What side effects are associated with this type of intervention?

The most common treatment for prediabetes involves lifestyle modifications, including diet and exercise, which generally have minimal side effects. However, individuals may experience initial muscle soreness, fatigue, or minor injuries from increased physical activity. Dietary changes can sometimes lead to gastrointestinal discomfort as the body adjusts to new eating patterns. For those on metformin, a common medication for prediabetes, side effects may include gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. It is important to consult with a healthcare provider to tailor the treatment plan and manage any side effects effectively.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs solely for the treatment of prediabetes. However, lifestyle modification programs focusing on diet and exercise, similar to the Small Steps for Big Changes (SSBC) program, are widely recommended and have been shown to be effective in managing prediabetes. These programs aim to reduce caloric intake, increase physical activity, and promote weight loss, which can significantly lower the risk of progressing to type 2 diabetes. While pharmacological treatments like metformin are sometimes used off-label for prediabetes, the primary approach remains lifestyle intervention.

What other types of research exist?

Promising novel alternatives for prediabetes patients in 2024 include the use of incretin mimetics and DPP-4 inhibitors. These new pharmacologic approaches aim to improve glycemic control and stabilize or reverse pancreatic islet-cell dysfunction. Additionally, emerging therapeutic strategies with fewer adverse effects, such as novel glucose-lowering drugs targeting the incretin system, are also being developed.

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Behavioral Intervention

Small Steps for Big Changes Program for Prediabetes (RFH Trial)

N/A

Waitlist Available

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults over the age of 18 and able to read and speak English

Be older than 18 years old

Must not have

Currently diagnosed with type 2 diabetes with an HbA1c of 6.5% or greater

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves lifestyle modifications rather than medications, typical drug side effects aren't expected; however participants may experience fatigue or muscle soreness due to new exercise routines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am over 18 and can read and speak English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have type 2 diabetes with an HbA1c of 6.5% or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 timepoints: (-3), 0-, 3-, 6-, 9-, 12-, 21-, and 24-months following diet and exercise intervention. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

change in hemoglobin A1c% (HbA1c%)

Secondary study objectives

change in caloric intake (kcal)

change in carbohydrate intake (grams)

change in fibre intake (grams)

+2 more

Other study objectives

eating motives

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: SSBC participantsExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prediabetes involve lifestyle modifications, particularly changes in diet and increased physical activity. These interventions work by improving insulin sensitivity and reducing blood glucose levels. A diet low in carbohydrates and high in fiber helps to stabilize blood sugar levels, while regular exercise enhances the body's ability to use insulin more effectively. These changes can lead to weight loss and a reduction in waist circumference, which are critical factors in managing prediabetes. For prediabetes patients, these modifications are essential as they can prevent the progression to type 2 diabetes and reduce the risk of associated complications such as cardiovascular disease.

How diabetic patients think about and manage their illness in Taiwan.