Presessions for the National Diabetes Prevention Program
Primary Purpose
Prediabetic State, Obesity, Gestational Diabetes
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Presessions
National Diabetes Prevention Program
Sponsored by
About this trial
This is an interventional prevention trial for Prediabetic State
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.
Sites / Locations
- Denver Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pre-NDPP
Usual care NDPP
Arm Description
Presessions + usual care NDPP
Usual care NDPP only
Outcomes
Primary Outcome Measures
Weight loss
Change in body weight
Secondary Outcome Measures
Attendance
Number of sessions attended
Full Information
NCT ID
NCT04022499
First Posted
July 15, 2019
Last Updated
February 14, 2023
Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT04022499
Brief Title
Presessions for the National Diabetes Prevention Program
Official Title
Enhanced Enrollment in the National Diabetes Prevention Program for the Underserved: a Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Denver Health and Hospital Authority
Collaborators
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State, Obesity, Gestational Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
483 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-NDPP
Arm Type
Experimental
Arm Description
Presessions + usual care NDPP
Arm Title
Usual care NDPP
Arm Type
Active Comparator
Arm Description
Usual care NDPP only
Intervention Type
Behavioral
Intervention Name(s)
Presessions
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
National Diabetes Prevention Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight loss
Description
Change in body weight
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Attendance
Description
Number of sessions attended
Time Frame
12 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Based on self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Denver Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32476659
Citation
Ritchie ND, Holtrop JS, Gritz RM, Sauder KA, Durfee MJ, Dickinson LM, Kaufmann PG. Enhanced Enrollment in the National Diabetes Prevention Program to Increase Engagement and Weight Loss for the Underserved: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 1;9(6):e15499. doi: 10.2196/15499.
Results Reference
derived
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Presessions for the National Diabetes Prevention Program
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