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

Not Applicable

Completed

• Conditions: Prediabetes

• Registration Number: NCT06656273
• Lead Sponsor: The Institute for Iterative Thinking

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-04-13
• Study Completion: 2022-10-12
• Status Verified: 2024-10
• Study First Submitted: 2024-10-18
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-24
• Last Update Posted: 2024-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Engagement	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.
Efficacy	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.
Retention	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.

Trial Locations

Locations (1)

The Institute of Iterative Thinking; 🇺🇸 Felton, California, United States