JMIR Publications

ABSTRACT

Background:

Type 2 diabetes affects 9.4% of US adults with higher rates among racial/ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among diverse, underserved populations. Strategies to improve NDPP engagement and weight loss are needed urgently. Pilot results of the Pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a non-randomized cohort study among 1,140 racially diverse, predominately low-income participants. Seventy-five pre-session participants had doubled attendance and weight loss as compared to earlier participants who did not receive pre-sessions. Based on these promising results, we are conducting a randomized controlled trial (RCT) to determine whether Pre-NDPP reliably improves NDPP outcomes.

Objective:

The purpose of this study is to 1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive Pre-NDPP vs. direct enrollment into the NDPP (usual care), 2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race/ethnicity and income level), and 3) evaluate implementation factors, including cost and projected return on investment.

Methods:

This two-arm RCT will compare outcomes among diverse, predominately low-income participants who receive Pre-NDPP vs. direct enrollment into the NDPP (usual care). This is a type 1 hybrid effectiveness-implementation design to determine clinical effectiveness through an RCT, while assessing factors that may impact future Pre-NDPP dissemination and implementation, including cost. Our primary research question is whether Pre-NDPP improves NDPP attendance and weight loss compared to standard NDPP delivery.

Results:

This project was funded in April 2019. Recruitment is underway as of July 2019. Initial participants will begin the intervention in October 2019. Data analysis and results reporting is expected to be completed in 2024.

Conclusions:

This RCT of Pre-NDPP may lead to future dissemination of a scalable, evidence-based strategy to improve success of the NDPP, reduce disparities in NDPP effectiveness, and help prevent T2D across the country. Clinical Trial: ClinicalTrials.gov ID NCT04022499.