants engage in a 12-month lifestyle intervention comprised of nutrition education and community gardening based on the Portfolio Diet

12 months

Monthly visits (in-person or virtual)

Post-implementation

Conduct post-implementation focus groups and interviews to determine the effectiveness of the intervention and gather insights for scaling up

4 weeks

1-2 visits (in-person or virtual)

Follow-up

Participants are monitored for changes in T2D risk factors such as body weight, waist circumference, blood pressure, and diet quality

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Community-integrated Nutrition Education

Trial Overview The study tests if nutrition education based on the Portfolio Diet combined with community gardening can reduce the risk factors of type-2 diabetes over a 12-month period. It includes pre- and post-intervention interviews to understand barriers and facilitators.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6650826/

The Impact of a Community-Based Food Education ... Our study revealed that a community-based food education program significantly increased nutrition-related knowledge in middle-aged and older ...

2. mdpi.com mdpi.com/2076-3417/14/5/2114

Effectiveness of a Nutrition Education Program for Patients ... In conclusion, this study adds to the existing scientific evidence of the benefits of a nutrition education program for patients with type 2 diabetes mellitus ...

3. jneb.org jneb.org/article/S1499-4046(23)00394-9/fulltext

Diet Quality Outcomes of a Cooperative Extension ... observed that with > 10% improvement in DQ, T2DM risk decreased by 16%. This association between DQ and T2DM risk was only partly (32%) ...

4. globalizationandhealth.biomedcentral.com globalizationandhealth.biomedcentral.com/articles/10.1186/s12992-019-0451-4

The effect of community-based programs on diabetes ... Community-based programs addressing diet, physical activity, and health behaviors have shown significant benefits on the prevention and management of T2DM.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7980624/

Community-based educational interventions for prevention of ... We conclude that educational interventions may reduce diabetes incidence by 54.0%, particularly through reductions in fasting blood glucose, body mass index, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07058558?aggFilters=status%3A%2Cphase%3A

Community-integrated Nutrition Education to Prevent Type ... A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07058558?locStr=Canada&country=Canada&rank=9

Community-integrated Nutrition Education to Prevent Type ... 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 ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9797645/

The Portfolio Diet and Incident Type 2 Diabetes Greater adherence to the Portfolio, DASH, and aMED diets was significantly associated with a lower risk of type 2 diabetes in postmenopausal women. These ...

9. mdpi.com mdpi.com/2072-6643/16/17/2817

The Portfolio Diet and HbA1c in Adults Living with Type 2 ... (5) Conclusions: Among adults living with T2DM, the Portfolio Diet was associated with lower HbA1c over a 6-month period, predominantly driven by two pillars: ...

10. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36162007/

The Portfolio Diet and Incident Type 2 Diabetes - PubMed - NIH Objective: A plant-based dietary pattern, the Portfolio Diet, has been shown to lower LDL cholesterol and other cardiovascular disease risk ...