Clinical trial NCT04869917: Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care
Official title: Behavioral Nudges for Diabetes Prevention (BEGIN) Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PreDiabetes
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 \[i.e. neither intervention\].
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight
timeFrame: 12 months
Secondary outcomes:
measure: Participant initiation of treatment to intensive lifestyle (ILI) or Metformin
timeFrame: 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Associate Professor
name: Matthew J O'Brien, MD
role: PRINCIPAL_INVESTIGATOR
References: