Pre DiabetesBRIDGENCT05166785
BRInging the Diabetes Prevention Program to GEriatric Populations
A study testing DPP Tailored for Older Adults and delivered via Telehealth and In-Person Diabetes Prevention Program (DPP) in people with Pre Diabetes, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre Diabetes
- What is being tested?
- DPP Tailored for Older Adults and delivered via Telehealth and In-Person Diabetes Prevention Program (DPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2022to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pre Diabetes
- Being tested
- DPP Tailored for Older Adults and delivered via Telehealth, In-Person Diabetes Prevention Program (DPP)
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPP Tailored for Older Adults and delivered via TelehealthOther
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
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)
| Study group | Role | What they receive |
|---|---|---|
| In-person Diabetes Prevention Program (DPP) | Active comparator | Participants randomized to the in-person DPP intervention for 12 months Receives: Other: In-Person Diabetes Prevention Program (DPP) |
| 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. Receives: Other: DPP Tailored for Older Adults and delivered via Telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline visit, 6 months visit, 12 month visit
Secondary outcomes (1)
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.
Measured: Baseline visit, 6 months visit, 12 month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start5 Oct 2022
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabetesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeannette M Beasley, PhD, RDN, Principal investigator, NYU Langone HealthJoshua Chodosh, MD, MHS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05166785
- Sponsor's protocol ID
- 21-01039
- Other IDs
- 1R01DK127916-01A1
- Acronym
- BRIDGE
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2021
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRInging the Diabetes Prevention Program to GEriatric Populations
- ClinicalTrials.gov ID
- NCT05166785
- Acronym / sponsor ID
- BRIDGE / 21-01039
- Conditions
- Pre Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 5 Oct 2022 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person Diabetes Prevention Program (DPP) | Active comparator | Other: In-Person Diabetes Prevention Program (DPP)Participants randomized to the in-person DPP intervention for 12 months |
| DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) | Active comparator | Other: DPP Tailored for Older Adults and delivered via TelehealthParticipants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPP Tailored for Older Adults and delivered via TelehealthDiabetes 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 | Other | DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) |
| In-Person Diabetes Prevention Program (DPP)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) | Other | In-person Diabetes Prevention Program (DPP) |
Primary outcome
Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
Time frame: Baseline visit, 6 months visit, 12 month visit
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
Time frame: Baseline visit, 6 months visit, 12 month visit
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
1 secondary outcome
Adherence to the DPP-TOAT is greater than the in-person DPP
Time frame: Baseline visit, 6 months visit, 12 month visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeannette M Beasley, PhD, RDN principal investigator
NYU Langone Health
Joshua Chodosh, MD, MHS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPP Tailored for Older Adults and delivered via Telehealth and In-Person Diabetes Prevention Program (DPP) in people with Pre Diabetes, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP (time frame: Baseline visit, 6 months visit, 12 month visit). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.