CompletedNot Applicable

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

United States450 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Engagement as measured by number of classes attended by participant

Timeframe: 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

Timeframe: 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

Timeframe: From enrollment to end of the Lifestyle Change Program, up to 12 months.

Trial details

NCT IDNCT06656273

SponsorThe Institute for Iterative Thinking

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-13

View on ClinicalTrials.gov More Prediabetes trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Engagement as measured by number of classes attended by participant

Timeframe: 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

Timeframe: 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

Timeframe: From enrollment to end of the Lifestyle Change Program, up to 12 months.