Gestational Diabetes, Obesity, Prediabetic State
Conditions
Brief 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.
Detailed description
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.
Interventions
BEHAVIORALPresessions
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.
BEHAVIORALNational Diabetes Prevention Program
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.
Sponsors
Denver Health and Hospital Authority
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | 12 months | Percent body weight change from baseline to 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss From First to Last NDPP Session | From first session attended to last session attended | Percent weight change from the first to last NDPP sessions attended |
| ≥5% Weight Loss at Any Point in the Program | First session attended to 3 months post 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. |
| Attended ≥ 1 Class | Attended ≥ 1 class | Enrollees who attended ≥ 1 NDPP class over the course of the 12 month program. |
| Number of Sessions Attended | 12 months | Number of NDPP sessions attended over the course of the 12 month program |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Pre-NDPP Presessions + usual care NDPP | 244 |
| Usual Care NDPP Usual care NDPP only | 239 |
| Total | 483 |
Baseline characteristics
| Characteristic | Pre-NDPP | Usual Care NDPP | Total |
|---|---|---|---|
| Age, Continuous | 46.6 years STANDARD_DEVIATION 13 | 47.0 years STANDARD_DEVIATION 12.9 | 46.8 years STANDARD_DEVIATION 12.9 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 192 Participants | 190 Participants | 382 Participants |
| Sex: Female, Male Male | 52 Participants | 49 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Weight Loss
Percent body weight change from baseline to 12 months
Time frame: 12 months
Population: Patients that were pregnant were excluded from the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-NDPP | Weight Loss | 3.1 % of weight loss | Standard Deviation 6.7 |
| Usual Care NDPP | Weight Loss | 2.8 % of weight loss | Standard Deviation 6 |