An interventional study of Presessions and National Diabetes Prevention Program in Prediabetic State, Obesity and Gestational Diabetes, sponsored by Denver Health and Hospital Authority. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Denver Health and Hospital Authority · Not applicable, Interventional, and Prevention
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.
Type 2 diabetes affects 9.4% of US adults with higher rates among racial/ethnic minorities and individuals of low socioeconomic status. The National Diabetes Prevention Program (NDPP) is an evidence-based and widely disseminated behavioral intervention to reduce diabetes incidence through modest weight loss. However, retention in the yearlong NDPP is problematic and leads to suboptimal weight loss, especially among Hispanic, non-Hispanic black, and low-income non-Hispanic white participants. Strategies to improve NDPP engagement and weight loss are needed urgently, especially for these subgroups. Pilot results of the Pre-NDPP, a novel enhancement to enrollment in the NDPP based on the Health Belief Model, were highly successful in a non-randomized cohort study among 1,140 racially diverse, predominately low-income participants. Outcomes of 75 Pre-NDPP participants who enrolled in the NDPP were compared to 1,065 prior participants using ANCOVA and multivariable logistic regression. Pre-session participants stayed in the NDPP 99.8 days longer (p\<.001) and attended 14.3% more sessions (p\<.001) on average than those without a pre-session. Pre-session participants lost 2.0% more weight (p\<.001) and were 3.5 times more likely to achieve the 5% weight loss target (p\<.001). Sensitivity analyses were consistent. Findings suggest pre-sessions may be a promising and pragmatic strategy to improve NDPP effectiveness and mitigate disparities in program outcomes, but a randomized controlled trial (RCT) is needed to determine whether Pre-NDPP reliably improves NDPP outcomes. The purpose of this study is to 1) conduct an RCT comparing NDPP attendance and weight loss outcomes between participants who receive Pre-NDPP vs. direct enrollment into the NDPP (usual care), 2) examine potential effect mediators (perceived risk for developing diabetes and self-efficacy and readiness for weight control) and moderators (race/ethnicity and income level), and 3) evaluate implementation factors, including cost and projected return on investment. The long-term goal is to disseminate a scalable, evidence-based strategy to improve success of the NDPP and reduce disparities in NDPP effectiveness. If found to be effective, Pre-NDPP can be disseminated to all NDPP providers, including more than 1,700 NDPP sites, and may be supported by current NDPP payers such as Medicare, commercial insurers, and employer groups. Thus, this approach has a high potential to impact the burden of type 2 diabetes and related health disparities across the country.
918 studies on the registry are indexed under Prediabetic State; 232 are open to participants now.
This study's enrollment of 483 is above the median of 62 across 762 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →Denver Health and Hospital Authority is the lead sponsor of 84 studies on the registry; 4 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Presessions + usual care NDPP
Behavioral: Presessions · Behavioral: National Diabetes Prevention Program
Usual care NDPP only
Behavioral: National Diabetes Prevention Program
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.
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.
Weight Loss
Percent body weight change from baseline to 12 months
Time frame: 12 months
Weight Loss From First to Last NDPP Session
Percent weight change from the first to last NDPP sessions attended
Time frame: From first session attended to last session attended
≥5% Weight Loss at Any Point in the Program
Dichotomous outcome characterized by achieving or not achieving ≥5% weight loss at any point during the course of program delivery or during the 3 month weight collection period post program.
Time frame: First session attended to 3 months post program
Attended ≥ 1 Class
Enrollees who attended ≥ 1 NDPP class over the course of the 12 month program.
Time frame: Attended ≥ 1 class
Number of Sessions Attended
Number of NDPP sessions attended over the course of the 12 month program
Time frame: 12 months
We will identify potential participants through referrals from Denver Health healthcare providers to the Denver Health NDPP, per routine practice since 2013. Providers refer through the electronic health record (EHR), following email prompts to provider listservs in the preceding months of a new NDPP starting. Recruitment efforts began summer 2019 and concluded winter 2023.
| Milestone | Pre-NDPP | Usual Care NDPP |
|---|---|---|
| Started | 244 | 239 |
| Completed | 236 | 234 |
| Not completed | 8 | 5 |
Percent body weight change from baseline to 12 months
| % of weight loss | Pre-NDPP | Usual Care NDPP |
|---|---|---|
| Weight Loss | 3.1 ± 6.7 | 2.8 ± 6.0 |
Percent weight change from the first to last NDPP sessions attended
Results for this outcome have not been posted.
Dichotomous outcome characterized by achieving or not achieving ≥5% weight loss at any point during the course of program delivery or during the 3 month weight collection period post program.
Results for this outcome have not been posted.
Enrollees who attended ≥ 1 NDPP class over the course of the 12 month program.
Results for this outcome have not been posted.
Number of NDPP sessions attended over the course of the 12 month program
Results for this outcome have not been posted.
Collected over Adverse events were not collected. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-NDPP | — | — | — |
| Usual Care NDPP | — | — | — |
| Age, Continuous(years) | Pre-NDPP | Usual Care NDPP | Total |
|---|---|---|---|
| Mean | 46.6 ± 13 | 47.0 ± 12.9 | 46.8 ± 12.9 |
| Sex: Female, Male(Participants) | Pre-NDPP | Usual Care NDPP | Total |
|---|---|---|---|
| Female | 192 | 190 | 382 |
| Male | 52 | 49 | 101 |
| Race and Ethnicity Not Collected(Participants) | Pre-NDPP | Usual Care NDPP | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Aug 2019 to primary completion in Apr 2024, 56 months.
Results were first posted in Sep 2025, 1 year 4 months after primary completion.
Of 378 non-industry interventional studies with no phase under Prediabetic State, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 39. This study's 56 months is above that.
Counting every sponsor, half of 424 studies reached it within 23 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Denver Health and Hospital Authority