CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 483 enrolled
Drug / intervention
Presessions +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04022499
NCT04022499N/ACompleted

Enhanced Enrollment in the National Diabetes Prevention Program for the Underserved: a Randomized Control Trial

Denver Health and Hospital Authority·interventional·Posted Jul 17, 2019·Updated Sep 5, 2025

In Brief

A clinical study evaluating Presessions and National Diabetes Prevention Program for Prediabetic State and 2 related conditions. Completed, enrolled 483 participants across 1 site.

Detailed Summary

The National Diabetes Prevention Program (NDPP) is a widely available, evidence-based intervention that promotes weight loss to prevent type 2 diabetes; however, participant attendance is problematic and leads to suboptimal weight loss, especially among Hispanic, non-Hispanic black, and low-income non-Hispanic white participants. An innovative pre-session enhancement to the NDPP (Pre-NDPP) showed successful results upon initial application in a diverse and predominately low-income population, with doubled attendance and weight loss outcomes as compared to previous NDPP participants who did not receive a pre-session. If Pre-NDPP is shown to be successful upon more rigorous study, it can be widely adopted by NDPP providers across the country to help reduce diabetes prevalence and related health disparities.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 17, 2019
Enrollment StartAug 6, 2019
Primary CompletionApr 29, 2024
Study CompletionAug 1, 2024
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 7.0 years ago

Interventions

Presessionsbehavioral

The Pre-NDPP arm includes a "pre-session" with three components: 1) education about diabetes risks, 2) motivational interviewing (MI) to encourage participation in the NDPP and, 3) problem-solving of barriers to engagement.

National Diabetes Prevention Programbehavioral

The Diabetes Prevention Program was a successful clinical trial demonstrating that intensive lifestyle support for weight loss reduced diabetes incidence by 58%. The intervention was translated into the National Diabetes Prevention Program (NDPP) and disseminated by the Centers for Disease Control and Prevention as a yearlong group-based program since 2012.