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

PreDiabetes Clinical Trial

— BEGIN  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04869917
• Other study ID #: STU00212461
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 960
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Participant initiation of treatment to intensive lifestyle (ILI) or Metformin	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.	12 months