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| ID | Type | Description | Link |
|---|---|---|---|
| 75D30119C06604 | Other Grant/Funding Number | The Centers for Disease Control and Prevention |
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FT LCP | Experimental |
| |
| Standard LCP | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT LCP | Behavioral | FT LCP is a behavior change software application, used as an adjunct to the standard National Diabetes Prevention Program |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From enrollment to end of the Lifestyle Change Program, up to 12 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Institute of Iterative Thinking | Felton | California | 95018 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41768961 | Derived | 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. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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