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

960 Participants Needed

Trial Summary

What is the purpose of this trial?

A large body of research has demonstrated that intensive lifestyle interventions and metformin are effective treatments to prevent or delay diabetes among high-risk adults, yet neither treatment is routinely used in practice. The Behavioral Nudges for Diabetes Prevention (BEGIN) Trial will test two low-touch interventions designed to motivate adoption of these treatments to prevent diabetes. Given that 38% of U.S. adults have prediabetes, the proposed study has potential for large public health impact by testing pragmatic, scalable, and sustainable approaches based in primary care to promote evidence-based treatment for this common condition.

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.

What data supports the effectiveness of the treatment Behavioral Nudges for Prediabetes?

Research shows that lifestyle interventions, like those in the English Diabetes Prevention Programme, can improve important health factors such as blood sugar levels and body weight in people with prediabetes. Additionally, technology-assisted goal setting has been shown to increase physical activity in prediabetes patients, which is a key component of managing the condition. ^{1 2 3 4 5}

Is the Behavioral Nudges for Prediabetes treatment safe for humans?

The research articles reviewed do not provide specific safety data for the Behavioral Nudges for Prediabetes treatment, but they do discuss the effectiveness of lifestyle interventions in improving health outcomes for prediabetes, which suggests these interventions are generally considered safe. ^{2 3 5 6 7}

How does usual care for prediabetes differ from other treatments?

Usual care for prediabetes typically involves standard medical advice and lifestyle recommendations without additional interventions like financial incentives or behavioral nudges, which are used in some other programs to improve adherence and outcomes. ^{1 2 7 8 9}

Research Team

Matthew J O'Brien, MD

Principal Investigator

Associate Professor

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Trial to Incentivise Adherence for Diabetes (TRIAD): study protocol for a randomised controlled trial. [2022]

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

The impact of financial incentives on utilization and outcomes of diabetes prevention programs among Medicaid managed care adults in New York state. [2021]

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

Awareness of Prediabetes Status and Subsequent Health Behavior, Body Weight, and Blood Glucose Levels. [2022]

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

A pilot randomized trial of technology-assisted goal setting to improve physical activity among primary care patients with prediabetes. [2023]

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

Quasi-experimental evaluation of a nationwide diabetes prevention programme. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics of participants in the Pre-Diabetes Interventions and Continued Tracking to Ease-out Diabetes (Pre-DICTED) Program. [2022]

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

The Diabetes Prevention Gap And Opportunities To Increase Participation In Effective Interventions. [2023]

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

Nudging to Change: Using Behavioral Economics Theory to Move People and Their Health Care Partners Toward Effective Type 2 Diabetes Prevention. [2023]

9. England pubmed.ncbi.nlm.nih.gov

A micro-randomized pilot study to examine the impact of just-in-time nudging on after-dinner snacking in adults with type 2 diabetes: A study protocol. [2023]