Clinical trial NCT05166785: BRInging the Diabetes Prevention Program to GEriatric Populations
Official title: BRInging the Diabetes Prevention Program to GEriatric Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pre Diabetes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2021-12-22
Enrollment: 230
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
timeFrame: Baseline visit, 6 months visit, 12 month visit
measure: Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP
timeFrame: Baseline visit, 6 months visit, 12 month visit
Secondary outcomes:
measure: Adherence to the DPP-TOAT is greater than the in-person DPP
timeFrame: Baseline visit, 6 months visit, 12 month visit
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jeannette M Beasley, PhD, RDN
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Joshua Chodosh, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: