Behavioral Nudges for Prediabetes

(BEGIN Trial)

Overseen By Matthew J O'Brien, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Must not be taking: Oral corticosteroids

Disqualifiers: Type 2 diabetes, Dementia, Pregnancy, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new methods to help people with prediabetes make lifestyle changes or consider using metformin to prevent diabetes. It focuses on simple interventions, such as decision aids and text messages, to encourage these treatments. Participants will be divided into groups: some will receive both information and text messages, some only one of these, and others will continue with their standard care. It is ideal for adults who are overweight, have prediabetes, and speak either English or Spanish. As an unphased trial, this study provides a unique opportunity to explore innovative approaches to managing prediabetes.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are currently using oral corticosteroids, you would not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Decision Aid intervention is safe. Studies indicate it reduces uncertainty and helps people make more confident health choices. Participants reported feeling better about their decisions and were more likely to choose beneficial treatment options.

The Text Messaging intervention also shows positive results. Participants in past studies reported feeling less stressed and better supported. They felt more informed and confident in managing their health. Text messages helped improve their blood sugar control, which is crucial for preventing diabetes.

Using both interventions together has improved health outcomes. These methods provide useful information about diabetes risk and treatment options.

Overall, both interventions have been well-received and have not shown any major safety concerns. They are designed to help people make better health decisions without added risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative ways to combat prediabetes through behavioral nudges. Unlike standard treatments that often focus solely on medication like metformin or lifestyle changes, this trial tests the power of decision aids and text messaging interventions. The decision aid intervention provides personalized information on the benefits and risks of lifestyle changes and medication, aiming to empower patients. Meanwhile, the text messaging intervention delivers biweekly motivational messages, keeping participants engaged and proactive about their health. By combining these approaches, researchers hope to find more effective ways to support lifestyle changes and prevent the progression to diabetes.

What evidence suggests that this trial's interventions could be effective for prediabetes?

Research has shown that tools called decision aids help people make informed choices about preventing diabetes. In this trial, some participants will receive a prediabetes decision aid. Studies have found that this aid leads to a better understanding of the condition, less confusion, and a higher likelihood of starting treatments like lifestyle changes or taking metformin. Other participants will receive text messaging interventions, which previous studies have linked to lower chances of developing diabetes and better blood sugar control. Additionally, one arm of this trial will combine decision aids and text messaging, potentially increasing these benefits and encouraging more people to take steps to prevent diabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Matthew J O'Brien, MD

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

The BEGIN Trial is for English or Spanish-speaking adults aged 18-80 with prediabetes and overweight (BMI ≥25kg/m2). It's not for those with type 2 diabetes, dementia, current steroid use, pregnancy, no recent doctor visits, kidney issues indicated by high serum creatinine levels, past metformin use or very high blood pressure.

Inclusion Criteria

I am 18-80 years old, overweight or obese, and have prediabetes.

Exclusion Criteria

You have dementia.

Your blood test shows that the level of creatinine is too high.

I have taken metformin before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive behavioral nudges through decision aids and/or text messaging interventions to promote diabetes prevention over 12 months

12 months

Biweekly messages, brief meetings with health educators after each office visit

Follow-up

Participants are monitored for weight changes and treatment initiation of intensive lifestyle intervention or Metformin

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Automated intervention
• Decision Aid intervention
• In-person intervention
• Text Messaging intervention
• Usual Care

Trial Overview

This trial tests two 'nudge' strategies to prevent diabetes in primary care: a text messaging intervention and a decision aid tool. Participants will either receive these interventions or continue with usual care without additional support.

How Is the Trial Designed?

Group I: Text Messaging intervention Experimental Treatment 1 Intervention

Participants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform.

Group II: Decision Aid intervention + Text Messaging intervention Experimental Treatment 2 Interventions

Health Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid. Additionally, participants will receive biweekly messages throughout the 12-month trial. Automated messages will be sent using an existing secure text messaging platform.

Group III: Decision Aid intervention Experimental Treatment 1 Intervention

Health Educators (HEs) will meet briefly with eligible participants after each office visit to review a prediabetes decision aid which reviews information about the benefits and risks of intensive lifestyle intervention and metformin.

Group IV: Usual Care Placebo Group 1 Intervention

Usual care includes no additional intervention above the care routinely provided at the clinical partner site, Erie Family Health Center.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

The ADAPT program significantly increased daily physical activity among patients with prediabetes, with participants in the intervention group walking an average of 1418 more steps per day compared to a decrease of 598 steps in the control group over 6 months.

While there was a trend towards weight loss in the intervention group (-1.0 lbs) compared to the control group (-3.0 lbs), there was no significant change in glycemic control, indicating that while physical activity improved, further strategies may be needed to impact weight and blood sugar levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of technology-assisted goal setting to improve physical activity among primary care patients with prediabetes. Mann, DM., Palmisano, J., Lin, JJ.[2023]

Notifying individuals of their prediabetes status led to significant improvements in fasting plasma glucose and weight loss over 18 months, suggesting that awareness can motivate lifestyle changes.

Participants with prediabetes reported better dietary and exercise habits compared to a control group, indicating that self-directed lifestyle modifications may be a key factor in improving glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness of Prediabetes Status and Subsequent Health Behavior, Body Weight, and Blood Glucose Levels. Owei, I., Umekwe, N., Ceesay, F., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10330561/

Design and Rationale of Behavioral Nudges for Diabetes ...

Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714423001398

Design and rationale of behavioral nudges for diabetes ...

Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11618152/

Advancing Type 2 Diabetes Prevention through Text ...

The text-messages' group had a lower diabetes conversion rate (22.2%) compared to the control group (28%) but a higher conversion than the in- ...

4.

jmir.org

jmir.org/2025/1/e70981

A Multifaceted Digital Intervention for the Prevention of ...

Objective: This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of ...

5.

sciencedirect.com

sciencedirect.com/org/science/article/pii/S1438887125013524

A Multifaceted Digital Intervention for the Prevention of ...

This study aimed to evaluate the effectiveness of PREDIABETEXT (Prediabetes Text Message Digital Intervention for the Prevention of Type 2 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37169219/

Design and rationale of behavioral nudges for diabetes ...

Text messaging and decision aids displaying disease risk and treatment information have improved outcomes in prior research. However, these approaches have not ...

7.

sciencedirect.com

sciencedirect.com/science/article/am/pii/S1551714423001398

Design and Rationale of Behavioral Nudges for Diabetes ...

Prediabetes health risk information is provided at the top of the decision aid before presentation of treatment options. Initial text messages present ...

8.

diabetes.jmir.org

diabetes.jmir.org/2024/1/e55473/

Impact of a Text Messaging Intervention as an In-Between ...

Our study showed improved diabetes distress, social support, knowledge, self-care, self-efficacy, and quality of life among patients highly engaged in the SMS ...

9.

link.springer.com

link.springer.com/article/10.1007/s11892-024-01568-w

Advancing Type 2 Diabetes Prevention through Text ...

This scoping review evaluates recent literature on text-messaging interventions focused on diabetes prevention, highlighting their development, associated ...