Skip to main content
OpenTrials
Completed

NCT Number: NCT02041598

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine, Dept of Population Health

New York, 10016, United States

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). 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CHW Intervention

Other

5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period

Primary outcomes

  1. Change in Baseline Hemoglobin A1c at 6-Months

    Time frame: Baseline, 6-Months

    Change in Baseline HbA1c at 6-Months

Secondary outcomes

  1. Change in Baseline Perceived Social Support at 6-Months

    Time frame: Baseline, 6-Months

    Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint

  2. Change in Baseline Perceived Benefits & Barriers at 6-Months

    Time frame: Baseline, 6-Months

    Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint

  3. Change in Baseline Self-Efficacy at 6-Months

    Time frame: Baseline, 6-Months

    Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint

  4. Change in Baseline Access to / Utilization of healthcare at 6-Months

    Time frame: Baseline, 6-Months

    Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint

  5. Change in Baseline Diabetic Management Practices & Knowledge at 6-Months

    Time frame: Baseline, 6-Months

    Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint

  6. Change in Baseline Engagement in Physical Activity & Healthy eating at 6-Months

    Time frame: Baseline, 6-Months

    Assessed using scale items on questionnaire instrument administered during semi-structured interview at each timepoint

  7. Change in Baseline Lipid Profile at 6-Months

    Time frame: Baseline, 6-Months

    HDL, LDL, Triglycerides, Total Cholesterol

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Jan 22, 2014
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.