DiabetesNCT03708380
Diabetes Prevention for Black Men
A study testing Dietary intervention in people with Diabetes, run by NYU Langone Health at 1 site in United States.
Trial summary
Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Dietary 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
- 25 Mar 2019to 23 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Black or African American men who work as barbers at Black-owned barbershops
- Barbershop clients.
- Workplace in neighborhood geographically identified as having higher diabetes burden
- No prior history of clinical diagnosis of diabetes
- Identified on initial and second point-of-care testing to have an HbA1c of 5.7 or greater
Who cannot join
- Individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care HbA1c testing
- Individuals with a history of food allergies that requires specific dietary restrictions
- Individuals who are not English speaking
- Individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation
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: Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes
Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or prediabetes using point-of-care HbA1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.
- Conditions
- Diabetes
- Being tested
- Dietary 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.
Dietary interventionBehavioural
Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.
| Study group | Role | What they receive |
|---|---|---|
| Dietary intervention | Experimental | Community-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes Receives: Behavioral: Dietary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to the intervention during the initial 60-day period when lunches are provided at no cost
Adherence will be calculated as the proportion of participants continuing to consume at least 80% of the lunch meals at the end of the initial intervention period when lunches will be provided at no cost.
Measured: 60 days
Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own
proportion of participants continue to purchase meals after the initial intervention period when individuals will be given the option to continue the intervention but paying for the lunch meals themselves.
Measured: Until the end of the two year study period
Secondary outcomes (5)
Photographic food and beverage diaries
Study participants will take photos of all food and beverages ingested over a 72-hourperiod to provide quantitative data on baseline dietary patterns
Measured: Baseline
First Point-of-care Hemoglobin A1c (HbA1c) test
This first baseline point-of-care HbA1c test will be used as a reference.
Measured: Baseline
Second Point-of-care HbA1C test
This second baseline point-of-care HbA1c test will be used to identify any changes in glycemic control that developed after initial diagnosis of diabetes or prediabetes by the first point-of-care test.
Measured: Baseline (3-6 months after first test)
Third Point-of-care HbA1C test
This post-treatment HbA1c test will be used to identify whether there was any short-term change in glycemic control after the dietary intervention
Measured: Post treatment (3 months after the intervention)
Fourth Point-of-Care HbA1c Test
This post-treatment HbA1c test will be used to identify whether there was any longer-term change in glycemic control after the dietary intervention
Measured: Post-Treatment (6 to 12 months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start25 Mar 2019
- Primary completion23 Jun 2020
- Study completion23 Jun 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- David Lee, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708380
- Sponsor's protocol ID
- 18-00826
- Other IDs
- R03DK120895
- Status last verified
- Jun 2021
- First submitted
- 14 Sep 2018
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Geographically Targeted and Mixed Methods Approach to Improve Glycemic Control Among Black Men Identified as Having Previously Undiagnosed Diabetes and Prediabetes
- ClinicalTrials.gov ID
- NCT03708380
- Acronym / sponsor ID
- 18-00826
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 16 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 23 Jun 2020 (actual)
- First posted
- 17 Oct 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.
Geographic analyses of diabetes burden have found that poor glycemic control, high rates of diabetes-related hospital utilization, and a high prevalence of microvascular diabetic complications all cluster in the same neighborhoods.This proposed study seeks to identify Black barbers with undiagnosed diabetes or prediabetes using point-of-care HbA1c testing, perform qualitative interviews to identify health behaviors that may explain poor sugar control, and develop a workplace-based food intervention to promote primary prevention and test its effect on sugar control in these individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary intervention | Experimental | Behavioral: Dietary interventionCommunity-based dietary intervention to Black and African American barbers identified as having previously undiagnosed diabetes and prediabetes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Black or African American men who work as barbers at Black-owned barbershops
- Barbershop clients.
- Workplace in neighborhood geographically identified as having higher diabetes burden
- No prior history of clinical diagnosis of diabetes
- Identified on initial and second point-of-care testing to have an HbA1c of 5.7 or greater
Key exclusion criteria (4 listed)
- Individuals with a history of blood loss or blood disorder that would lead to incorrect results on point-of care HbA1c testing
- Individuals with a history of food allergies that requires specific dietary restrictions
- Individuals who are not English speaking
- Individuals who have a significant cognitive impairment that will be a barrier to communication, valid consent and participation
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 |
|---|---|---|
| Dietary interventionOver a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets. | Behavioural | Dietary intervention |
Primary outcome
Adherence to the intervention during the initial 60-day period when lunches are provided at no cost
Time frame: 60 days
Adherence will be calculated as the proportion of participants continuing to consume at least 80% of the lunch meals at the end of the initial intervention period when lunches will be provided at no cost.
Continuation with the dietary intervention after initial period when study participants may choose to pay for meals developed on their own
Time frame: Until the end of the two year study period
proportion of participants continue to purchase meals after the initial intervention period when individuals will be given the option to continue the intervention but paying for the lunch meals themselves.
5 secondary outcomes
Photographic food and beverage diaries
Time frame: Baseline
First Point-of-care Hemoglobin A1c (HbA1c) test
Time frame: Baseline
Second Point-of-care HbA1C test
Time frame: Baseline (3-6 months after first test)
Third Point-of-care HbA1C test
Time frame: Post treatment (3 months after the intervention)
Fourth Point-of-Care HbA1c Test
Time frame: Post-Treatment (6 to 12 months after the intervention)
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared.
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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.
David Lee, MD 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 Dietary 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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 11 Jun 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 was stopped early (reason given: COVID-19). Results are not available in the source record.
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?
Adherence to the intervention during the initial 60-day period when lunches are provided at no cost (time frame: 60 days). 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 11 Jun 2021.