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

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Abstract

Background

New York City (NYC) is currently home to the largest Bangladeshi population in the United States (US) at approximately 62,000 individuals. The high prevalence of Type 2 diabetes mellitus (T2DM) among Bangladeshis has been well documented in Bangladesh, as well as in Canada and the United Kingdom (UK). However, little is known about the diabetes prevalence and management practices of US Bangladeshis. This paper describes the protocol for a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in NYC.

Methods/Design

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 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.

Discussion

To our knowledge, this study represents the first attempt to document the efficacy of T2DM management strategies in the NYC Bangladeshi population. Thus, future qualitative and quantitative findings of the submitted protocol will fill an important gap in the health disparities literature.

Trial registration

NCT02041598

Related collections

Most cited references 27

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Body mass index (BMI) is widely used to assess risk for cardiovascular disease and type 2 diabetes. Cut points for the classification of obesity (BMI >30 kg/m2) have been developed and validated among people of European descent. It is unknown whether these cut points are appropriate for non-European populations. We assessed the metabolic risk associated with BMI among South Asians, Chinese, Aboriginals, and Europeans. We randomly sampled 1078 subjects from 4 ethnic groups (289 South Asians, 281 Chinese, 207 Aboriginals, and 301 Europeans) from 4 regions in Canada. Principal components factor analysis was used to derive underlying latent or "hidden" factors associated with 14 clinical and biochemical cardiometabolic markers. Ethnic-specific BMI cut points were derived for 3 cardiometabolic factors. Three primary latent factors emerged that accounted for 56% of the variation in markers of glucose metabolism, lipid metabolism, and blood pressure. For a given BMI, elevated levels of glucose- and lipid-related factors were more likely to be present in South Asians, Chinese, and Aboriginals compared with Europeans, and elevated levels of the blood pressure-related factor were more likely to be present among Chinese compared with Europeans. The cut point to define obesity, as defined by distribution of glucose and lipid factors, is lower by approximately 6 kg/m2 among non-European groups compared with Europeans. Revisions may be warranted for BMI cut points to define obesity among South Asians, Chinese, and Aboriginals. Using these revised cut points would greatly increase the estimated burden of obesity-related metabolic disorders among non-European populations.

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To assess the reliability and validity of measures on the BRFSS, to assist users in evaluating the quality of BRFSS data, and to identify areas for further research. Review and summary of reliability and validity studies of measures on the BRFSS and studies of measures that were the same or similar to those on the BRFSS from other surveys. Measures determined to be of high reliability and high validity were current smoker, blood pressure screening, height, weight, and BMI, and several demographic characteristics. Measures of both moderate reliability and validity included when last mammography was received, clinical breast exam, sedentary lifestyle, intense leisure-time physical activity, and fruit and vegetable consumption. Few measures were of low validity and only one measure was determined to be of low reliability. Several other measures were of high or moderate reliability or validity, but not both. The reliability or validity could not be determined for some measures, primarily due to lack of research. Most questions on the core BRFSS instrument were at least moderately reliable and valid, and many were highly reliable and valid. Additional research is needed for some measures.

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The Hill-Bone Compliance to High Blood Pressure Therapy Scale assesses patient behaviors for three important behavioral domains of high blood pressure treatment: 1) reduced sodium intake; 2) appointment keeping; and 3) medication taking. This scale is comprised of 14 items in three subscales. Each item is a four point Likert type scale. The content validity of the scale was assessed by a relevant literature review and an expert panel, which focused on cultural sensitivity and appropriateness of the instrument for low literacy. Internal consistency reliability and predictive validity of the scale were evaluated using two community based samples of hypertensive adults enrolled in clinical trials of high blood pressure care and control. The standardized alpha for the total scale were 0.74 and 0.84, and the average interitem correlations of the 14 items were 0.18 and 0.28, respectively. The construct and predictive validity of the scale was assessed by factor analysis and by testing of theoretically derived hypotheses regarding whether the scale demonstrated consistent and expected relationships with related variables. In this study, high compliance scale scores predicted significantly lower levels of blood pressure and blood pressure control. Moreover, high compliance scale scores at the baseline were significantly associated with blood pressure control at both baseline and at follow up in the two independent samples. This brief instrument provides a simple method for clinicians in various settings to use to assess patients' self reported compliance levels and to plan appropriate interventions.

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Author and article information

Journal

Journal ID (nlm-ta): BMC Public Health

Journal ID (iso-abbrev): BMC Public Health

Title: BMC Public Health

Publisher: BioMed Central

ISSN (Electronic): 1471-2458

Publication date Collection: 2014

Publication date (Electronic): 18 February 2014

Volume: 14

Page: 177

Affiliations

[1 ]Department of Population Health, New York University School of Medicine, 227 East 30th Street, 8 F, New York, NY 10016, USA

[2 ]Department of Medical Social Sciences, Northwestern University, 750 N Lake Shore, Chicago, IL 60611, USA

[3 ]Psychology Department, State University of New York, 210 Store Hill Road, Old Westbury, NY 11568, USA

Article

Publisher ID: 1471-2458-14-177

DOI: 10.1186/1471-2458-14-177

PMC ID: 3933368

PubMed ID: 24548534

SO-VID: c85702fa-0041-4bda-8df0-fcc9479589b6

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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

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Abstract

Background

Methods/Design

Discussion

Trial registration

Related collections

Global Health Next Generation Network

Most cited references 27

Defining obesity cut points in a multiethnic population.

Reliability and validity of measures from the Behavioral Risk Factor Surveillance System (BRFSS).

Development and testing of the Hill-Bone Compliance to High Blood Pressure Therapy Scale.

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