DiabetesBRIDGENCT03524404
BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT
A study testing 6 Week Intervention in people with Diabetes, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center members. The intervention will be conducted through 6 weekly webinars with a certified DPP coach. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- 6 Week Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 15 Apr 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age ≥ 60 years
- Diabetes Risk Score >=5
Who cannot join
- Decisional incapacity to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: BRInging the Diabetes Prevention Program to GEriatric Populations(BRIDGE): a Pilot Study to Test the Usability and Effectiveness of a Telehealth Adaption of the Diabetes Prevention Program (DPP) in a Community of Older Adults
The purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center members. The intervention will be conducted through 6 weekly webinars with a certified DPP coach. Participants will receive a binder and physical activity tracker to complete self-monitoring of diet and physical activity. The primary outcome is feasibility and acceptability of the intervention measured by workshop attendance and focus group feedback. Secondary outcomes include changes in diet, physical activity, and weight.
- Conditions
- Diabetes
- Being tested
- 6 Week Intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 Week InterventionBehavioural
Weekly interactive webinars based on the DPP curriculum at senior center.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes Prevention Program (DPP) | Experimental | Live stream the first six sessions of the Diabetes Prevention Program (DPP) curriculum to Senior Planet on a weekly basis, The webinars will be about 1 hour long, led by a certified DPP educator, and live-streamed to the senior center. Participants will have weekly weigh-ins and meet with a research assistant led focus group following two out of the six sessions to discuss program acceptability. Receives: Behavioral: 6 Week Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Program engagement
calculated by subtracting attending study visits from those enrolled
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start28 Mar 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeannette Beasley, MD, Principal investigator, Jeannette.Beasley@nyumc.org
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03524404
- Sponsor's protocol ID
- 18-00229
- Acronym
- BRIDGE
- Status last verified
- Nov 2021
- First submitted
- 2 May 2018
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beasley JM, Kirshner L, Wylie-Rosett J, Sevick MA, DeLuca L, Chodosh J. BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study. Pilot Feasibility Stud. 2019 Nov 11;5:129. doi: 10.1186/s40814-019-0513-7. eCollection 2019.
PubMed 31741744
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRInging the Diabetes Prevention Program to GEriatric Populations(BRIDGE): a Pilot Study to Test the Usability and Effectiveness of a Telehealth Adaption of the Diabetes Prevention Program (DPP) in a Community of Older Adults
- ClinicalTrials.gov ID
- NCT03524404
- Acronym / sponsor ID
- BRIDGE / 18-00229
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 14 May 2018 (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.
The purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center members. The intervention will be conducted through 6 weekly webinars with a certified DPP coach. Participants will receive a binder and physical activity tracker to complete self-monitoring of diet and physical activity. The primary outcome is feasibility and acceptability of the intervention measured by workshop attendance and focus group feedback. Secondary outcomes include changes in diet, physical activity, and weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes Prevention Program (DPP) | Experimental | Behavioral: 6 Week InterventionLive stream the first six sessions of the Diabetes Prevention Program (DPP) curriculum to Senior Planet on a weekly basis, The webinars will be about 1 hour long, led by a certified DPP educator, and live-streamed to the senior center. Participants will have weekly weigh-ins and meet with a research assistant led focus group following two out of the six sessions to discuss program acceptability. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women age ≥ 60 years
- Diabetes Risk Score >=5
Key exclusion criteria (1 listed)
- Decisional incapacity to consent
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 |
|---|---|---|
| 6 Week InterventionWeekly interactive webinars based on the DPP curriculum at senior center. | Behavioural | Diabetes Prevention Program (DPP) |
Primary outcome
Program engagement
Time frame: 8 Weeks
calculated by subtracting attending study visits from those enrolled
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 16 Nov 2021.
- Derived from this study: PubMed 31741744Beasley JM, Kirshner L, Wylie-Rosett J, Sevick MA, DeLuca L, Chodosh J. BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study. Pilot Feasibility Stud. 2019 Nov 11;5:129. doi: 10.1186/s40814-019-0513-7. eCollection 2019.
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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 Beasley, MD principal investigator
Jeannette.Beasley@nyumc.org
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 Week Intervention in people with 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 2 inclusion and 1 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 16 Nov 2021. 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?
Program engagement (time frame: 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03524404, which also lists 1 linked publication.
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 16 Nov 2021.