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Behavioral Nudges for Prediabetes (BEGIN Trial)

N/A

Waitlist Available

Led By Matthew J O'Brien, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Adult patients (aged 18-80 years) with prediabetes and overweight/obesity (BMI ≥25kg/m2)

Be older than 18 years old

Must not have

Type 2 diabetes

Current use of oral corticosteroids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Summary

This trial will test two low-touch interventions designed to motivate the adoption of treatments to prevent diabetes, which has the potential for large public health impact.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve behavioral nudges like text messages and decision aids rather than medications or invasive procedures, there are minimal expected side effects. The main focus is on encouraging lifestyle changes and treatment adoption.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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I have type 2 diabetes.

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I am currently taking oral corticosteroids.

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My blood pressure is not higher than 180/100 mmHg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Weight

Secondary study objectives

Metformin

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Text Messaging interventionExperimental Treatment1 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 interventionExperimental Treatment2 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 interventionExperimental Treatment1 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 CarePlacebo Group1 Intervention

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

0 / 4Eligibility criteria met