Patient-centered Goal Setting in the National Diabetes Prevention Program
NDPP-Flex
1 other identifier
interventional
214
1 country
1
Brief Summary
This is a cluster-randomized controlled trial of NDPP-Flex versus the standard NDPP to evaluate effects on glycemia, heterogeneity of treatment effects, and mechanisms of change. We will recruit 200 diverse adults with prediabetes (A1C 5.7-6.4%) and normal weight or overweight/obesity. Participants will enroll in classes (N=20) that are randomized to deliver NDPP-Flex or the standard NDPP. The trial is designed to have \>95% power to detect anticipated treatment effects of \~0.2% A1C improvement and \~10% increase in participants who reach normoglycemia compared to the control arm. The study will be conducted in a health system with the 6th largest network of FQHCs in the US (Denver Health) and in partnership with a premier research institution (University of Colorado).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2022
CompletedFirst Posted
Study publicly available on registry
September 29, 2022
CompletedStudy Start
First participant enrolled
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2025
CompletedNovember 14, 2025
January 1, 2025
2.3 years
September 26, 2022
November 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
A1C
Glycated hemoglobin
12 months
Secondary Outcomes (1)
return to normoglycemia
12 months
Study Arms (2)
National Diabetes Prevention Program
ACTIVE COMPARATORThe 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.
NDPP-Flex
EXPERIMENTALNDPP-Flex. The primary difference between NDPP-Flex and the standard NDPP is the approach to goal setting. In NDPP-Flex, coaches use the latest CDC-published curriculum, but adapted such that participants are encouraged to 1) set attainable, individually-tailored goals for risk-reduction, 2) adjust goals over time as needed, and 3) avoid all-or-nothing assessments of goal attainment. At each session, coaches provide a goal setting worksheet (see excerpt) with a simple, fillable format to better accommodate low literacy (e.g., "I will limit my soda and sugary drinks to \_\_ per day").
Interventions
Eligibility Criteria
You may qualify if:
- Established patient at Denver Health
- Age ≥18 years
- English- or Spanish-speaking
- Prediabetes (as defined by A1C of 5.7-6.4%)
- BMI ≥20 kg/m2 (≥18.5 kg/m2 if identifying as Asian)
You may not qualify if:
- Currently pregnant
- Prior participation in the NDPP
- Anti-hyperglycemic medication (e.g., metformin)
- Diabetes (type 1 or 2)
- BMI \<20 kg/m2 (\<18.5 kg/m2 if identifying as Asian)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Denver Health
Denver, Colorado, 80204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rocio Pereira, MD
Denver Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2022
First Posted
September 29, 2022
Study Start
February 1, 2023
Primary Completion
June 4, 2025
Study Completion
October 15, 2025
Last Updated
November 14, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- within 6 months of publication or 18 months of the award end date if the study remains unpublished; indefinite
All de-identified data resulting from ADA-funded research will be shared without compromising human subject protections to an approved open data repository. As appropriate for the research subject matter, data from the proposed study will be added to the PROMIS (Patient-Reported Outcomes Measurement Information System) repository. Recommended by NIH, PROMIS "is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions" (Source: http://www.healthmeasures.net/explore-measurement-systems/promis?tmpl=component). Making study data available on PROMIS is expected to support accessibility and expedient reuse of the data by a broad scientific community.