Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care

Northwestern University

Status: Active, not recruiting

Conditions: PreDiabetes

Treatments: Behavioral: Usual Care; Behavioral: Text Messaging intervention; Behavioral: Decision Aid intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04869917

STU00212461

Details and patient eligibility

About

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.

Full description

Large randomized trials have found that intensive lifestyle interventions (ILI) and metformin are safe and effective treatment options for promoting modest weight loss and preventing type 2 diabetes (T2D) among adults with prediabetes. However, these treatments are rarely used in practice, and little existing research has focused on patient-centered approaches for promoting their use. One potential approach, behavioral nudges, involves manipulating health messages and treatment options to make behavior change more likely and easier to enact. While a large body of evidence suggests that behavioral nudges are effective, they have not been definitively studied for T2D prevention. The study team will address this critical knowledge gap by conducting the Behavioral Nudges for Diabetes Prevention (BEGIN) Trial. The proposed study will take place in primary care clinics, whose unprecedented reach and regular interaction with prediabetic adults make this an ideal setting for translational T2D prevention research. This definitive study will test two low-touch interventions: 1) prediabetes decision aid intervention consisting of a prediabetes decision aid designed to nudge uptake of evidence-based treatments and delivered by health educators; and 2) text messaging intervention consisting of text messages that deliver similar information and use the same behavioral nudges. The proposed R18 study will accomplish the following specific aims to determine the most effective low-touch intervention that promotes maximal treatment adoption and weight loss.

Enrollment: 960 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• adult patients (aged 18-80 years)
• with prediabetes
• overweight/obesity (BMI ≥25kg/m2)
• patients who speak English or Spanish

Exclusion criteria

• type 2 diabetes
• dementia
• serum creatinine >1.4mg/dL in women and >1.5mg/dL in men
• current use of oral corticosteroids
• current pregnancy
• uncontrolled hypertension (≥180/100mmHg)
• history of metformin use
• no office visits during the last 12 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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960 participants in 4 patient groups, including a placebo group

Decision Aid intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Decision Aid intervention

Text Messaging intervention

Experimental group

Description:

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

Treatment:

Behavioral: Text Messaging intervention

Decision Aid intervention + Text Messaging intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Decision Aid intervention

Behavioral: Text Messaging intervention

Usual Care

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Usual Care