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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

960 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This study will utilize a 2x2 factorial design to test the effectiveness of the two proposed interventions on outcomes. Each of the participating clinical sites will be randomized to one of 4 treatment conditions. Employing a full factorial design, the participating clinics sites will be randomized to 1 of the following 4 treatment conditions: a) prediabetes decision aid intervention alone; b) text messaging intervention alone; c) both interventions; and d) usual care \[i.e. neither intervention\].

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Decision Aid 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 Type EXPERIMENTAL

Decision Aid intervention

Intervention Type BEHAVIORAL

* Displays information about the benefits and risks of ILI and metformin
* Asks open-ended questions: "What am I willing to do to prevent T2D?" and "What do I need to prevent T2D?"
* Prompts patients to commit to immediate next steps
* Health educator schedules interested patients for first ILI session or sends message to provider about patients' interest in starting metformin, if chosen

Text Messaging intervention

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

Group Type EXPERIMENTAL

Text Messaging intervention

Intervention Type BEHAVIORAL

* Defines prediabetes and includes individualized A1c values
* Present benefits and risks of intensive lifestyle intervention and metformin
* States that other prediabetic Erie patients are adopting intensive lifestyle intervention and metformin
* Encourages initiating intensive lifestyle intervention or discussing metformin with provider
* Include selected behavioral content from diabetes prevention program
* Initial message with automatic opt-in, allows opt-out for messages
* Subsequent messages include: information about T2D risk and treatments; prompts to directly schedule intensive lifestyle intervention or office visit to discuss metformin; selected behavioral content from diabetes prevention programming

Decision Aid intervention + Text Messaging intervention

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 Type EXPERIMENTAL

Decision Aid intervention

Intervention Type BEHAVIORAL

* Displays information about the benefits and risks of ILI and metformin
* Asks open-ended questions: "What am I willing to do to prevent T2D?" and "What do I need to prevent T2D?"
* Prompts patients to commit to immediate next steps
* Health educator schedules interested patients for first ILI session or sends message to provider about patients' interest in starting metformin, if chosen

Text Messaging intervention

Intervention Type BEHAVIORAL

* Defines prediabetes and includes individualized A1c values
* Present benefits and risks of intensive lifestyle intervention and metformin
* States that other prediabetic Erie patients are adopting intensive lifestyle intervention and metformin
* Encourages initiating intensive lifestyle intervention or discussing metformin with provider
* Include selected behavioral content from diabetes prevention program
* Initial message with automatic opt-in, allows opt-out for messages
* Subsequent messages include: information about T2D risk and treatments; prompts to directly schedule intensive lifestyle intervention or office visit to discuss metformin; selected behavioral content from diabetes prevention programming

Usual Care

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

Group Type PLACEBO_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Patients receiving care at non-intervention clinic sites will not be exposed to treatment intervention.

Interventions

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Decision Aid intervention

* Displays information about the benefits and risks of ILI and metformin
* Asks open-ended questions: "What am I willing to do to prevent T2D?" and "What do I need to prevent T2D?"
* Prompts patients to commit to immediate next steps
* Health educator schedules interested patients for first ILI session or sends message to provider about patients' interest in starting metformin, if chosen

Intervention Type BEHAVIORAL

Text Messaging intervention

* Defines prediabetes and includes individualized A1c values
* Present benefits and risks of intensive lifestyle intervention and metformin
* States that other prediabetic Erie patients are adopting intensive lifestyle intervention and metformin
* Encourages initiating intensive lifestyle intervention or discussing metformin with provider
* Include selected behavioral content from diabetes prevention program
* Initial message with automatic opt-in, allows opt-out for messages
* Subsequent messages include: information about T2D risk and treatments; prompts to directly schedule intensive lifestyle intervention or office visit to discuss metformin; selected behavioral content from diabetes prevention programming

Intervention Type BEHAVIORAL

Usual Care

Patients receiving care at non-intervention clinic sites will not be exposed to treatment intervention.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes