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

NCT04869917 | Active Not Recruiting

• 1 other identifier: STU00212461
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

Brief 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

PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Weight

  Mean differences in weight (lbs) between treatment arms will be evaluated using mixed models adjusted for clinic site, time between visits, sex, age, race/ethnicity, and baseline cardiometabolic markers

  12 months

Secondary Outcomes (1)

• Participant initiation of treatment to intensive lifestyle (ILI) or Metformin

  12 months

Study Arms (4)

Decision Aid intervention

EXPERIMENTAL

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.

Behavioral: Decision Aid intervention

Text Messaging intervention

EXPERIMENTAL

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

Behavioral: Text Messaging intervention

Decision Aid intervention + Text Messaging intervention

EXPERIMENTAL

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.

Behavioral: Decision Aid intervention; Behavioral: Text Messaging intervention

Usual Care

PLACEBO COMPARATOR

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

Behavioral: Usual Care

Interventions

Decision Aid intervention 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

Decision Aid intervention; Decision Aid intervention + Text Messaging intervention

Text Messaging intervention 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; Text Messaging intervention

Usual Care BEHAVIORAL

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Vargas MC, Pineda GJ, Talamantes V, Toledo MJL, Owen A, Carcamo P, Gibbert W, Ackermann RT, Kandula NR, Cameron KA, Siddique J, Williams GC, O'Brien MJ. Design and rationale of behavioral nudges for diabetes prevention (BEGIN): A pragmatic, cluster randomized trial of text messaging and a decision aid intervention for primary care patients with prediabetes. Contemp Clin Trials. 2023 Jul;130:107216. doi: 10.1016/j.cct.2023.107216. Epub 2023 May 9.

  PMID: 37169219 DERIVED

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Matthew J O'Brien, MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 \[i.e. neither intervention\].

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 3, 2021
• Study Start: March 21, 2022
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 4, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)