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 — BEHAVIORALThe 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 — BEHAVIORALThe 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-NDPPPresessions + usual care NDPP
- Active Comparator: Usual care NDPPUsual care NDPP only
Primary Outcome Measure
Weight Loss [ Time Frame: 12 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Denver Health | Denver | Colorado | 80204 | - |
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