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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Small Steps for Big Changes Program, which emphasizes diet and exercise, can help individuals with prediabetes make lasting health changes. Researchers seek to understand how dietary changes affect blood sugar levels, weight, and waist size over time. They also examine how motivations for eating might change and influence dietary choices. Individuals may be suitable candidates if they have been diagnosed with prediabetes or previously had type 2 diabetes but are currently managing without medication. As an unphased trial, this study offers a unique opportunity to contribute to understanding lifestyle changes for better health.

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 prior data suggests that the Small Steps for Big Changes Program is safe for individuals with prediabetes?

Research has shown that the Small Steps for Big Changes (SSBC) program is generally easy for participants to follow. In one study, trainers at fitness centers assisted people at risk for type 2 diabetes in changing their diet and exercise habits. The program targets individuals with prediabetes, where blood sugar levels are higher than normal but not yet classified as diabetes.

Another study tracked 92 people with prediabetes over three years. It found that more than three-quarters remained in the prediabetic range, and a small number returned to normal blood sugar levels. These results suggest that the program is safe and may help manage blood sugar levels. The studies did not specifically mention any side effects, indicating that serious negative effects were not a major concern. Overall, the program promotes healthy lifestyle changes in a supportive environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Small Steps for Big Changes (SSBC) Program for prediabetes because it emphasizes a personalized and structured lifestyle intervention over medication. Unlike standard treatments that often involve drugs like metformin, SSBC focuses on empowering participants to make sustainable diet and exercise changes. The program's unique feature is its six-week format, which provides intensive, hands-on guidance to help individuals form long-lasting healthy habits. This approach not only aims to prevent the progression to diabetes but also encourages self-efficacy, making it a potentially transformative option for lifestyle management.

What evidence suggests that the Small Steps for Big Changes Program is effective for prediabetes?

Research has shown that the Small Steps for Big Changes (SSBC) program, which participants in this trial will attend, can help lower the risk of developing Type 2 Diabetes. Studies have found that people who complete the program maintain weight loss and reduce waist size for at least six months. Participants also report feeling healthier and moving more easily. Many experience improvements in key health measures such as blood sugar (A1C), cholesterol, and body weight (BMI). These changes suggest that SSBC can provide lasting health benefits for those at risk of diabetes. ^{1 3 6 7 8}

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?

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+

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.

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]

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]

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 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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/292556/small-steps-for-big-changes-healthy-cities-implementation-science/

Small Steps for Big Changes - Healthy Cities ... Small Steps for Big Changes (SSBC) is a diet and exercise counselling program that significantly reduces the risk of developing Type 2 Diabetes ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499267120304147

An Evaluation of the Reach and Effectiveness of a ... Analyses of 6-month follow-up data revealed significant maintenance of reductions in weight and waist circumference and improvements in physical function, self- ...

3. smallstepsforbigchanges.com smallstepsforbigchanges.com/

Small Steps for Big Changes | Prediabetes Prevention Program Over the year I participated, my A1C, cholesterol, and BMI have returned to normal. They helped me create a healthy lifestyle within the context of my busy life ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10800278/

a cluster randomised controlled trial in Nepal Effectiveness of a group-based Diabetes Prevention Education Program (DiPEP) in a population with pre-diabetes: a cluster randomised controlled ...

5. anzctr.org.au anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624001194550

ANZCTR - Registration Small Steps for Big Changes is a diet and exercise coaching intervention targeting adults at risk of type 2 diabetes. It is delivered in the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03096002?tab=table

Small Steps for Big Changes: A Lifestyle Program to ... The purpose of this study is to address whether inactive individuals with prediabetes who take part in the Small Steps for Big Changes program, which is a 3- ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8541695/

Fitness facility staff demonstrate high fidelity when ... Small Steps for Big Changes is a brief diabetes prevention program for individuals aged 18+ who are at risk for developing T2D based on HbA1c of ...

8. withpower.com withpower.com/trial/phase-prediabetic-state-7-2023-2e8ec

Small Steps for Big Changes Program for Prediabetes · Info ... 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 ...