Biostatistics Research

Efficacy of Two Novel Behavioral Post-cessation Weight Gain Intervention (Role: Coinvestigator; PI: RA Krukowski)
This three arm randomized trial proposes to compare weight stability versus weight loss, followed by a smoking cessation intervention, to determine their efficacy in reducing post-cessation weight gain.

Behavioral Weight Management for Pregnant and Postpartum Women in the Military (Role: Co-investigator; PI: RA Krukowski)
This three arm randomized trial proposed to use a Look AHEAD-modified weight management intervention to determine the extent to which gestational weight gain, postpartum weight loss or combination of the two contribute to weight management, health outcomes and readiness six months post-delivery in a cohort of military maternity care patients.

Strategies to Promote Cessation in Smokers Who Are Not Ready to Quit (Role: Coinvestigator; PI: R Klesges)
This four arm randomized trial will test a tobacco quit line for smokers not ready to quit, by comparing the brief advice with typical cessation resources to motivational interviewing, combined behavioral and pharmacologic rate reduction, and combined motivational interviewing and behavioral and pharmacologic rate reduction, in order to determine point prevalence and continuous abstinence at 6 and 12 months post interventions for each arm.

Identify Missing Heritability of Cardio-metabolic Phenotypes Using Longitudinal Studies (Role: Project leader)
The goal is to search the causal genes that associated with Cardio-metabolic Phenotypes in longitudinal studies using region-based methods. We will also develop new methods for region-based association testing of longitudinal phenotypes.

Pediatric Brain Tumor Consortium (Role: Site PI; PI: A Onar-Thomas)
The Pediatric Brain Tumor Consortium (PBTC), now in its 19th year, is composed of 11 academic centers and children’s hospitals located across the United States which are competitively selected based on their scientific excellence and clinical expertise in pediatric brain tumors. Within PBTC, we conduct clinical trials for pediatric brain tumors. The studies we design are generally Phase-I or Phase-II dose escalation trials or device trials, which also have biology, pathology, and neuroimaging aims.

Behavioral Weight Management Program in US AirForce (FitBlue Study) (Role: Coinvestigator;
PI: RA Krukowski)
The Fit Blue study tailors the evidence-based Look Ahead weight loss intervention, which has been validated in a civilian population, to the active duty military population, specifically the US AirForce. The program accommodates the lifestyle and environment
that is unique to military members. The study compares outcomes from two groups: one group receives a phone-based intensive counselor-directed weight loss intervention, while the other group receives a phone-based self-directed weight loss intervention. Fit Blue enrolled over 248 active duty military personnel stationed at Joint Base San Antonio – Lackland, and we are now at the stage of massive publication efforts from the study data.

CANDLE Study (Role: Coordinating Statistician, PI: F Tylavsky)
Conditions Affecting Neurocognitive Development and Learning in Early childhood (CANDLE) study recruited 1,503 pregnant women and their children and followed them for developmental profiles at Birth, 1-year, 2-year, 3-year, 4-year clinic visits as well as other home and phone visits between clinic visits. Currently, the study is scheduling visits for 8-9 years since birth of the CANDLE babies. My role with this study is to coordinate the data operations and statistical support aspects of the study, and help with the new grantproposals based on the available CANDLE data and sample inventory.

 

New, Emerging and Traditional Tobacco Use in the Military (Role: Site PI; PI: M Little)
The major goal of this study is to directly compare active duty personnel with National Guard/Reservists to gain greater knowledge about the frequency of non-daily use of traditional and new and emerging tobacco products. Also, to advance our understanding
of the prevalence, incidence and diversity of tobacco product use in this population which will improve scientific knowledge and inform FDA tobacco regulatory decisionmaking.

Prevention of Alcohol Related Incidents in the US Air Force (Role: Site PI; PI: R Klesges)
Alcohol misuse is a particular problem in the US Military. Fortunately, brief alcohol interventions (BAIs) for alcohol misuse have been validated as efficacious. Our groupbased BAI that we are conducting in the United States Air Force (USAF) Technical Training has resulted in a 54% reduction of Alcohol Related Incidents.

Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence (Role: Co-investigator; PI: I Graetz)
This study will fill the research gap by testing a web-enabled app designed with the explicit goal of improving long-term adjuvant endocrine therapy (AET) adherence. Patient-reported symptoms will be integrated directly with the patient’s electronic
health record in order to improve patient-provider communication about AET adherence and related adverse symptoms outside of clinic visits. The hypothesis is that monitoring symptoms and adherence with actionable alerts and tailored feedback reports to patients will result in timelier symptom management and higher long-term
adherence to AET.

Impact of Medicare Part D Coverage gap Closure on Health Outcomes (Role: Coinvestigator;
PI: C Kaplan)
This study will provide important information about how prescription cost-sharing affects healthcare utilization and health outcomes, as well as disparities in these important endpoints, and will provide important information to policy makers about
how to design insurance benefits and to lessen the consequences of poor adherence.

A Unified High Performance Web Service for Systems Genetics and Precision Medicine (Role: MPI; MPI: S Sen, RW Williams)
The project will enhance the GeneNetwork web service for genetic analysis of highdimensional omic data. It will (1) develop curation, quality control, and visualization tools for data, (2) develop computational tools for QTL mapping in complex crosses, (3) build a REST API to share data and software, and (4) develop new statistical and computational tools.

NIDA Core “Center of Excellence” in Transcriptomics, Systems Genetics and the Addictome (Role: Core leader; MPI: L Saba, RW Williams)
Genomic and computational support to NIDA research teams using rat models to study addiction. The project will support creation of open access tools for genomic and genetic analysis with a focus on rat research communities.

Systems Genetic Analysis of Multi-parent Crosses (Role: Site PI; MPI: GA Churchill, KW Broman)
To develop statistical methods and software for the analysis of multi-parental crosses such as the Diversity Outcross (DO) and the Collaborative Cross (CC). Special attention will be given to the development of mixed effects model for handling relatedness and to the analysis of high-dimensional phenotypes.

Improving the molecular diagnosis of drug resistant tuberculosis (Role: Site PI; MPI:M Kato-Maeda, A Cattamanchi)
This project seeks to identify the genetic contributors to multi-drug resistant strains of tubercolosis. Using deep sequencing, and a follow up association analysis, we will identify genetic loci that confer resistance. This will lead to more rapid and accurate
diagnosis and effective treatment of drug-resistant tuberculosis (TB). The findings will contribute to improved patient outcomes and reduce the spread of this deadly disease.

 

The Role of Adverse Symptoms and Clinical Response on Racial Disparity Outcomes in Breast Cancer (Role: Co-investigator; PI: I Graetz)
This study investigates whether black and white patients with hormone receptorpositive (HR+) breast cancer report adverse symptoms differently, contributing todiverse treatment decisions and ultimately disparities in health outcomes.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Transition
of Care in CKD (Role: Co-investigator; MPI: K Kalantar-Zadeh, CP Kovesdy, SJ Jacobsen)
The goal of this project is to examine how the best transition to dialysis treatment of kidney transplantation should happen in people who have very late-stage chronic kidney disease in order to have the best survival, fewer hospitalizations, and fewer costs.

Early Cooperative Group - Cross Study Project (Role: Co-investigator; PI: K Johnson)
Cross-study analysis of coordinated randomized clinical trials for weight management. Evaluation of the gained experiences in understanding efficacious intervention components in weight loss trials.

IND-Enabling Preclinical Development of a New Radiomitigator (Role: Coinvestigator; PI: G Tigyi)
This project will conduct IND-enabling drug development of a new small molecule radiomitigator based on the 2-((3-(1,3-dioxo-1H,3H-benzo[de]isoquinolin-2-yl)-alkylsulfamoyl]) benzoic acid (RP239) lead structure.

Improving Self-Care Decisions of Medically Underserved African-Americans with Uncontrolled Diabetes: Effectiveness of Patient-Driven Text Messaging versus Health Coaching (Role: Co-investigator; PI: J Bailey)

This is a pragmatic randomized clinical trial (the MODEL Study) to determine the comparative effectiveness of patient-driven test-messaging versus health coaching versus Enhanced Care for African-American adults with uncontrolled diabetes and multiple chronic conditions in medically underserved areas with an emphasis on identifying and quantifying important interactions between key baseline characteristics (1) rural vs. urban residence, 2) health literacy, 3) medical complexity, 4) social complexity, 5) smart vs. cell phone ownership, and 6) age) and treatment arm.

The Vitamin D-Gelsolin-S1P Axis in Rheumatoid Arthritis (Role: Co-investigator; PI: AE Postlethwaite)

This is a cross-sectional observational clinical study and a clinical trial. The crosssectional study will assess the association among serum levels of vitamin D (25(OH)D), gelsolin (pGSN), sphingosine 1-phosphate (S1P) in RA patients and develop clinical prediction models to predict selected markers and measurements of RA disease activity.

The objective of the clinical trial is to determine whether VitD replacement in humans with VitD deficiency/insufficiency will elevate levels of pGSN, reduce levels of S1P in plasma, and change lymphocyte expression of Sphk2.

MUC13 Mucin in Colorectal Cancer Health Disparity (Role: Co-investigator; PI: S
Chauhan)
To investigate association between differential/aberrant expression of MUC13 and/or MUC13 variants with colorectal cancer health disparity and its effect on malignant colorectal cancer cells phenotypes among AA/AI populations.

Targeted Nanotherapy for Pancreatic Cancer (Role: Co-investigator; PI: S Chauhan)
To develop an innovative targeted therapeutic and imaging approach for PanCa.

Finding Equitable and Effective MTM Eligibility Criteria (Role: Co-investigator; PI: J
Wang)
To address the issues of racial and ethnic disparities by finding equitable and effective MTM eligibility criteria.

The effect of a microprocessor prosthetic foot on function and quality of life in transtibial amputees who are limited community ambulators (Role: Co-investigator; PI: A Zucker-Levin)
To provide the most effective prescription for prosthetic devices to generate the best
patient outcomes for Veterans who have undergone limb amputation.

Pathobiology and Reversibility of Prediabetes in a Biracial Cohort (PROP-ABC). (Role: Co-investigator; PI: S Dagogo-Jack)
To follow the original cohort for additional 5 years, to obtain 10-year follow-up data on prediabetes events, and, most importantly, to determine whether early Lifestyle Intervention can reverse prediabetes in African Americans and Caucasians.

Role of Cytochrome P450 in Alcohol-mediated Effects on Antiretroviral and HIV-1 (Role: Co-investigator; PI: S Kumar)
To demonstrate that in monocytes/macrophages alcohol-mediated oxidative stress causes enhanced HIV-1 replication via pathways mediated through CYP2E1.