Prediabetes
Conditions
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.
Interventions
BEHAVIORALFT LCP
FT LCP is a behavior change software application, used as an adjunct to the standard National Diabetes Prevention Program
Sponsors
The Institute for Iterative Thinking
Centers for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Engagement as measured by number of classes attended by participant | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed