NCT04869917: BEGIN

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

Active, enrolled NA Last updated 4 November 2025

What this trial tests

NA trial testing Decision Aid intervention in PreDiabetes in 960 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

21 March 2022

Primary endpoint
1 September 2025

1 September 2026

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	quadruple
Primary purpose	prevention
Enrollment	960
Start date	21 March 2022
Primary completion	1 September 2025
Estimated completion	1 September 2026
Sites	1 location across United States

Drugs / interventions tested

• Decision Aid intervention
• Text Messaging intervention
• Usual Care

Conditions studied

• PreDiabetes — all drugs for PreDiabetes →

Sponsor

Northwestern University

Who can join

Adults 18 to 80, any sex, with PreDiabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Decision aids for people facing health treatment or screening decisions.
   Stacey D, Lewis KB, Smith M, Carley M, et al · · 2024 · cited 203× · PMID 38284415 · DOI 10.1002/14651858.cd001431.pub6
2. 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.
   Vargas MC, Pineda GJ, Talamantes V, Toledo MJL, et al · · 2023 · cited 5× · PMID 37169219 · DOI 10.1016/j.cct.2023.107216
3. Covariate-constrained randomization in cluster randomized 2 × 2 factorial trials: application to a diabetes prevention study.
   Siddique J, Li Z, O'Brien MJ. · · 2024 · PMID 39243103 · DOI 10.1186/s13063-024-08415-z