ACTIVE_NOT_RECRUITING

BRInging the Diabetes Prevention Program to GEriatric Populations

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

BRInging the Diabetes Prevention Program to GEriatric Populations

Quick Facts

Study Start:2022-10-05
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05166785

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women aged 65 years and older
  2. * 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)
  3. * BMI of greater than or equal to 30
  4. * English-speaking
  5. * Under the care of a Primary care provider (PCP) in the NYU Langone Health system
  6. * Able to travel to NYU Langone for in-person evaluations
  7. * Access to a telephone
  8. * Informed consent
  1. * Prevalent diabetes or end-stage renal disease
  2. * Prior participation in the Diabetes Prevention Program
  3. * A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
  4. * Taking FDA-approved weight loss medications
  5. * PCP stating that patient should not participate
  6. * Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
  7. * Severe visual impairment that precludes completion of assessments and/or intervention

Contacts and Locations

Principal Investigator

Jeannette M Beasley, PhD, RDN
PRINCIPAL_INVESTIGATOR
NYU Langone Health
Joshua Chodosh, MD, MHS
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Jeannette M Beasley, PhD, RDN, PRINCIPAL_INVESTIGATOR, NYU Langone Health
  • Joshua Chodosh, MD, MHS, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-05
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-10-05
Study Completion Date2026-11

Terms related to this study

Additional Relevant MeSH Terms

  • Pre Diabetes