BRInging the Diabetes Prevention Program to GEriatric Populations (BRIDGE)
Primary Purpose
Pre Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DPP Tailored for Older Adults and delivered via Telehealth
In-Person Diabetes Prevention Program (DPP)
Sponsored by
About this trial
This is an interventional treatment trial for Pre Diabetes
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
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
In-person Diabetes Prevention Program (DPP)
DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)
Arm Description
Participants randomized to the in-person DPP intervention for 12 months
Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05166785
First Posted
December 8, 2021
Last Updated
December 23, 2022
Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05166785
Brief Title
BRInging the Diabetes Prevention Program to GEriatric Populations
Acronym
BRIDGE
Official Title
BRInging the Diabetes Prevention Program to GEriatric Populations
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-person Diabetes Prevention Program (DPP)
Arm Type
Active Comparator
Arm Description
Participants randomized to the in-person DPP intervention for 12 months
Arm Title
DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)
Arm Type
Active Comparator
Arm Description
Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months.
Intervention Type
Other
Intervention Name(s)
DPP Tailored for Older Adults and delivered via Telehealth
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
In-Person Diabetes Prevention Program (DPP)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
Description
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
Time Frame
Baseline visit, 6 months visit, 12 month visit
Title
Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP
Description
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
Time Frame
Baseline visit, 6 months visit, 12 month visit
Secondary Outcome Measure Information:
Title
Adherence to the DPP-TOAT is greater than the in-person DPP
Description
This will be measured by the number of group sessions completed by each participant.
Time Frame
Baseline visit, 6 months visit, 12 month visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Taj Adams
Phone
646-501-4681
Email
Bridgestudy@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette M Beasley, PhD, RDN
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD, MHS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Taj Adams
Phone
646-501-4681
Email
Bridgestudy@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Jeannette M Beasley, PhD, RDN
First Name & Middle Initial & Last Name & Degree
Joshua Chodosh, MD, MHS
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
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.
Learn more about this trial
BRInging the Diabetes Prevention Program to GEriatric Populations
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