Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Northwestern University
- Enrollment
- 960
- Locations
- 1
- Primary Endpoint
- Weight
Study Overview
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
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.
Intervention: Decision Aid intervention (Behavioral)
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.
Intervention: Text Messaging intervention (Behavioral)
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.
Intervention: Decision Aid intervention (Behavioral)
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.
Intervention: Text Messaging intervention (Behavioral)
Usual Care
Usual care includes no additional intervention above the care routinely provided at the clinical partner site, Erie Family Health Center.
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
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
- Participant initiation of treatment to intensive lifestyle (ILI) or Metformin(12 months)
Investigators
Matthew J O'Brien
Associate Professor
Northwestern University