Presessions for the National Diabetes Prevention Program

Part of paid clinical trials in Denver, Colorado.

Sponsor
Denver Health and Hospital Authority
Study ID
NCT04022499
Status
Completed

Conditions

  • Gestational Diabetes
  • Obesity
  • Prediabetic State

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Presessions — BEHAVIORAL
    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 Program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 6, 2019
Status verified
May 2025
Primary completion
Apr 29, 2024
Completion
Aug 1, 2024

Study Design

Enrollment
483 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Pre-NDPP
    Presessions + usual care NDPP
  • Active Comparator: Usual care NDPP
    Usual care NDPP only

Primary Outcome Measure

Weight Loss [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Denver HealthDenverColorado80204-

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