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N/A Completed N=483 Randomized Single-blind Prevention

Presessions for the National Diabetes Prevention Program

Prediabetic State · Obesity · Diabetes
Source: ClinicalTrials.gov NCT04022499 ↗
Enrolled (actual)
483
Serious AEs
Results posted
Sep 2025
Primary outcomePrimary: Weight Loss — 3.1; 2.8 % of weight loss

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Weight Loss
3.1; 2.8

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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