Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies.

Racial/ethnic minorities have demonstrated lower rates of physical activity (PA) than non-Hispanic Whites. This study examined outcomes in PA measures after participation in a community health worker (CHW) intervention. We performed a secondary data analysis from four randomized controlled trials utilizing CHWs (n = 842) in New York City (Bangladeshi-diabetes management, Filipino-hypertension management, and Korean and Asian Indian-diabetes prevention). Outcomes included total weekly PA, PA self-efficacy, PA barriers, and PA social interaction. Each measure was examined at baseline and study endpoint. Generalized estimating equation models were fitted to assess the repeated measures over time, while accounting for study group and socio-demographic factors. Moderate PA, recommended PA, and self-efficacy increased significantly among treatment group participants. PA social interaction increased significantly among Filipinos and Asian Indians. In adjusted regression analysis, time x group interaction was significant for all PA outcomes except for PA barriers. Culturally-adapted lifestyle interventions may potentially improve PA-related outcomes in Asian immigrant communities. Trial registration at ClinicalTrials.gov includes: NCT03530579 (RICE Project), NCT02041598 (DREAM Project), and NCT03100812 (AsPIRE).

Antemortem detection of Parkinson's disease pathology in peripheral biopsies using artificial intelligence.

The diagnosis of Parkinson's disease (PD) is challenging at all stages due to variable symptomatology, comorbidities, and mimicking conditions. Postmortem assessment remains the gold standard for a definitive diagnosis. While it is well recognized that PD manifests pathologically in the central nervous system with aggregation of α-synuclein as Lewy bodies and neurites, similar Lewy-type synucleinopathy (LTS) is additionally found in the peripheral nervous system that may be useful as an antemortem biomarker. We have previously found that detection of LTS in submandibular gland (SMG) biopsies is sensitive and specific for advanced PD; however, the sensitivity is suboptimal especially for early-stage disease. Further, visual microscopic assessment of biopsies by a neuropathologist to identify LTS is impractical for large-scale adoption. Here, we trained and validated a convolutional neural network (CNN) for detection of LTS on 283 digital whole slide images (WSI) from 95 unique SMG biopsies. A total of 8,450 LTS and 35,066 background objects were annotated following an inter-rater reliability study with Fleiss Kappa = 0.72. We used transfer learning to train a CNN model to classify image patches (151 × 151 pixels at 20× magnification) with and without the presence of LTS objects. The trained CNN model showed the following performance on image patches: sensitivity: 0.99, specificity: 0.99, precision: 0.81, accuracy: 0.99, and F-1 score: 0.89. We further tested the trained network on 1230 naïve WSI from the same cohort of research subjects comprising 42 PD patients and 14 controls. Logistic regression models trained on features engineered from the CNN predictions on the WSI resulted in sensitivity: 0.71, specificity: 0.65, precision: 0.86, accuracy: 0.69, and F-1 score: 0.76 in predicting clinical PD status, and 0.64 accuracy in predicting PD stage, outperforming expert neuropathologist LTS density scoring in terms of sensitivity but not specificity. These findings demonstrate the practical utility of a CNN detector in screening for LTS, which can translate into a computational tool to facilitate the antemortem tissue-based diagnosis of PD in clinical settings.

Video-based Parkinson's disease assessments in a nationwide cohort of Fox Insight participants.

INTRODUCTION: Parkinson's disease (PD) research is hampered by slow, inefficient recruitment and burdensome in-person assessments that may be challenging to conduct in a world affected by COVID-19. Fox Insight is an ongoing prospective clinical research study that enables individuals to participate in clinical research from their own homes by completing online questionnaires. To date, over 45,000 participants with and without PD have enrolled. We sought to validate self-reported PD diagnosis in the Fox Insight cohort, assess the validity of other self-reported health information, and evaluate the willingness of participants to participate in video-based research studies. METHODS: Individuals with and without self-reported PD enrolled in Fox Insight were invited to participate in this virtual research study. Participants completed online questionnaires and two virtual visits, during which we conducted standard cognitive and motor assessments. A movement disorder expert determined the most likely diagnosis, which was compared to self-reported diagnosis. RESULTS: A total of 203 participants from 40 U.S. states, 159 with remote clinician-determined PD and 44 without, completed the study (59% male, mean (SD) age 65.7 (9.8)). Level of agreement between self-reported PD diagnosis in Fox Insight and clinician-determined diagnosis was very good ((kappa = 0.85, 95% CI 0.76-0.94). Overall, 97.9% of participants were satisfied with the study, 98.5% were willing to participate in a future observational study with virtual visits, and 76.1% were willing to participate in an interventional trial with virtual visits. CONCLUSION: Among the Fox Insight cohort, self-reported diagnosis is accurate and interest in virtual research studies is high.

In vivo distribution of α-synuclein in multiple tissues and biofluids in Parkinson disease.

OBJECTIVE: The Systemic Synuclein Sampling Study (S4) measured α-synuclein in multiple tissues and biofluids within the same patients with Parkinson disease (PD) vs healthy controls (HCs). METHODS: S4 was a 6-site cross-sectional observational study of participants with early, moderate, or advanced PD and HCs. Motor and nonmotor measures and dopamine transporter SPECT were obtained. Biopsies of skin, colon, submandibular gland (SMG), CSF, saliva, and blood were collected. Tissue biopsy sections were stained with 5C12 monoclonal antibody against pathologic α-synuclein; digital images were interpreted by neuropathologists blinded to diagnosis. Biofluid total α-synuclein was quantified using ELISA. RESULTS: The final cohort included 59 patients with PD and 21 HCs. CSF α-synuclein was lower in patients with PD vs HCs; sensitivity/specificity of CSF α-synuclein for PD diagnosis was 87.0%/63.2%, respectively. Sensitivity of α-synuclein immunoreactivity for PD diagnosis was 56.1% for SMG and 24.1% for skin; specificity was 92.9% and 100%, respectively. There were no significant relationships between different measures of α-synuclein within participants. CONCLUSIONS: S4 confirms lower total α-synuclein levels in CSF in patients with PD compared to HCs, but specificity is low. In contrast, α-synuclein immunoreactivity in skin and SMG is specific for PD but sensitivity is low. Relationships within participants across different tissues and biofluids could not be demonstrated. Measures of pathologic forms of α-synuclein with higher accuracy are critically needed. CLASSIFICATION OF EVIDENCE: This study provides Class III evidence that total CSF α-synuclein does not accurately distinguish patients with PD from HCs, and that monoclonal antibody staining for SMG and skin total α-synuclein is specific but not sensitive for PD diagnosis.

Innovative Recruitment Strategies to Increase Diversity of Participation in Parkinson's Disease Research: The Fox Insight Cohort Experience.

BACKGROUND: Clinical research in Parkinson's disease (PD) faces practical and ethical challenges due to two interrelated problems: participant under-recruitment and lack of diversity. Fox Insight (FI) is a web-based longitudinal study collecting patient-reported outcomes and genetic data worldwide to inform therapeutic studies. FI's online platform provides an opportunity to evaluate online strategies for recruiting large, diverse research cohorts. OBJECTIVE: This project aimed to determine 1) whether FI's digital marketing was associated with increased enrollment overall and from under-represented patient groups, compared to traditional recruitment methods; 2) the clinical and demographic characteristics of samples recruited online, and 3) the cost of this online recruitment. METHOD: FI recruitment during a 6-week baseline period without digital promotion was compared to recruitment during several periods of digital outreach. Separate online recruiting intervals included general online study promotion and unique Facebook and Google ad campaigns targeting under-represented subgroups: early PD, late/advanced PD, and residents of underrepresented/rural geographic areas. RESULTS: Early PD, late PD, and geotargeting campaigns enrolled more individuals in their respective cohorts compared to baseline. All online campaigns also yielded greater total FI enrollment, attracting more participants who were non-White, Hispanic, older, female, and had lower educational attainment and income, and more medical comorbidities. Cost per new participant ranged from $21 (Facebook) to $108 (Google). CONCLUSION: Digital marketing may allow researchers to increase, accelerate, and diversify recruitment for PD clinical studies, by tailoring digital ads to target PD cohort characteristics.

Human Peripheral Blood Neutrophil Isolation for Interrogating the Parkinson's Associated LRRK2 Kinase Pathway by Assessing Rab10 Phosphorylation.

The leucine rich repeat kinase 2 (LRRK2) is the most frequently mutated gene in hereditary Parkinson' disease (PD) and all pathogenic LRRK2 mutations result in hyperactivation of its kinase function. Here, we describe an easy and robust assay to quantify LRRK2 kinase pathway activity in human peripheral blood neutrophils by measuring LRRK2-controlled phosphorylation of one of its physiological substrates, Rab10 at threonine 73. The immunoblotting analysis described requires a fully selective and phosphospecific antibody that recognizes the Rab10 Thr73 epitope phosphorylated by LRRK2, such as the MJFF-pRab10 rabbit monoclonal antibody. It uses human peripheral blood neutrophils, because peripheral blood is easily accessible and neutrophils are an abundant and homogenous constituent. Importantly, neutrophils express relatively high levels of both LRRK2 and Rab10. A potential drawback of neutrophils is their high intrinsic serine protease activity, which necessitates the use of very potent protease inhibitors such as the organophosphorus neurotoxin diisopropylfluorophosphate (DIFP) as part of the lysis buffer. Nevertheless, neutrophils are a valuable resource for research into LRRK2 kinase pathway activity in vivo and should be considered for inclusion into PD biorepository collections.

Fox Insight collects online, longitudinal patient-reported outcomes and genetic data on Parkinson's disease.

Fox Insight is an online, longitudinal health study of people with and without Parkinson's disease with targeted enrollment set to at least 125,000 individuals. Fox Insight data is a rich data set facilitating discovery, validation, and reproducibility in Parkinson's disease research. The dataset is generated through routine longitudinal assessments (health and medical questionnaires evaluated at regular cycles), one-time questionnaires about environmental exposure and healthcare preferences, and genetic data collection. Qualified Researchers can explore, analyze, and download patient-reported outcomes (PROs) data and Parkinson's disease- related genetic variants at https://foxden.michaeljfox.org. The full Fox Insight genetic data set, including approximately 600,000 single nucleotide polymorphisms (SNPs), can be requested separately with institutional review and are described outside of this data descriptor.

Comparison of an Online-Only Parkinson's Disease Research Cohort to Cohorts Assessed In Person.

BACKGROUND: Online tools for data collection could be of value in patient-oriented research. The Fox Insight (FI) study collects data online from individuals with self-reported Parkinson's disease (PD). Comparing the FI cohort to other cohorts assessed through more traditional (in-person) observational research studies would inform the representativeness and utility of FI data. OBJECTIVE: To compare self-reported demographic characteristics, symptoms, medical history, and PD medication use of the FI PD cohort to other recent observational research study cohorts assessed with in-person visits. METHODS: The FI PD cohort (n = 12,654) was compared to 3 other cohorts, selected based on data accessibility and breadth of assessments: Parkinson's Progression Markers Initiative (PPMI; PD n = 422), Parkinson's Disease Biomarker Program (PDBP; n = 700), and PD participants in the LRRK2 consortium without LRRK2 mutations (n = 508). Demographics, motor and non-motor assessments, and medications were compared across cohorts. Where available, identical items on surveys and assessments were compared; otherwise, expert opinion was used to determine comparable definitions for a given variable. RESULTS: The proportion of females was significantly higher in FI (45.56%) compared to PPMI (34.36%) and PDBP (35.71%). The FI cohort had greater educational attainment as compared to all other cohorts. Overall, prevalence of difficulties with motor experiences of daily living and non-motor symptoms in the FI cohort was similar to other cohorts, with only a few significant differences that were generally small in magnitude. Missing data were rare for the FI cohort, except on a few variables. DISCUSSION: Patterns of responses to patient-reported assessments obtained online on the PD cohort of the FI study were similar to PD cohorts assessed in-person.

Feasibility and Safety of Multicenter Tissue and Biofluid Sampling for α-Synuclein in Parkinson's Disease: The Systemic Synuclein Sampling Study (S4).

BACKGROUND: α-synuclein is a lead Parkinson's disease (PD) biomarker. There are conflicting reports regarding accuracy of α-synuclein in different tissues and biofluids as a PD biomarker, and the within-subject anatomical distribution of α-synuclein is not well described. The Systemic Synuclein Sampling Study (S4) aims to address these gaps in knowledge. The S4 is a multicenter, cross-sectional, observational study evaluating α-synuclein in multiple tissues and biofluids in PD and healthy controls (HC). OBJECTIVE: To describe the baseline characteristics of the S4 cohort and safety and feasibility of this study. METHODS: Participants underwent motor and non-motor clinical assessments, dopamine transporter SPECT, biofluid collection (cerebrospinal fluid, saliva, and blood), and tissue biopsies (skin, sigmoid colon, and submandibular gland). Biopsy adequacy was determined based on presence of adequate target tissue. Tissue sections were stained with the 5C12 monoclonal antibody against unmodified α-synuclein. All specimens were acquired and processed in a standardized manner. Adverse events were systematically recorded. RESULTS: The final cohort consists of 82 participants (61 PD, 21 HC). In 68 subjects (83%), all types of specimens were obtained but only 50 (61%) of subjects had all specimens both collected and evaluable for α-synuclein. Mild adverse events were common, especially for submandibular gland biopsy, but only 1 severe adverse event occurred. CONCLUSION: Multicenter tissue and biofluid sampling for α-synuclein is feasible and generally safe. S4 will inform understanding of the concurrent distribution of α-synuclein pathology and biomarkers in biofluids and peripheral nervous system in PD.

Applying a community-based participatory research framework to patient and family engagement in the development of patient-centered outcomes research and practice.

There has been increasing recognition of the need to engage patients, families, and other patient stakeholders in research. This article seeks to provide understanding and examples of how to apply core principles of community-based participatory research (CBPR) in developing patient-centered outcomes research (PCOR) that can impact clinical and public health practice. Authors review CBPR principles and demonstrate how to translate them into effective PCOR strategies. Common themes of CBPR principles and PCOR strategies are related to: (a) fostering joint ownership in the identification of health priorities, the development and evaluation of research strategies and their design, and the dissemination of findings; (b) a keen recognition and appreciation for the importance of stakeholder-driven priorities, research, and solutions; (c) building capacity of both stakeholders and researchers to engage in research collaboratively; and (d) recognizing that conducting the research is not the endpoint but continues on with a commitment to dissemination, spread, adoption and sustainability. The authors highlight the specific strategies in which these CBPR principles can be translated for use in engaging patients and families, and including other stakeholders such as care providers, community partner organizations, health systems, and insurers, in the research process to ensure the development of PCOR.

Immunohistochemical Method and Histopathology Judging for the Systemic Synuclein Sampling Study (S4).

Immunohistochemical (IHC) α-synuclein (Asyn) pathology in peripheral biopsies may be a biomarker of Parkinson disease (PD). The multi-center Systemic Synuclein Sampling Study (S4) is evaluating IHC Asyn pathology within skin, colon and submandibular gland biopsies from 60 PD and 20 control subjects. Asyn pathology is being evaluated by a blinded panel of specially trained neuropathologists. Preliminary work assessed 2 candidate immunoperoxidase methods using a set of PD and control autopsy-derived sections from formalin-fixed, paraffin-embedded blocks of the 3 tissues. Both methods had 100% specificity; one, utilizing the 5C12 monoclonal antibody, was more sensitive in skin (67% vs 33%), and was chosen for further use in S4. Four trainee neuropathologists were trained to perform S4 histopathology readings; in subsequent testing, their scoring was compared to that of the trainer neuropathologist on both glass slides and digital images. Specificity and sensitivity were both close to 100% with all readers in all tissue types on both glass slides and digital images except for skin, where sensitivity averaged 75% with digital images and 83.5% with glass slides. Semiquantitative (0-3) density score agreement between trainees and trainer averaged 67% for glass slides and 62% for digital images.

A Culturally Tailored Community Health Worker Intervention Leads to Improvement in Patient-Centered Outcomes for Immigrant Patients With Type 2 Diabetes.

IN BRIEF This article reports results from a patient-centered intervention to improve management of type 2 diabetes in the New York City Bangladeshi community. The DREAM (Diabetes Research, Education, and Action for Minorities) intervention is a randomized trial among Bangladeshi immigrants with type 2 diabetes comparing those enrolled in a community health worker (CHW) intervention to those in usual care. Participants in the intervention group received five group-based educational sessions and two one-on-one visits delivered by a trained CHW, whereas those in the control group received only the first group educational session. Main outcomes include changes in A1C, systolic and diastolic blood pressure, cholesterol, triglycerides, weight, BMI, and patient-centered outcomes such as knowledge and behavior related to type 2 diabetes management.

Evaluating community health workers' attributes, roles, and pathways of action in immigrant communities.

Community health workers (CHWs) are uniquely positioned to improve health outcomes in immigrant communities; however, research on appropriate metrics for evaluating CHW attributes and mechanisms of effectiveness are limited. The objective of this paper is to characterize CHW attributes and pathways of action using adapted measures, develop a scale using these measures, and explore how findings can inform future CHW research and practice. The study analyzed pre- and post-intervention group data from one quasi-experimental and three randomized controlled-design parent trials assessing the impact of CHW-led group and individual health coaching on various health outcomes in four New York City immigrant communities. We conducted descriptive, bi-variate and principal components analysis to develop a 13-item scale assessing CHW attributes, roles, and pathways of action. The sample included 437 individuals completing the intervention arm of a CHW study. We found CHWs were reported to affect change through a number of mechanisms and participants expressed substantial communal concordance with the CHWs in terms of country of birth, language, and culture. Principal components analysis with promax rotation identified 13 items with three factors and high Cronbach's alphas: 1) valued interpersonal attributes of the CHW (alpha=0.784); 2) CHW as a bridge to health and non-health resources (alpha=0.857); and 3) providing accessibility beyond health providers (alpha=0.904). Socio-demographic characteristics and differences in CHW pathways of action were identified by community. Study findings can guide improved selection and training of CHWs. Further, measures identified in the principal components analysis can be used to guide future CHW evaluation efforts.

A Place-Based Community Health Worker Program: Feasibility and Early Outcomes, New York City, 2015.

INTRODUCTION: This study examined feasibility of a place-based community health worker (CHW) and health advocate (HA) initiative in five public housing developments selected for high chronic disease burden and described early outcomes. METHODS: This intervention was informed by a mixed-method needs assessment performed December 2014-January 2015 (representative telephone survey, n=1,663; six focus groups, n=55). Evaluation design was a non-randomized, controlled quasi-experiment. Intake and 3-month follow-up data were collected February-December 2015 (follow-up response rate, 93%) on 224 intervention and 176 comparison participants, and analyzed in 2016. All participants self-reported diagnoses of hypertension, diabetes, or asthma. The intervention consisted of chronic disease self-management and goal setting through six individual CHW-led health coaching sessions, instrumental support, and facilitated access to insurance/clinical care navigation from community-based HAs. Feasibility measures included CHW service satisfaction and successful goal setting. Preliminary outcomes included clinical measures (blood pressure, BMI); disease management behaviors and self-efficacy; and preventive behaviors (physical activity). RESULTS: At the 3-month follow-up, nearly all intervention participants reported high satisfaction with their CHW (90%) and HA (76%). Intervention participants showed significant improvements in self-reported physical activity (p=0.005) and, among hypertensive participants, self-reported routine blood pressure self-monitoring (p=0.013) compared with comparison participants. No improvements were observed in self-efficacy or clinical measures at the 3-month follow-up. CONCLUSIONS: Housing-based initiatives involving CHW and HA teams are acceptable to public housing residents and can be effectively implemented to achieve rapid improvements in physical activity and chronic disease self-management. At 3-month assessment, additional time and efforts are required to improve clinical outcomes.

Understanding Barriers and Facilitators to Breast and Cervical Cancer Screening among Muslim Women in New York City: Perspectives from Key Informants.

BACKGROUND: Muslims are one of the fastest growing religious groups in the US. However, little is known about their health disparities, and how their unique cultural, religious, and social beliefs and practices affect health behaviors and outcomes. Studies demonstrate Muslim women may have lower rates of breast and cervical cancer screening compared to the overall population. METHODS: The purpose of this study was to: 1) conduct key-informant interviews with Muslim community leaders in New York City (NYC), to understand contextual factors that impact Muslim women's beliefs and practices regarding breast and cervical cancer screening; and 2) inform the development and implementation of a research study on breast and cervical cancer screening among Muslims. Twelve key-informant interviews were conducted. The sample included imams, female religious leaders, physicians, community-based organization leaders, and social service representatives. The interview guide assessed: 1) unique healthcare barriers faced by Muslim women; 2) cultural and social considerations in conducting research; 3) potential strategies for increasing screening in this population; and 4) content and venues for culturally tailored programming and messaging. RESULTS: Key informants noted structure and culture as barriers and religion as a facilitator to breast and cervical cancer screening. Themes regarding the development of targeted health campaigns to increase screening included the importance of educational and in-language materials and messaging, and engaging mosques and religious leaders for dissemination. CONCLUSION: Although Muslim women face a number of barriers to screening, religious beliefs and support structures can be leveraged to facilitate screening and enhance the dissemination and promotion of screening.

Using Qualitative Methods to Understand Physical Activity and Weight Management Among Bangladeshis in New York City, 2013.

INTRODUCTION: South Asians experience high rates of cardiovascular disease and type 2 diabetes, coupled with low rates of reported physical activity. We report findings from a qualitative sub-study that was conducted in 2013 among Bangladeshi immigrants in New York City to understand factors that affect physical activity practices and weight management in this community. METHODS: Qualitative study participants were recruited from community-based settings. Sex-specific focus groups were conducted by trained community health workers. Proceedings were audio-recorded for translation and transcription and coded using a constant comparative approach. Data were coded using Atlas.ti software. RESULTS: Six focus groups were completed with a final sample of 67 participants (63% male, 37% female). Mean participant age was 42 years; mean years of residence in the United States was 12. Key themes that emerged were beliefs about modesty and sex-separated facilities that may prevent women from engaging in physical activity. Distinctions were made between men and women about what constitutes exercise versus physical activity; religious prayer was considered to be health-promoting because of the movement involved. Other important themes that emerged were cultural dietary practices and evolving conceptions of healthy weight. CONCLUSION: Tailored interventions that take into account the cultural context of this growing community are needed. Findings may also provide insight into barriers to health promotion experienced by other US Muslim communities, which are growing rapidly.

Characteristics of Asian American, Native Hawaiian, and Pacific Islander community health worker programs: a systematic review.

Community health workers (CHWs) are frontline health workers who often serve socially and linguistically isolated populations, including Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities in the United States (U.S.) and U.S. territories. We conducted a systematic review of the peer-reviewed literature to assess the characteristics of CHW programs for AA and NHPI communities in the U.S. and U.S. territories, generating a total of 75 articles. Articles were coded using eight domains: ethnic group, health topic, geographic location, funding mechanism, type of analysis reported, prevention/management focus, CHW role, and CHW title. Articles describing results of an intervention or program evaluation, or cost-effectiveness analysis were further coded with seven domains: study design, intervention recruitment and delivery site, mode of intervention delivery, outcomes assessed, key findings, and positive impact. Results revealed gaps in the current literature and point towards recommendations for future CHW research, program, and policy efforts.

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.

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.