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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK127916-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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Over 24 million Americans are over 65 years and have prediabetes. Prediabetes can be addressed using a public health approach: among the 20% of participants in the Diabetes Prevention Program (DPP) who were ages 60 and over, the diet and physical activity intervention conferred a 71% risk reduction of diabetes after an average follow-up of 3 years. The population of older adults is projected to more than double from 52.5 million in 2019 to ~100 million by 2060, and if projections hold, about half (48.3%) will have prediabetes. The proposed hybrid effectiveness implementation type 1 design will compare a DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) to an in person DPP tailored for older adults (DPP arm) using a randomized, controlled trial design (n=230). The preliminary data suggests DPP-TOAT is a feasible and acceptable way to deliver the DPP to older adults, and this will be the first study to compare the effectiveness and implementation of two strategies (telehealth versus in-person) to deliver a tailored DPP for the unique needs of the growing population of older adults.
Eligible patients will be recruited through electronic health records (Epic and MyChart) and randomized to the 12-month DPP-TOAT or the in-person DPP program. Primary effectiveness outcome will be 6-month weight loss and implementation outcome will be attendance. A pragmatic approach will be used in order to inform future studies conducted in community-based and rural settings. Findings will inform best practices in the delivery of an evidence-based intervention that could reach the 30+ million adults aged 65 and over with prediabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In-person Diabetes Prevention Program (DPP) | Active Comparator | Participants randomized to the in-person DPP intervention for 12 months |
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| DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) | Active Comparator | Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DPP Tailored for Older Adults and delivered via Telehealth | Other | Diabetes Prevention Program (DPP) Tailored for Older Adults and delivered via Telehealth (DPP-TOAT) will be composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP | In-person outcome assessment visits at the New York University Langone research clinic to measure weight at baseline, 6, and 12 months among all randomized participants | Baseline visit, 6 months visit, 12 month visit |
| Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP | In-person outcome assessment visits at New York University Langone research clinic to measure glycemia at baseline, 6, and 12 months among all randomized participants | Baseline visit, 6 months visit, 12 month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the DPP-TOAT is greater than the in-person DPP | This will be measured by the number of group sessions completed by each participant. | Baseline visit, 6 months visit, 12 month visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannette M Beasley, PhD, RDN | NYU Langone Health | Principal Investigator |
| Joshua Chodosh, MD, MHS | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Data collected from this study include anthropometric and blood draw data that will be uploaded to the participants' electronic medical record and questionnaire data that will only be used for study-related purposes.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 2, 2022 | Dec 15, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000375 | Aging |
| ID | Term |
|---|---|
| D048788 | Growth and Development |
| D010829 | Physiological Phenomena |
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| In-Person Diabetes Prevention Program (DPP) | Other | Diabetes Prevention Program (DPP) is composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions over 12 months in person approved by the Centers for Disease Control and Prevention (CDC) |
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