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Completed
NCT05166785
BRInging the Diabetes Prevention Program to GEriatric Populations
Conditions: Pre Diabetes
Sex: All
Ages: 65 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 238
Sponsor: NYU Langone Health
Location: NYU Langone Health New York New York
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Men and women aged 65 years and older
* Diagnosis of pre-diabetes (A1c between 5.7-6.4%, fasting glucose between 100-125 mg/dL, or oral glucose tolerance test between 140-199 mg/dL within past 12 months)
* BMI of greater than or equal to 30
* English-speaking
* Under the care of a Primary care provider (PCP) in the NYU Langone Health system
* Able to travel to NYU Langone for in-person evaluations
* Access to a telephone
* Informed consent
Exclusion Criteria:
* Prevalent diabetes or end-stage renal disease
* Prior participation in the Diabetes Prevention Program
* A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
* Taking FDA-approved weight loss medications
* PCP stating that patient should not participate
* Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
* Severe visual impairment that precludes completion of assessments and/or intervention
Source: ClinicalTrials.gov (NCT05166785). StuddyBuddy aggregates publicly available trial information.