Alyson Myers, MD & Johanna Daily, MD, MS
“Developing Evidence Based Care for Diabetic Foot Ulcers at Montefiore Medical Center”
Yaguang Zheng, PhD, RN
“Hypoglycemia Detected by Continuous Glucose Monitoring Documented in Electronic Health Records”
Ryung S. Kim, PhD
“Prognostic Factors of Type 2 Diabetes among Patients with Gestational Diabetes Mellitus”
Andrea A. López-Cepero, PhD
“Chronic stress, negative eating behaviors, and glucose metabolism among US Latinx adults”
Nadia Laniado DDS, MPH, MS
“Point-of-care screening for dysglycemia in the dental clinic: a feasibility study at Jacobi Medical Center”
Developing Evidence Based Care for Diabetic Foot Ulcers at Montefiore Medical Center
The proposed research will address the management of diabetic foot ulcers (DFU), a common complication of diabetes that continues to be associated with high morbidity. We will assess the management and outcomes of in-patient admissions for diabetic foot ulcers in the Bronx, address the challenges of providers and Non-Hispanic Black and Hispanic/Latino patients to provide DFU care in the outpatient setting and test patient uptake/use of novel foot monitoring devices. The long-term goal is to develop an evidence-based practice standard, that integrates novel monitoring technologies to improve outcomes of DFU.
Hypoglycemia Detected by Continuous Glucose Monitoring Documented in Electronic Health Records
Hypoglycemia is a serious adverse event in type 1 diabetes (T1D) and insulin-treated type 2 diabetes (IT2D). Although hypoglycemia is well recognized in T1D, the risk has been historically underappreciated among individuals with IT2D. Recurrent hypoglycemia episodes lead to hypoglycemia unawareness (loss of neurogenic/autonomic warning symptoms) that increases the risk of severe hypoglycemia, which is associated with high morbidity and mortality. A major knowledge gap is the lack of evidence on accurate real-world rates of hypoglycemia among individuals with IT2D. Our current understanding of hypoglycemia relies on scanty point-of-care blood glucose monitoring or on clinical hypoglycemia recognition when a patient presents with symptoms; however, these fail to capture asymptomatic or nocturnal hypoglycemic episodes. One novel technology that can overcome these challenges is continuous glucose monitoring (CGM), which captures both asymptomatic and nocturnal hypoglycemic episodes. However, the true rates and risks of hypoglycemia captured by CGM in EHR remain unknown. Presently, CGM reports exist in the electronic health record (EHR) as PDFs that are not readily analyzable, thus, it calls for the scalable, efficient, and quick approaches (i.e., natural language processing (NLP)) to extract data from CGM reports. To fill the knowledge gap, we propose to use NLP to mine ambulatory patient CGM data in the EHR to determine the prevalence and risk factors including social determinants of health (SDoH) of hypoglycemia in IT2D. In Aim 1 we will use NLP to identify individuals with hypoglycemia detected by CGM. In Aim 2 we will determine the CGM-detected hypoglycemia burden (i.e., time spent in hypoglycemia, rates of level 1 and 2 hypoglycemia, frequency of hypoglycemic episodes) documented in the EHR for individuals with IT2D. In Aim 3 we will examine the association of demographics (i.e., age, sex, race/ethnicity), SDoH factors (e.g., poverty status, housing characteristics, and neighborhood), and clinical indices (i.e., type of CGM, medical conditions, medications, and HbA1c) with hypoglycemia burden detected by CGM in IT2D. The project will have important public health and clinical impact by objectively determining the prevalence of hypoglycemia detected by CGM in the EHR and examining its association with risk factors (e.g., SDoH). There are valuable CGM data in the EHR that could be used to identify patients at high risk of hypoglycemia. NLP is the key to unlocking the power in these data. The findings will provide preliminary hypoglycemia data extracted by NLP and establish feasibility for a subsequent NIH/NIDDK R01 (PA-19-056), building a tool to trigger providers which patients at risk of hypoglycemia using large-scale EHR data, at which point they can be incorporated into interventions to preventing severe hypoglycemia and reducing its high burden of morbidity and mortality.
Prognostic Factors of Type 2 Diabetes among Patients with Gestational Diabetes Mellitus
Gestational diabetes mellitus (GDM) affects up 10% of pregnancies in the US. In a recent study of a nationally representative sample of U.S. women, the prevalence of GDM was reported 7.6% among pregnant women, with 19.7% of these women having a subsequent diabetes diagnosis. Moreover, the incidence rates of GDM and lifetime type 2 diabetes (T2D) have been increasing. However, in-depth research on this progression is scarce, especially in identifying the key determinants of T2D incidence among women with GDM. A limited number of studies examined the predictors of T2D incidence among women with GDM, and they are mainly on demographic factor and SES. Even fewer studies have investigated the contribution of other pregnancy-related factors to the incidence of T2D.Major reason for the lack of literature on risk factors of T2D among GDM is the limited sample sizes in many studies: only1.5% of pregnant women are likely to develop GDM and subsequently T2D.To address these gaps, we propose to construct an electronic cohort of approximately 8,000patients with GDM from three sources, test associations between T2D incidence among patients with GDM with the key prognostic factors and build prognostic models for T2D incidence among patients with GDM. We hypothesize that increased sample size will yield statistical power to detect prognostic factors for T2Damongpatients with GDM. We aim 1)to construct a de-identified electronic cohort of GDM from three data sources: EMR in Montefiore Health System, EMR in Mount Sinai, and HCHS/SOL cohort, and to test the association between key predictors andT2Dincidence among patients with GDM,2) to build a prognostic model forT2Dincidence among patients with GDM by machine learning,and3)test whether race/ethnicity and social determinants such as health insurance and preferred language modify the association between the key factors and theT2Dincidence among patients with GDM. Our proposal assembles a highly qualified team of investigators to evaluate the feasibility and preliminary prognostic model of T2D among patients with GDM from two health provider networks and a large cohort study. To our knowledge, this cohort would be one of the largest cohorts of patients with GDM. Establishing a large cohort that can yield consistent estimators is a much-needed addition to the existing body of research. In addition, the findings of study of this subgroup with one the highestT2Dincidence rates will offer empirical evidence to aid the development of interventions to reduce the risk of T2D incidence among patients with GDM. If shown to be feasible in our pilot, this work will open an exciting new outlook and extramural funding opportunities for study of early intervention by an electronic prognostic tool as well as prospective observational studies to further identify risk factors and mediators of subsequent T2Ds.
Chronic stress, negative eating behaviors, and glucose metabolism among US Latinx adults
The overarching goal of this application to the New York CDTR Pilot and Feasibility Funds program is to generate knowledge on how stress and negative eating behaviors influence T2D and T2D risk in US Latinx. In addition, it will provide strong justification for an K01 grant application to use novel methods to identify specific daily stress-related contextual factors triggering negative eating behaviors and physiological responses in US Latinx adults. The proposed aims have been designed with a biopsychosocial lens that integrates social (chronic stress), behavioral (negative eating behaviors) and biological (physiological dysregulation) domains of influence on T2D disparities. The specific aims of this application were designed in response to the disproportionate burden of chronic stressors experienced by US Latinxs, their high risk of negative behavioral (i.e., eating behaviors) and physiological adaptations to stress, and the high prevalence of T2D. The proposed research aims are to: 1) examine the association between chronic stress and negative eating behaviors (i.e., intake of energy-dense foods and objective overeating); 2) evaluate the association between negative eating behaviors and CRP and adiposity markers at baseline and 6y; and 3) examine the individual and compound effect of negative eating behaviors and chronic stress on T2D at baseline and glucose markers (i.e., fasting glucose, HbA1c, and insulin resistance) at baseline and 6y. The proposed work leverages resources from HCHS/SOL for all aims. Approval from the HCHS/SOL committee has already been granted for Aim 1. This work will capitalize on the strong relationships of a research team comprised entirely of female Latinas, at different career stages, who have ample expertise in the fields of epidemiology, stress, T2D, eating behaviors, and Latinx health disparities. This project will significantly impact the field of T2D Latinx health disparities by bridging the gap in knowledge on stress, behavioral and physiological adaptations, and T2D in US Latinxs.
Point-of-care screening for dysglycemia in the dental clinic: a feasibility study at Jacobi Medical Center
The recognition that good oral health is essential for good overall health has driven increased efforts for interprofessional education and collaboration between medicine and dentistry throughout the United States (U.S.). For a chronic disease such as diabetes mellitus, in which there is an established bidirectional relationship with periodontal disease, oral health professionals are in a unique position to work with physicians and other providers to assist in identifying early stages of disease. The fact that many adults in the U.S. do not have a yearly medical visit but have routine dental appointments suggests that dentists can play a critical and often overlooked role in primary preventive measures such as point-of-care testing (POCT) for dysglycemia.
In the Bronx, the rates of diabetes and prediabetes are increasing and are higher than the national averages. This demands additional clinical settings to identify at-risk patients in the early stages in order to stem progression of disease and the onset of other co-morbidities. Point-of-care testing has been proven to be a quick, easy, and reliable method for monitoring dysglycemia in the primary care setting and has been incorporated into population health performance metrics for quality care. The American Dental Association has an in-office guide for monitoring and documenting hemoglobin A1c (HbA1c) levels which supports the point-of-care prediabetes identification tools co-developed by the Centers for Disease Control and Prevention, American Medical Association, and the American Diabetes Association. In accordance with these tools and recommendations, the primary aim of this study is to assess the feasibility of screening at-risk adult dental patients for abnormal blood glucose levels by means of a chairside finger-stick test in the dental clinic at Jacobi Medical Center. The second aim of this study is to identify adult patients’ attitudes toward blood glucose testing in the dental setting.
The results of this study will inform efforts to implement chairside diabetes testing in the dental clinics of New York City municipal hospitals as a public health primary prevention measure. If screening leads to early diabetes and prediabetes detection, prevention, and treatment, the dental clinics serving ethnically diverse underserved populations may prove to be an underutilized and critical venue in addressing the diabetes epidemic. Ultimately this project will set the groundwork for the development of a larger NIH-funded study which has the potential to alter current professional standards of care as it will focus on widespread implementation of chairside diabetes screening in dental care settings serving vulnerable populations. These increased efforts are especially relevant in light of the toll that COVID-19 has had on minority groups and those with comorbidities.
“Dynamics of Change in a Randomized Controlled Trial of Two Interventions for Type 1 Diabetes
Distress”
Diabetes distress (DD), defined as the negative emotional burden of living with a demanding
chronic
condition, is highly prevalent and has demonstrated stronger associations with important
diabetes outcomes
(e.g., HbA1c) than depression. Although psychological interventions for DD were developed
based on the
premise that reducing DD will improve clinical diabetes outcomes, empirical tests of these
treatments have
shown dramatic improvements in DD with little to no evidence for significant change in
HbA1c. Furthermore,
cognitive behavioral therapy (CBT) has not shown a clear advantage over diabetes
self-management education
and support (DSME/S; the current standard of care) in terms of DD reduction. This pattern of
findings
points to critical gaps in our understanding of the (a) causal pathways between DD and
clinical outcomes
and (b) the processes of change over the course of DD interventions. To address this gap,
the proposed
research will conduct the first intensive longitudinal assessment of causal links between
DD, diabetes
self-management, glycemic control, and purported treatment mechanisms over the course of two
DD
interventions, one novel and one established: ACT1VATE, a group-based Acceptance and
Commitment Therapy
approach, and DSME/S (usual care). A recent RCT (1R01DK127491; mPIs
Philis-Tsimikas/Fortmann) compares
ACT1VATE vs. DSME/S in improving glycemic control in N=484 diverse adults with poorly
controlled type 1
diabetes and significant DD. The proposed work builds upon this RCT to include a 7-week
period of
ecological momentary assessment (EMA) and continuous glucose monitoring (CGM) over the
course of both DD
treatments (n=50 per condition). By leveraging the resources of a well-timed R01, the
proposed study is
the first to investigate processes of change in symptoms, behaviors, and glycemic control
over the course
of two DD treatments. These data will be used to accomplish the following Specific Aims: 1)
Examine
trajectories of within-person change in daily DD, purported treatment mechanisms, diabetes
self-care
behavior, and CGM metrics over the course of DD treatment; 2) Examine these trajectories as
predictors of
HbA1c and global DD improvement 6 months later; 3) Explore relationships between
characteristics of change
in daily DD, purported treatment mechanisms, diabetes self-care behavior, and CGM metrics
over the course
of DD treatment. Results will inform potential common treatment ingredients, ideal targets
to optimize
treatment, and causal pathways linking DD, self-care, and glycemic control—all critical
steps toward
translation of RCT findings to the “real world.” The proposed work will be used as
foundational data from
which to build a novel, more effective, brief, optimized, targeted intervention for DD,
which will serve
as the basis of proposed PI Soriano’s subsequent submission of a larger, more definitive,
powered R01
application.
“Daily Assessment of Adherence to Diabetes Medication in the Einstein Aging Study (EAS)”
Diabetes and suboptimal glycemic control are common in older adults and are major risk
factors for
cognitive decline. To better measure glycemic control and assess its influence on cognitive
performance in
the recently renewed Einstein Aging Study (EAS) P01 type 2 diabetes (T2D) Project, we will
use ecological
momentary assessment (EMA) to link continuous glucose monitoring (CGM) to smartphone-based
measures of
ambulatory cognitive function. Though the funded Project includes daily self-report (SR)
measures of
medication adherence, it lacks objective and real-time measures of medication adherence. For
this pilot,
we propose to add electronic monitoring of adherence to oral medications using Medication
Event Monitoring
System (MEMS), and EMA assessment of real-time insulin adherence, in a sample of 60-75 older
adults with
T2D enrolled in the EAS. The addition of real-time assessment of medication adherence
provides
opportunities to study the bidirectional relationships of medication adherence and cognitive
function and
the adherence-mediated role of cognitive function on glycemic control in older adults with
T2D. In
addition, objective assessment of adherence will provide a unique opportunity to assess the
validity of SR
adherence already assessed in the EAS. Assessment of objective and real-time medication
adherence,
integrated with CGM and EMA, provides intensive longitudinal data for each participant
allowing for robust
modeling of within-person processes, which increases sensitivity and power and overcomes
measurement
limitations of prior research. In this pilot proposal, we plan to collect critical
feasibility and
acceptability data, power calculations, and perform preliminary analyses in older adults
with T2D for use
in a future K01 award application. In Aim 1, we will assess feasibility and acceptability of
adding MEMS
and EMA insulin adherence to EAS. In aim 2, we will examine whether day-level changes in
adherence
measured by MEMS are associated with changes in daily CGM metrics in older adults treated
for T2D with
oral meds. In Aim 3, we test cognitive and psychosocial predictors (depression/negative
affect and social
support) of MEMS adherence among older adults treated for T2D. In Aim 4, we will examine
whether cognitive
factors, age, and depression affect the strength of the association between MEMS adherence
and SR
adherence in those treated for T2D. The pairing of objective and real-time medication
adherence, glycemic
data, and ambulatory cognition is novel and an important area of study for the development
of effective
interventions.
“Feasibility of community-based digital tools to promote physical activity among Latinos with
diabetes”
We examine if a community-clinical integrated, real- time referral system (NCCare360) can be
leveraged to
refer patients to community-based physical activity programs. We apply a community-engaged
study design
involving patients, providers and community-based organizations (CBO’s) to examine
implementation factors
necessary to maximize the potential of community- clinical linkage systems to improve
health. Our Specific
Aims are to: 1) Characterize the range of social and structural determinants shaping
diabetes care and
physical activity adoption among Latinos and what they would like to see in a
community-based referral
system using survey and semi-structured data (n=50); 2) Adapt the existing referral system
specific to
Latinos using data from Aim 1 and pilot test the integration of physical activity referrals
into the
NCCARE360 system to determine acceptability, adoption, appropriateness, and feasibility of
integration.
The results from this study will be used to design a future intervention testing optimal
intervention
components for integrating health promotion programs in existing referral systems, uptake of
physical
activity among study participants, and resulting changes in diabetes outcomes.
“The role of neighborhood and household food environments and food shopping behaviors in
shaping diet
quality and glucose metabolism among Hispanic/Latino youth and their caregivers”
A large proportion of U.S. Hispanic/Latino adults (16.9%) have type 2 diabetes and U.S.
Hispanic/Latino
youth have prediabetes (22.5%), which is concerning as glycemic dysregulation increases
susceptibility to
additional poor cardiometabolic health outcomes. Simultaneously, U.S. Hispanic/Latino
households with
children are disproportionally affected by socioeconomic disparities, including household
food insecurity
(33.0% vs 14.0% national prevalence). Food-insecure households often perceive their
neighborhood food
environments to be poor and household members are more likely to have poor diet quality, a
risk factor for
prediabetes and type 2 diabetes. Yet, food shopping behaviors have the potential to
influence the types of
foods available in the homes of low-income Hispanic/Latino families, which could directly
influence
individual-level diet quality. Thus, multi-level, targeted evidence of these complex food
security-environment-shopping relationships is greatly needed in order to better understand
how to
intervene to promote healthy diet quality and glucose metabolism among the diverse heritages
that comprise
the U.S. Hispanic/Latino population. This research aims to use data from a cohort of
Hispanic/Latino
caregivers and youth, representative of diverse heritages, to (1) Identify latent food
security-environment-shopping classes based on similarities in household food security
status, the
perceived neighborhood food environment characteristics, and the type and frequency of food
outlet used
for food shopping among Hispanic/Latino families; (2) Determine the relationship of food
security-environment-shopping classes with the type of food available in the home and with
youth and
caregiver’s diet quality among Hispanic/Latino families; and (3) Determine the relationship
of food
security-environment-shopping classes with youth and caregiver’s glucose metabolism among
Hispanic/Latino
families. Data for all aims will be from the national Hispanic Community Health Study/Study
of Latinos-
Youth ancillary study, and findings will provide pilot data to develop a family-based type 2
diabetes
prevention intervention in Hispanics/Latinos.
“Emotional Distress in Type 1 Diabetes: The integration of Routine Psychosocial Screenings in
a
Real-World Endocrinology Clinic”
Diabetes distress (DD), defined as the negative emotional burden of living with a demanding
chronic
condition, is highly prevalent, and has demonstrated stronger associations with important
diabetes
outcomes than depression. In 2016, the American Diabetes Association (ADA) released its
inaugural Position
Statement on Psychosocial Care for People with Diabetes that details evidence-based
guidelines for DD
screening, and identifies diabetes self-management education and support (DSME/S) as the
first-line
intervention for people who screen positive for DD. Despite clear recommendations from the
ADA to screen
for DD as part of routine diabetes care, and the availability of brief, well-validated
measures to do so,
this guideline has not been translated into practice by most typical healthcare settings.
Further, little
is known about if or how DD affects an individual’s ability to access, engage with, and
derive clinical
benefits from DSME/S. While research is needed to determine how best to ameliorate DD, most
US health
systems have yet to accomplish the first necessary step, which is to integrate DD screenings
as part of
routine diabetes care. Thus, it is imperative to better understand the real-world barriers
and
facilitators of routine psychosocial screening in diabetes in Endocrinology -- i.e., where
the majority of
T1D is managed. The proposed feasibility pilot will directly address this gap by enlisting
diverse
stakeholders (patients, clinicians, clinic staff and leadership) to refine and pilot an
approach for
integrating routine DD screenings and referrals in the Scripps Division of Diabetes and
Endocrinology, in
San Diego, CA (Aim 1). Electronic health records (EHR) will be used to identify patients and
quantify
process outcomes (i.e., DD screening, and DSME/S referral and utilization rates; Aim 2a),
and improvements
in glycemic control and DD over 12 months (Aim 3a-c). Specific Aim 2b will elicit valuable,
post-implementation feedback from T1D patients and Scripps stakeholders on the feasibility
and
acceptability of the DD screening and referral processes. By developing and evaluating a
systematic
approach for identifying patients who are experiencing significant DD, this research will
guide US health
systems’ efforts to translate the ADA’s 2016 call for integrated psychosocial assessments in
diabetes into
practice. Further, by establishing this approach within a large, “real-world” Endocrinology
division, we
will maximize integration with routine care processes and capitalize on staffing and EHR
resources that
are commonly found in US healthcare settings, thus maximizing the generalizability of our
findings.
Finally, this study will provide important preliminary data for a larger, fully powered
randomized R01
trial to test a refined DD screening, referral, and intervention approach.
“Use of ecological momentary assessment tools in Type 1 diabetes”
Young adults (YA) with type 1 diabetes (T1D) of racial-ethnic minority and low socioeconomic
status are
amongst the most at risk for poor outcomes, with worse glycemic control, higher rates of
diabetes
complications, and premature mortality compared to non-disadvantaged peers. There remains a
paucity of
work examining and linking this population’s poor outcomes to their unique social,
biological, and
behavioral experiences, yet this information would be critical in identifying new and
potentially
modifiable targets for intervention. The Social Determinants of Health (SDH) model describes
“a set of
factors that affect the health of individuals and communities beyond personal choices that
are a product
of their life experiences, physical, social, and economic environments”. There is ample data
to suggest
that exposure to certain SDH can have negative health effects in disadvantaged populations.
Preliminary
work from Dr. Agarwal’s NIDDK-funded K23 award demonstrated for the first time, in a
national population
of disadvantaged YA with T1D, that SDH were highly prevalent and substantially predictive of
poor glycemic
control. However, this epidemiological work only provides a static snapshot of associations
among factors
and requires a deeper understanding of the dynamic nature of these relationships. No studies
have examined
the complex interplay between daily varying SDH, mood, stress, diabetes distress, diabetes
self-care, and
glycemia. In this pilot proposal, we plan to collect critical feasibility and acceptability
data as well
as perform preliminary analyses in disadvantaged YA with T1D for use in future larger R01
applications. In
Aim 1, we will test the feasibility and acceptability of several innovative data collection
methods to
capture dynamic daily behavioral and multi-level biologic data, including: 1) mobile
app-based ecological
momentary assessments (EMA); 2) salivary and hair cortisol testing; and 3) continuous
glucose monitoring
(CGM). In Aim 2, we plan to preliminarily explore SDH-self-care-glycemia relationships to
supply us with
sufficient information to form well-founded hypotheses and power analyses for future larger
grant
applications. The pairing of this dynamic detailed behavioral and glycemic data is highly
innovative and
has great advantage over studies using retrospective reporting of behavioral variables and
global measures
of glycemia. This work will be foundational in establishing data collection methods, finding
new ways of
measuring SDH, and exploring dynamic relationships from which we will gain new insight. This
work is
critical to advancing the field and identifying new targets for intervention.
“A Transition of Care Model from Hospital to Community for Hispanic/Latino Adult Patients
with Diabetes”
The prevalence of diabetes in adults over the age of 20 is significantly higher in the
Hispanic/Latino
population compared to non-Hispanic whites. Diabetes imposes a large economic burden as
individuals with
diabetes have significantly higher rates of hospital admission compared to those without
diabetes.
Moreover, admitted patients with diabetes are at higher risk for readmission and Emergency
Department (ED)
visits than those without diabetes especially those in lower socioeconomic status and
racial/ethnic
minority groups. Despite the economic burden and growing interest in factors leading to
readmission, a
paucity of research exists focusing on the transition of care among patients with diabetes.
The goals of
this proposed study are to: 1) explore patients and providers perceptions of the current
discharge process
which will inform the development of a patient-centered transition of care model for
Hispanic/Latino
adults (≥18 years of age) with diabetes from hospital to the community, and 2) pilot test
and determine
the feasibility of the transition of care model for Hispanic/Latino adult patients with
diabetes. A total
of 32, self-identified Hispanic/Latino adults admitted to local community hospital with a
diagnosis of
diabetes will be randomized using a 1:1 randomization to two arms: 1) usual transition of
care and 2) the
transition of care model. This pilot feasibility study will generate and provide valuable
data that will
serve as a strong foundation for a larger scale multicenter randomized controlled trial.
“Characterization of the personal networks of Latino adults to identify individual and
network-level
factors associated with T2DM”
The goal of this exploratory study is to examine how personal social networks of Latino
adults influence
their diabetes-related outcomes such as glycemic control and diabetes self-management. The
study will
first explore this by conducting a secondary analysis with existing HCHS/SOL data from the
Social Network
Index to evaluate the types of principal influencers of glycemic control among Latinos with
T2DM. Then,
the proposed study will employ a more nuanced approach to social network mapping to
disentangle the
positive and negative influences of social relationships in relation to risk and progression
of T2DM among
HCHS/SOL participants by collecting egocentric network data on a subsample of SOL
participants in New York
City (N=138). Findings from Aims 1 and 2 will inform an R01 application to develop and pilot
a social
network intervention with the most influential alters for T2DM-related health behaviors. The
proposed
study represents an important step in Dr. Flórez’s progress toward becoming an independent
New
Investigator and will advance the National Institutes of Health’s mission to increase
diversity in
health-related research.
“Feasibility of a Family-oriented mHealth Intervention for Chinese Americans with Type 2
Diabetes”
Chinese Americans are one of the fastest growing immigrant groups in the US, who suffer
disproportionately high type 2 diabetes (T2D) burden and have poorly controlled T2D. Given
the high
economic and societal burden of T2D and rapid population growth in Chinese Americans, there
is an urgent
need for research to develop effective interventions to address T2D burden in this
population. Recent
evidence suggests the importance of involving and empowering family members in diabetes
intervention and
calls for family intervention. A mobile health approach such as short message service (SMS)
might be a
promising way to deliver such family-oriented interventions to the target population given
prior studies
suggests that Chinese Americans often report challenges to attend in-person lifestyle
counseling because
of long working hours and lack of sick time from work. A SMS-based intervention provides the
flexibility
of allowing them to view the intervention at a time and place convenient to them. However,
such
intervention has not been developed for or tested in Chinese Americans with T2D. This study
will serve as
the first step to explore an alternative approach for managing T2D in this group. The goal
of this pilot
study is to examine the feasibility and acceptability of a family-oriented SMS intervention
in 30 Chinese
Americans with T2D and their family members. Participants will be randomized to one of 2
arms (n=15 each):
1) wait-list control and 2) SMS intervention. Both groups will continue to receive standard
of care
treatment for their T2D. The SMS group will receive brief lifestyle counseling videos via
SMS links. At
the end of the study, the wait-list control group will be provided the opportunity to
receive the
counseling videos. Measurements will be obtained at baseline, 3, and 6 months. The primary
outcome is
HbA1c and secondary outcomes include self-efficacy and diabetes self-management behaviors.
Findings from
this pilot study will inform a larger full-scale R01 efficacy trial of the SMS intervention,
and
ultimately, an implementation study in the real-world setting. This project can serve as a
program model
for other chronic disease interventions in Chinese Americans that require lifestyle
modification (e.g.,
prediabetes, hypertension), or for disparities research in other high-risk immigrant
populations (e.g.,
South Asians, Hispanic Americans).
“Food and drink advertisements and impact on obesity in urban environment”
Now that alcohol ads have been banned from transit, it is unknown what ads have taken their
place.
Relevant to obesity, replacement ads may be 'neutral' (e.g., for music, travel, technology),
possibly
beneficial e.g., promoting physical fitness), or detrimental (e.g., for candy, fast food,
soda).
Replacement ads (postpolicy) may have modified found associations (pre-policy) between
subway ads and
demographics, diet, and disease characteristics in surrounding communities. Relevant to
surrounding
communities, another consideration is what ads appear on streets adjacent to subway
stations. Adjacent ads
may have similarly high viewership (viewed by riders entering and exiting stations).
Moreover, adjacent
ads-though perhaps viewed more briefly-may serve as even stronger cues for impulse purchases
and
consumption, being even more proximate to sources of food/drink on city streets. The
proposed project will
assess ads for food/drink in, and around, subway stations. It will capitalize on the
alcohol-ad policy
change and use direct observation and secondary data. This study will serve as feasibility
work to
demonstrate: (a) capability for conducting longitudinal matched-pair research to assess for
change, and
(b) capability for assessing neighborhood food/drink ads as a component of local "food
environments".
Future grants, building on both Aims, will evaluate how local food environments relate to
obesity-related
conditions in patients: longitudinally, and including food/drink ads. The goal is to inform
policy change
(for food/drink: ads and sources) towards improved community health.
“Developing and Evaluating the T2DXcel Mobile Application for Adult Patients with Type 2
Diabetes”
Since 2014, our multidisciplinary team at Einstein and Montefiore has been developing and
evaluating an
innovative and personalized mobile application (the first mobile application that has been
developed and
evaluated at Einstein and Montefiore) for patients with asthma, which - like diabetes - has
a very high
prevalence in the Bronx. The ASTHMAXcel mobile application (available for tablets and
smartphones) has
been developed for adults and children. ASTHMAXcel is available on iOS and Android
platforms, and consists
of animated educational videos, personalized algorithms, push notifications, and games. Our
pilot study
with 72 adult patients demonstrated that ASTHMAXcel was associated with a high degree of
patient
satisfaction, time-efficiency, and significant post-intervention improvements in asthma
control,
asthma-related quality of life, and asthma knowledge. ASTHMAXcel was linked to significant
decreases in
asthma emergency department visits and hospitalizations. Given our team's experience in
establishing the
ASTHMAXcel application, and the need for similar personalizable and adaptive mobile
applications for
patients with diabetes, this proposal will develop, evaluate, and refine a patient-centered
mobile
application (T2DXcel), which will promote diabetes education and improve process and
diabetes-related
outcomes. By building upon our lessons learned in developing and evaluating the ASTHMAXcel
application,
through this current project, we will conduct a single-arm, proof of concept study and
recruit 50 adult
patients with type 2 diabetes (T2D) from outpatient primary and specialty care sites at
Montefiore.
“Cardiovascular Health in Emerging Adults with Type 1 Diabetes: Identifying Targets for Early
Intervention”
To assess the cardiovascular health of large populations, the American Heart Association has
defined the
concept of ideal cardiovascular health which includes seven indices: smoking, body mass
index, physical
activity, ucose, all of which are modifiable. Individuals with type 1 diabetes (T1D) are at
increased risk
of cardiovascular disease (CVD), but that risk can be significantly reduced through control
of traditional
CVD risk factors. Emerging adults with T1D (age 18-24) have often experienced poor diabetes
self-management and higher hemoglobin A1c. This is a time of change and exploration where
they are often
managing diabetes on their own. This includes attempts to minimize CVD risk. The purpose of
this pilot is
to describe the cardiovascular health of a sample of emerging adults with T1D, substituting
hemoglobin A1c
for fasting blood glucose. At the end of data collection, results of the assessment will be
shared with
each participant. We will then seek feedback about the barriers and facilitators to
achieving optimal
cardiovascular health. These pilot data will be used in the planning an R-level NIH/NIDDK
application to
test an intervention to improve cardiovascular health indices.
“Bringing the DPP to Geriatric Populations-BRIDGE”
The goal of this study is to test the feasibility of implementing Alive-PD, a telehealth
adaptation of
the DPP that is reimbursable through Medicare and other health insurers, in NYC senior
centers. Using NYC
senior centers as a recruitment base, we will enroll 30 adults over the age of 65 y to test
program
acceptability, changes in knowledge and behaviors, and changes in weight in a pre-post 12
month single-arm
trial. We hypothesize that program acceptability will be demonstrated by consistent program
use and an
attrition <30% over 6-months. The Alive-PD program will also lead to improved diet
quality and
increased physical activity, as measured by self-reported diet and physical activity and a
mean 5% weight
reduction. The proposed intervention has the potential to reduce health disparities in an
underserved,
high-risk population served by the nationwide congregate meals program, therefore yielding
considerable
public health benefits. This formative research will inform the development of an R01
application in
response to PAR-16-238 to test the effectiveness of an intervention within a multi-site
trial to reduce
risk of diabetes in older adults.
“B’N Fit Power: A School-Based Wellness Initiative for School-Age Children in the Bronx”
In this proposal, we aim to test a school-based intervention to promote resilience and
prevent obesity
related co-morbidities for impoverished racial/ethnic minority Bronx youth who are at
increased risk for
diabetes. B’N Fit POWER is a wellness program that integrates existing school wellness
promotion
activities, the Montefiore School Health Program (MSHP) – a network of
school-based health clinics, and
the Mosholu Montefiore Community Center (MMCC) – a network of afterschool programming, to
promote health
and build on the resilience of the adolescents. It offers culturally-relevant guidance
related to the
attainment of 7 Target Behaviors, namely to increase fruit, vegetable and sugar-free
beverage intake, obtain adequate sleep, daily physical activity, eating breakfast and lunch
daily, and
limiting fast food and unhealthy snacks. Although B’N Fit POWER targets youth with
overweight and obesity
and at high risk for diabetes, it is open to all middle school students at the school, via
community-led
recruitment efforts to reduce obesity-related stigma by promoting wellness and fitness. We
will conduct a
quasi-experimental trial of B’N Fit POWER and will compare students receiving B’N Fit POWER
(Group 1) to
two comparison groups: one from the same school receiving standard of care (Group 2) and, to
assess the
external validity of Group 2 in terms of characteristics and outcomes, an additional group
from another
school also receiving standard of care (Group 3). Effects of the program will be evaluated
using data
routinely collected at the schools (e.g. anthropometrics and labs from clinic and the school
Fitnessgram,
attendance, grades) and surveys. Multivariate logistic regressions and mixed-effects linear
models will
assess program effects for categorical or continuous outcomes and the RE-AIM approach will
identify
barriers and solutions to implementation.
“Gender Disparities in Recruitment and Placement in a Health System DPP”
The Diabetes Prevention Program (DPP) was a landmark lifestyle intervention demonstrating a
58% reduction
in risk of diabetes among adults with impaired glucose tolerance. Supporting the adaptation
of the DPP to
community-based settings is one of the core components of the national DPP agenda. There is
recognition
that targeted strategies are necessary to recruit eligible men for DPP given their low
participation in
DPPs nationwide (<20%) and their high risk for diabetes and related complications. The
goal of this P&F
proposal is to inform an R01 application to NIH in response to PA-16-428: Health Promotion
Among Racial
and Ethnic Minority Males (R01). This initiative is intended to: 1) enhance our
understanding of the
numerous factors (e.g., sociodemographic, community, societal, personal) influencing the
health promoting
behaviors of racial and ethnic minority males across the life cycle, and 2) encourage
applications
focusing on the development and testing of culturally and linguistically appropriate
health-promoting
interventions designed to reduce health disparities among racially and ethnically diverse
males age 18 and
older. Montefiore Health System (MHS) is a large integrated health system in the Bronx and
Hudson Valley
serving roughly 85% government payer (Medicaid and/or Medicare) patients of which
approximately 90% are
either Black or Hispanic. As of October 2016, 23% of patients referred to MDPP are male and
7.5% of
patients enrolled (i.e. attending 4 sessions or more) in MDPP are male. The proposed pilot
study will
provide preliminary data on the potential facilitators and barriers to participation among
men identified
through the Montefiore Diabetes Prevention Program (MDPP), a health system-based DPP.