4400 Participants Needed

Diabetes Prevention Program for Prediabetes

(HCIS Trial)

Recruiting at 13 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of British Columbia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to expand a diet and exercise program designed to lower the risk of developing Type 2 Diabetes. The researchers focus on implementing the program across various YMCA locations in Canada and assessing its effectiveness in improving health outcomes, such as blood sugar levels and weight. Participants will engage in a 4-week program that promotes regular exercise and simple dietary changes, with follow-ups for two years. Individuals diagnosed with prediabetes or in remission from Type 2 Diabetes (without medication for at least three months) may be suitable for the trial. As a Phase 2 trial, this research measures the program's effectiveness in an initial, smaller group, allowing participants to contribute to significant health advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on diet and exercise changes to prevent diabetes.

What prior data suggests that this program is safe for participants?

Research has shown that the Diabetes Prevention Program (DPP), which includes diet and exercise, is safe for people to follow. Studies have found that regular physical activity, such as brisk walking for 150 minutes a week, is beneficial and does not cause serious side effects. These lifestyle changes help lower the risk of developing Type 2 Diabetes by focusing on weight loss and a healthier diet.

The DPP has undergone thorough review, and findings suggest it is well-tolerated by participants. The program encourages healthy habits, aiming for at least a 7% weight loss through simple changes in daily routines. Overall, it focuses on making lasting lifestyle adjustments rather than relying on medication.

While individual experiences may vary, evidence supports the safety and effectiveness of this program for most people. Participants generally report positive health improvements without significant negative effects.12345

Why are researchers excited about this trial?

Researchers are excited about the "Small Steps for Big Changes: Diabetes Prevention Program" because it focuses on making sustainable lifestyle changes rather than relying on medication. Unlike standard treatments for diabetes prevention, which often include medications like Metformin, this program emphasizes a holistic approach. It combines regular exercise with simple dietary strategies, empowering participants to take control of their health. This approach is unique because it aims for long-term behavior change, potentially leading to lasting health benefits without the side effects associated with medication. Additionally, the program's structure over a concise four-week period, followed by extended support, could provide a more accessible and engaging way for people to prevent diabetes effectively.

What evidence suggests that the Small Steps for Big Changes program is effective for preventing Type 2 Diabetes?

Research has shown that the Diabetes Prevention Program (DPP), which participants in this trial will undertake, can greatly reduce the risk of developing type 2 diabetes. One study found that people in the DPP Lifestyle Change Program lowered their chances of getting type 2 diabetes by 58%. Additionally, 36% of participants lost at least 5% of their body weight, and 42% reported engaging in at least 150 minutes of physical activity each week. The program also improved their diet, increased their physical activity, and provided other health benefits. Overall, the DPP has strong evidence of effectiveness in preventing type 2 diabetes through lifestyle changes.16789

Are You a Good Fit for This Trial?

Inclusion Criteria

Patients
I have been diagnosed with prediabetes or have HbA1c levels between 5.7 - 6.4%.
My type 2 diabetes is in remission with an A1C below 6.4% without medication for over 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 4-week diabetes prevention program consisting of diet and exercise counseling sessions

4 weeks
6 sessions (in-person)

Follow-up

Participants are monitored for changes in health outcomes such as T2D status, blood glucose, and weight over 2 years

24 months

Sustainability Phase

Focus on the sustainability of the program delivery and continued monitoring of implementation outcomes

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Small Steps for Big Changes Diabetes Prevention Program

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Small Steps for Big Changes: Diabetes Prevention ProgramExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials
1,506
Recruited
2,528,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Public Health Agency of Canada (PHAC)

Collaborator

Trials
51
Recruited
101,000+

McMaster University

Collaborator

Trials
936
Recruited
2,630,000+

Memorial University of Newfoundland

Collaborator

Trials
73
Recruited
1,836,000+

Brock University

Collaborator

Trials
41
Recruited
6,500+

Arthritis Research Centre of Canada

Collaborator

Trials
16
Recruited
12,200+

Citations

Diabetes Prevention Program (DPP) - NIDDK

After about 3 years, the DPP showed that participants in the DPP Lifestyle Change Program lowered their chances of developing type 2 diabetes by 58 percent ...

NIDDK's Journey Into the Prevention of Type 2 Diabetes and ...

The main results indicate a diabetes reduction versus placebo of 58 percent with intensive lifestyle intervention and 31 percent with metformin ...

Uptake, retention, and outcomes of the National Diabetes ...

Between 2012 and 2016, 36% of enrollees achieved 5% weight loss and 42% reported at least 150 min of physical activity per week [4]. CDC-recognized lifestyle ...

What Is the National DPP? | National Diabetes Prevention ...

Results from the study showed that this structured lifestyle change program—in which participants achieved weight loss of 5 to 7 percent of ...

Evidence

In addition to weight loss, participants reported improved nutrition, increased physical activity, and improved health-related outcomes such as reductions in ...

3. Prevention or Delay of Diabetes and Associated ...

Moderate-intensity physical activity, such as brisk walking for 150 min/week, has shown beneficial effects in those with prediabetes (5).

Public Health Research and Program Strategies for ...

Research has identified effective, scalable interventions to address modifiable risk factors such as poor diet, obesity, and physical inactivity.

A systematic review of diabetes prevention programs ...

This review examined the state of the science regarding interventions that adapted the Diabetes Prevention Program (DPP) lifestyle change curriculum to include ...

The Diabetes Prevention Program (DPP) - PubMed Central

The two major goals of the Diabetes Prevention Program (DPP) lifestyle intervention were a minimum of 7% weight loss/weight maintenance and a minimum of 150 min ...