Small Steps for Big Changes Program for Prediabetes

(RFH Trial)

Overseen By Azize N Yildirim, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Disqualifiers: Type 2 diabetes, Pregnant, others

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

Compensation: Varies

Number of Visits: 12

250 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{3 6 7 8 9}

Eligibility Criteria

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.

I am over 18 and can read and speak English.

You have a high risk of developing type 2 diabetes based on a specific questionnaire score.

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

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)

Treatment Details

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.

Participant Groups

Group I: SSBC participants Experimental Treatment 1 Intervention

Participants will attend a 6-week diet and exercise changes program (SSBC).

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A systematic review of 11 trials found that lower-intensity lifestyle interventions for prediabetes showed limited effectiveness, with only one high-quality study demonstrating a 3-kg weight reduction and a 0.2% decrease in HbA1c over 6 months.

The overall evidence for these lower-intensity interventions is weak, highlighting the need for more robust research to explore their potential in diabetes prevention, especially given the low participation in traditional, high-intensity programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lower-Intensity Interventions for Prediabetes: A Systematic Review. Tseng, E., Lam, KY., Meza, KA., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

The Prediabetes Outcome at National Guard Primary Health Care Centers in Riyadh, Saudi Arabia: Retrospective Chart Review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Diabetes Self-Management: Facilitating Lifestyle Change. [2017]

3. Canada pubmed.ncbi.nlm.nih.gov

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]

4. Ireland pubmed.ncbi.nlm.nih.gov

Factors associated with progression of different prediabetic status to Diabetes: A Community-based cohort study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Impact of telephone support programme using telemonitoring on stage of change towards healthy eating and active exercise in people with prediabetes. [2022]

6. Canada pubmed.ncbi.nlm.nih.gov

"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]

7. England pubmed.ncbi.nlm.nih.gov

The Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) program: study protocol for a randomized controlled trial. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Lower-Intensity Interventions for Prediabetes: A Systematic Review. [2023]