N/A
N=483
Presessions for the National Diabetes Prevention Program
Prediabetic State · Obesity · Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04022499 ↗Enrolled (actual)
483
Serious AEs
—
Results posted
Sep 2025
Primary outcome: Primary: Weight Loss — 3.1; 2.8 % of weight loss
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Presessions (Behavioral); National Diabetes Prevention Program (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Denver Health and Hospital Authority
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Weight Loss |
3.1; 2.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Denver Health patients
- BMI≥25 (≥23 if Asian)
- History of recent prediabetes or former gestational diabetes (GDM) diagnosis (patients without known prediabetes or past GDM may also be eligible based on a risk screening tool)
Exclusion Criteria
- Pregnant at enrollment
- Known to have diabetes
- Non-English or non-Spanish-speaking.
Data sourced from ClinicalTrials.gov (NCT04022499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.