Habit Building Software Application to Increase Engagement of Vulnerable Populations in the National Diabetes Prevention Program (NDPP) Lifestyle Change Program (LCP)
Science-based Habit Formation App as an Adjunct to the National Diabetes Prevention Program (DPP) Lifestyle Change Program (LCP) to Increase Engagement, Participation and Outcomes of Underserved Populations and Others Eligible for the DPP LCP
2 other identifiers
interventional
450
1 country
1
Brief Summary
The goal of this clinical trial is to learn whether a companion software application can improve program engagement in the National Diabetes Prevention Program in adults with prediabetes. The main question\[s\] it aims to answer \[is/are\]: Do participants using the software application (the intervention group) have better engagement with the Diabetes Prevention Program than those who do not use the companion software application (the control group)? Are participants using the software application (the intervention group) more likely to stay in the Diabetes Prevention Program longer than those who do not use the companion software application (the control group)? Participants are those who have signed up for their local Diabetes Prevention Program and agree to be in the study.
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 2021
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
Study Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 12, 2022
CompletedFirst Submitted
Initial submission to the registry
October 18, 2024
CompletedFirst Posted
Study publicly available on registry
October 24, 2024
CompletedMarch 27, 2026
March 1, 2026
1.2 years
October 18, 2024
March 24, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Engagement as measured by number of classes attended by participant
The primary measure for participant engagement will be the number of classes attended by a participant.
From enrollment to end of the Lifestyle Change Program, up to 12 months.
Retention as measured by percentage of participants that remain enrolled at end of study
The primary measure for retention will be the percentage of participants that remain enrolled in the LCP at the end of the study period.
From enrollment to end of the Lifestyle Change Program, up to 12 months.
Efficacy as measured by the percentage of participants that achieve the goal of >/= 5% weight loss by end of study
The primary measure of efficacy will be the percentage of participants who reach the LCP goal of ≥5% weight loss by the end of the study period.
From enrollment to end of the Lifestyle Change Program, up to 12 months.
Study Arms (2)
FT LCP
EXPERIMENTALStandard LCP
NO INTERVENTIONInterventions
FT LCP is a behavior change software application, used as an adjunct to the standard National Diabetes Prevention Program
Eligibility Criteria
You may qualify if:
- is eligible for and enrolls in a live or distance LCP at a designated study site during the enrollment period of the study
- has a smartphone or other device able to engage with the FT LCP app
- can read basic 5th grade English, as used in the FT LCP app
You may not qualify if:
- Cohorts and sites enrolled in concurrent, similar health app-based studies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Institute of Iterative Thinking
Felton, California, 95018, United States
Related Publications (1)
Leichter JW, Cannon MJ, Mensa-Wilmot Y, Belay ZW, Garza AS, Schmalz AM, Walch KI, Bobinet K. An iterative mindset approach as an adjunct to the national diabetes prevention program: a randomized trial assessing retention, engagement and weight loss. BMC Digit Health. 2026;4(1):13. doi: 10.1186/s44247-026-00247-y. Epub 2026 Feb 25.
PMID: 41768961DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2024
First Posted
October 24, 2024
Study Start
February 1, 2021
Primary Completion
April 13, 2022
Study Completion
October 12, 2022
Last Updated
March 27, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share