PrediabetesNCT06656273
Habit Building Software Application to Increase Engagement of Vulnerable Populations in the National Diabetes Prevention Program (NDPP) Lifestyle Change Program (LCP)
A study testing FT LCP in people with Prediabetes, run by The Institute for Iterative Thinking at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prediabetes
- What is being tested?
- FT LCP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 12 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cohorts and sites enrolled in concurrent, similar health app-based studies
Trial locations and contacts
1 site in 1 country.
United States1 site
The Institute of Iterative Thinking
Felton, California, 95018
About this study
Official 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
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.
- Conditions
- Prediabetes
- Being tested
- FT LCP
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT LCPBehavioural
FT LCP is a behavior change software application, used as an adjunct to the standard National Diabetes Prevention Program
| Study group | Role | What they receive |
|---|---|---|
| FT LCP | Experimental | Not described Receives: Behavioral: FT LCP |
| Standard LCP | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment to end of the Lifestyle Change Program, up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Feb 2021
- Primary completion13 Apr 2022
- Study completion12 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Institute for Iterative Thinking
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656273
- Sponsor's protocol ID
- 1300367-20210112
- Other IDs
- 75D30119C06604
- Status last verified
- Mar 2026
- First submitted
- 18 Oct 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41768961
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06656273
- Acronym / sponsor ID
- 1300367-20210112
- Conditions
- Prediabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- The Institute for Iterative ThinkingIndustry (pharma, biotech, devices)
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FT LCP | Experimental | Behavioral: FT LCP |
| Standard LCP | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Cohorts and sites enrolled in concurrent, similar health app-based studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT LCPFT LCP is a behavior change software application, used as an adjunct to the standard National Diabetes Prevention Program | Behavioural | FT LCP |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 41768961Leichter 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FT LCP in people with Prediabetes, run by The Institute for Iterative Thinking at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06656273, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.