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

NCT ID: NCT06656273

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-10-12

Brief Summary

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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

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Conditions

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Prediabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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FT LCP

Group Type EXPERIMENTAL

FT LCP

Intervention Type BEHAVIORAL

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

Standard LCP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FT LCP

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

The Institute for Iterative Thinking

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Institute of Iterative Thinking

Felton, California, United States

Site Status

Countries

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United States

Other Identifiers

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75D30119C06604

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1300367-20210112

Identifier Type: -

Identifier Source: org_study_id

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