DREAM Project Community Health Worker Intervention

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: CHW Intervention

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 Type: Interventional
• Enrollment (Actual): 441
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine, Dept of Population Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full CHW Intervention; 5 monthly group educational sessions, 2 1v1 Visits with CHW, Phone Calls as Needed	Other: CHW Intervention; 5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
No Intervention: Control: Intro to Diabetes Session Only; One-time, Introduction to Diabetes educational session only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baseline Hemoglobin A1c at 6-Months	Change in Baseline HbA1c at 6-Months	Baseline, 6-Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Baseline Perceived Social Support at 6-Months	Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint	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	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	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	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	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	Baseline, 6-Months
Change in Baseline Lipid Profile at 6-Months	HDL, LDL, Triglycerides, Total Cholesterol	Baseline, 6-Months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Nadia Islam, PhD, New York University School of Medicine, Department of Population Health

Publications and helpful links

General 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.
• Wyatt 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. 2022 Oct 23. doi: 10.1007/s10903-022-01411-y. Online ahead of print.
• Islam 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): February 25, 2016
• Study Completion (Actual): February 25, 2016

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 22, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 09-0510; P60MD000538 (U.S. NIH Grant/Contract); U48DP001904 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No