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Active, Not Recruiting

NCT Number: NCT04869917

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Usual Care

Behavioral

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

Primary outcomes

  1. Weight

    Time frame: 12 months

    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

Secondary outcomes

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

    Time frame: 12 months

    The number of participants that initiate ILI, Metformin, or both treatments at follow-up which will be assessed in the following ways. Because initiation of metformin requires a provider prescription, this will be assessed pragmatically using the electronic health record (EHR) and confirmed by participant self-report of taking at least 1 dose. Attendance logs will be used to confirm whether participants attended at least 1 ILI session. Those who received a prescription for metformin but do not take any doses will not be considered to have initiated treatment. Similarly, those who are referred to ILI but do not attend any sessions will not be classified as initiating treatment. Receiving a provider's prescription for metformin or referral for ILI without initiating treatment will be an exploratory outcome.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Acronym: BEGIN

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 3, 2021
Registry last updated
Nov 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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