250 Participants Needed

Small Steps for Big Changes Program for Prediabetes

(RFH Trial)

ME
AN
Overseen ByAzize N Yildirim, MSc
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 evaluates the effectiveness of the 'Small Steps for Big Changes' (SSBC) program, designed to help people with prediabetes improve their diet and exercise habits. The goal is to see if these changes can lower blood sugar levels, reduce weight, and decrease waist size over time. Participants receive personalized guidance and support from trainers at YMCA locations. The 'Small Steps for Big Changes' (SSBC) program emphasizes behavior change techniques and motivational interviewing to help adults at risk for type 2 diabetes.

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 is best to consult with the trial coordinators for specific guidance.

How does the Small Steps for Big Changes treatment differ from other treatments for prediabetes?

The Small Steps for Big Changes program is unique because it focuses on promoting long-term physical activity and dietary changes through motivational interviewing, a counseling approach that helps individuals find their own motivation to change. Unlike other programs that may require long-term commitments, this is a short, 3-week intervention designed to be scalable and community-based, making it more accessible and potentially more sustainable for individuals at risk of developing type 2 diabetes.12345

What data supports the effectiveness of the Small Steps for Big Changes Program treatment for prediabetes?

The Small Steps for Big Changes Program is an evidence-based diabetes prevention program that helps improve diet and exercise habits in people at risk for type 2 diabetes. Research shows that healthy eating and increased physical activity can prevent or delay diabetes, and the program focuses on these lifestyle changes to reduce diabetes risk.36789

Are You a Good Fit for This Trial?

This trial is for adults over 18 at high risk of type 2 diabetes or living with prediabetes, having HbA1c levels between 5.7-6.4%. It's also open to those in remission from type 2 diabetes with HbA1c below 6.4% without medication for at least three months. Pregnant individuals and current type 2 diabetics with an HbA1c of 6.5% or higher are excluded.

Inclusion Criteria

My type 2 diabetes is in remission with an HbA1c below 6.4% without medication for over 3 months.
You have a high risk of developing type 2 diabetes based on a specific questionnaire score.
My HbA1c levels are between 5.7% and 6.4%, indicating prediabetes.

Exclusion Criteria

Failure to obtain participant's signed declaration for the Get Active questionnaire
Pregnant
I have type 2 diabetes with an HbA1c of 6.5% or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diet and Exercise Intervention

Participants attend a 6-week diet and exercise changes program (SSBC) at YMCA locations, receiving diet and exercise counseling aimed at setting personalized goals and improving self-monitoring skills.

6 weeks
6 visits (in-person)

Short-term Follow-up

Participants are monitored for changes in HbA1c levels, diet, weight, and waist circumference at 3 and 6 months post-intervention.

6 months
2 visits (in-person)

Medium-term Follow-up

Participants continue to be monitored for changes in dietary intake and anthropometrics at 9 and 12 months post-intervention.

6 months
2 visits (in-person)

Long-term Follow-up

Participants are monitored for long-term changes in HbA1c levels, weight, and waist circumference at 21 and 24 months post-intervention.

12 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Small Steps for Big Changes Program
Trial Overview The 'Small Steps for Big Changes' program focuses on diet and exercise changes over six weeks to see if it improves blood sugar control (HbA1c), weight, waist size, eating habits, and motives behind food choices in the short to long term after completing the program.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: SSBC participantsExperimental 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+

Published Research Related to This Trial

In a study of 92 prediabetic patients followed for three years, 76.08% remained in the prediabetic range, while only 16.4% reverted to normal blood sugar levels, indicating that many patients did not improve significantly despite interventions.
The use of metformin, a common medication for managing blood sugar, did not show a significant benefit in helping patients regress to a normal glycemic state, suggesting that more research is needed to explore effective interventions for prediabetes.
The Prediabetes Outcome at National Guard Primary Health Care Centers in Riyadh, Saudi Arabia: Retrospective Chart Review.Alateeq, MA., Aljohani, M., Kinani, SS., et al.[2020]
Healthy eating and increased physical activity are crucial for preventing and managing diabetes, with guidelines recommending a 5% to 7% weight loss and 150 minutes of moderate-intensity exercise weekly for those with prediabetes and diabetes.
Effective diabetes management involves personalized lifestyle changes, where physicians should assess patients' readiness for change, set specific short-term goals, and provide ongoing support to enhance adherence and confidence in their health journey.
Diabetes Self-Management: Facilitating Lifestyle Change.Koenigsberg, MR., Corliss, J.[2017]
A telephone support program significantly improved participants' progression to healthier eating habits in adults with prediabetes, with an odds ratio of 1.31 compared to a control group after one year.
The program also led to decreased fasting plasma glucose levels specifically in participants who were in the contemplation stage of change, indicating targeted benefits for those considering lifestyle changes.
Impact of telephone support programme using telemonitoring on stage of change towards healthy eating and active exercise in people with prediabetes.Sakane, N., Oshima, Y., Kotani, K., et al.[2022]

Citations

The Prediabetes Outcome at National Guard Primary Health Care Centers in Riyadh, Saudi Arabia: Retrospective Chart Review. [2020]
Diabetes Self-Management: Facilitating Lifestyle Change. [2017]
Identifying Behaviour Change Techniques and Motivational Interviewing Techniques in Small Steps for Big Changes: A Community-Based Program for Adults at Risk for Type 2 Diabetes. [2021]
Factors associated with progression of different prediabetic status to Diabetes: A Community-based cohort study. [2022]
Impact of telephone support programme using telemonitoring on stage of change towards healthy eating and active exercise in people with prediabetes. [2022]
"It's a Life Thing, Not a Few Months Thing": Profiling Patterns of the Physical Activity Change Process and Associated Strategies of Women With Prediabetes Over 1 Year. [2021]
The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) program: study protocol for a randomized controlled trial. [2021]
Effects of self-care programs on the incidence of diabetes among adults with prediabetes: A systematic review and meta-analysis of randomised controlled trials. [2023]
Lower-Intensity Interventions for Prediabetes: A Systematic Review. [2023]
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