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

NCT04869917 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 960

Last updated 2025-11-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

BEHAVIORAL

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

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

BEHAVIORAL

Usual Care

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

Sponsors & Collaborators

Principal Investigators

  • Matthew J O'Brien, MD · Associate Professor

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-21
Primary Completion
2025-09-01
Completion
2026-09-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869917 on ClinicalTrials.gov