Habit Building Software Application to Increase Engagement of Vulnerable Populations in the National Diabetes Prevention Program (NDPP) Lifestyle Change Program (LCP)

March 24, 2026 updated by: The Institute for Iterative Thinking

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Felton, California, United States, 95018
        • The Institute of Iterative Thinking

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Cohorts and sites enrolled in concurrent, similar health app-based studies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FT LCP
Behavioral: FT LCP
FT LCP is a behavior change software application, used as an adjunct to the standard National Diabetes Prevention Program
No Intervention: Standard LCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement as measured by number of classes attended by participant
Time Frame: From enrollment to end of the Lifestyle Change Program, up to 12 months.
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
Time Frame: From enrollment to end of the Lifestyle Change Program, up to 12 months.
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
Time Frame: From enrollment to end of the Lifestyle Change Program, up to 12 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Institute for Iterative Thinking

Collaborators

Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

April 13, 2022

Study Completion (Actual)

October 12, 2022

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 21, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1300367-20210112
  • 75D30119C06604 (Other Grant/Funding Number: The Centers for Disease Control and Prevention)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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