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OpenTrials
Completed

NCT Number: NCT06656273

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

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Institute of Iterative Thinking

Felton, California, 95018, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FT LCP

Behavioral

FT LCP is a behavior change software application, used as an adjunct to the standard National Diabetes Prevention Program

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

The Institute for Iterative Thinking

Industry

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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