Diabetes Mellitus, Type 2NCT02041598
DREAM Project Community Health Worker Intervention
A study testing CHW Intervention in people with Diabetes Mellitus, Type 2, run by NYU Langone Health at 1 site in United States.
Trial summary
The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC). Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- CHW Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2009to 25 Feb 2016
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- confirmed clinical diagnosis of T2DM with a Hemoglobin A1c (HbA1c) of ≥ 6.5%; and
- male or female between the ages of 21-85 years old; and
- willingness to be randomized to either treatment or control groups.
Who cannot join
- is or was on renal dialysis;
- experiencing an acute or terminal illness or serious mental illness;
- had a history of recent coronary event within the last 3 months of recruitment;
- is pregnant at the time of recruitment;
- experienced other severe medical conditions that might preclude participation;
- has poor short-term prognosis (expected death in <2 years); or
- is participating in another research study.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine, Dept of Population Health
New York, New York, 10016
About this study
The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC).
Read the detailed description
The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC). For a two-arm, randomized controlled trial (RCT), investigators will recruit a sample of 256 participants, all of whom are 1) of Bangladeshi descent, 2) residing in NYC, 3) diagnosed with Type 2 diabetes mellitus (T2DM) and a recent Hemoglobin A1c (HbA1c) of ≥ 6.5, and 4) between the ages of 21-85. The treatment group receives a six-month CHW-led intervention consisting of five monthly group educational sessions, two one-on-one visits, and follow-up phone calls as needed from a CHW. The control group receives an introductory educational session only. Primary and secondary outcomes include clinical and behavioral measures, such as HbA1c and weight change, access to and utilization of care (i.e. appointment keeping and use of specialty care), and knowledge and practice of physical activity and healthful eating. Additionally, information regarding CHW characteristics, the processes and mechanisms for influencing healthful behavior change, and fidelity of the intervention are collected. Outcomes are measured at Baseline, 3-Months, 6-Months for both groups, and at 12-Months for the treatment group.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- CHW Intervention
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW InterventionOther
5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
| Study group | Role | What they receive |
|---|---|---|
| Full CHW Intervention | Experimental | 5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed Receives: Other: CHW Intervention |
| Control: Intro to Diabetes Session Only | No intervention | One-time, Introduction to Diabetes educational session only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Baseline Hemoglobin A1c at 6-Months
Change in Baseline HbA1c at 6-Months
Measured: Baseline, 6-Months
Secondary outcomes (7)
Change in Baseline Perceived Social Support at 6-Months
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Measured: Baseline, 6-Months
Change in Baseline Perceived Benefits & Barriers at 6-Months
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Measured: Baseline, 6-Months
Change in Baseline Self-Efficacy at 6-Months
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Measured: Baseline, 6-Months
Change in Baseline Access to / Utilization of healthcare at 6-Months
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Measured: Baseline, 6-Months
Change in Baseline Diabetic Management Practices & Knowledge at 6-Months
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Measured: Baseline, 6-Months
Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months
Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint
Measured: Baseline, 6-Months
Change in Baseline Lipid Profile at 6-Months
HDL, LDL, Triglycerides, Total Cholesterol
Measured: Baseline, 6-Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study start1 Jul 2009
- Primary completion25 Feb 2016
- Study completion25 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Nadia Islam, PhD, Principal investigator, New York University School of Medicine, Department of Population Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041598
- Sponsor's protocol ID
- 09-0510
- Other IDs
- P60MD000538, U48DP001904
- Status last verified
- Oct 2017
- First submitted
- 16 Jan 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Islam NS, Wyatt LC, Patel SD, Shapiro E, Tandon SD, Mukherji BR, Tanner M, Rey MJ, Trinh-Shevrin C. Evaluation of a community health worker pilot intervention to improve diabetes management in Bangladeshi immigrants with type 2 diabetes in New York City. Diabetes Educ. 2013 Jul-Aug;39(4):478-93. doi: 10.1177/0145721713491438. Epub 2013 Jun 7.
PubMed 23749774Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
PubMed 36273386Islam N, Riley L, Wyatt L, Tandon SD, Tanner M, Mukherji-Ratnam R, Rey M, Trinh-Shevrin C. Protocol for the DREAM Project (Diabetes Research, Education, and Action for Minorities): a randomized trial of a community health worker intervention to improve diabetic management and control among Bangladeshi adults in NYC. BMC Public Health. 2014 Feb 18;14:177. doi: 10.1186/1471-2458-14-177.
PubMed 24548534
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DREAM Project Community Health Worker Intervention
- ClinicalTrials.gov ID
- NCT02041598
- Acronym / sponsor ID
- 09-0510
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 1 Jul 2009 (actual)
- Primary completion
- 25 Feb 2016 (actual)
- Study completion
- 25 Feb 2016 (actual)
- First posted
- 22 Jan 2014 (estimated)
- 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 DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC).
Detailed description
The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC). For a two-arm, randomized controlled trial (RCT), investigators will recruit a sample of 256 participants, all of whom are 1) of Bangladeshi descent, 2) residing in NYC, 3) diagnosed with Type 2 diabetes mellitus (T2DM) and a recent Hemoglobin A1c (HbA1c) of ≥ 6.5, and 4) between the ages of 21-85. The treatment group receives a six-month CHW-led intervention consisting of five monthly group educational sessions, two one-on-one visits, and follow-up phone calls as needed from a CHW. The control group receives an introductory educational session only. Primary and secondary outcomes include clinical and behavioral measures, such as HbA1c and weight change, access to and utilization of care (i.e. appointment keeping and use of specialty care), and knowledge and practice of physical activity and healthful eating. Additionally, information regarding CHW characteristics, the processes and mechanisms for influencing healthful behavior change, and fidelity of the intervention are collected. Outcomes are measured at Baseline, 3-Months, 6-Months for both groups, and at 12-Months for the treatment group.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full CHW Intervention | Experimental | Other: CHW Intervention5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed |
| Control: Intro to Diabetes Session Only | No intervention | –One-time, Introduction to Diabetes educational session only |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- confirmed clinical diagnosis of T2DM with a Hemoglobin A1c (HbA1c) of ≥ 6.5%; and
- male or female between the ages of 21-85 years old; and
- willingness to be randomized to either treatment or control groups.
Key exclusion criteria (7 listed)
- is or was on renal dialysis;
- experiencing an acute or terminal illness or serious mental illness;
- had a history of recent coronary event within the last 3 months of recruitment;
- is pregnant at the time of recruitment;
- experienced other severe medical conditions that might preclude 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 |
|---|---|---|
| CHW Intervention5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period | Other | Full CHW Intervention |
Primary outcome
Change in Baseline Hemoglobin A1c at 6-Months
Time frame: Baseline, 6-Months
Change in Baseline HbA1c at 6-Months
7 secondary outcomes
Change in Baseline Perceived Social Support at 6-Months
Time frame: Baseline, 6-Months
Change in Baseline Perceived Benefits & Barriers at 6-Months
Time frame: Baseline, 6-Months
Change in Baseline Self-Efficacy at 6-Months
Time frame: Baseline, 6-Months
Change in Baseline Access to / Utilization of healthcare at 6-Months
Time frame: Baseline, 6-Months
Change in Baseline Diabetic Management Practices & Knowledge at 6-Months
Time frame: Baseline, 6-Months
Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months
Time frame: Baseline, 6-Months
Change in Baseline Lipid Profile at 6-Months
Time frame: Baseline, 6-Months
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 18 Oct 2017.
- Background: PubMed 23749774Islam NS, Wyatt LC, Patel SD, Shapiro E, Tandon SD, Mukherji BR, Tanner M, Rey MJ, Trinh-Shevrin C. Evaluation of a community health worker pilot intervention to improve diabetes management in Bangladeshi immigrants with type 2 diabetes in New York City. Diabetes Educ. 2013 Jul-Aug;39(4):478-93. doi: 10.1177/0145721713491438. Epub 2013 Jun 7.
- Derived from this study: PubMed 36273386Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
- Derived from this study: PubMed 24548534Islam N, Riley L, Wyatt L, Tandon SD, Tanner M, Mukherji-Ratnam R, Rey M, Trinh-Shevrin C. Protocol for the DREAM Project (Diabetes Research, Education, and Action for Minorities): a randomized trial of a community health worker intervention to improve diabetic management and control among Bangladeshi adults in NYC. BMC Public Health. 2014 Feb 18;14:177. doi: 10.1186/1471-2458-14-177.
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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.
Nadia Islam, PhD principal investigator
New York University School of Medicine, Department of Population 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 CHW Intervention in people with Diabetes Mellitus, Type 2, 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 3 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 18 Oct 2017. 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?
Change in Baseline Hemoglobin A1c at 6-Months (time frame: Baseline, 6-Months). 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 NCT02041598, which also lists 3 linked publications.
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 18 Oct 2017.