Neurodevelopment and Improving Children's Health Following EtS exposure (NICHES) +

Principal Investigator: Bernard Fuemmeler, Ph.D.

Funding Source: NIH / Duke University

Project Summary:

The overall goal of the Administrative Core is to provide infrastructure and oversight to maximize NICHES scientific success. The Director, Susan K, Murphy, Ph.D., the Center's Child Health Specialist, Scott Kollins, Ph.D., and the Program Administrator, Ms. Dale Montana will work together closely within the Administrative Core to coordinate Center operations. The investigators will be supported in this role by an External Advisory Committee (EAC) and by an Executive Committee (EC), which consists of the key investigators participating in the Community Outreach and Translation Core (COTC) and the Research Projects. The Administrative Core has the following specific aims: 1) foster and maintain communication among team members, with the EAC, with the NIEHS and EPA, and with other Children's Centers; 2) organize and integrate NICHES research, investigator training, and outreach activities to promote synergy and maximize the Center's impact on children's health in the community; 3) promote the training of experts in cross-disciplinary fields in children's environmental health; 4) manage fiscal and other resources; and 5) track NICHES outputs and outcomes to ensure timely progress towards Center goals.

Maternal Obesity, Child Executive Functions and Child Weight Gain +

Principal Investigator: Bernard Fuemmeler, Ph.D.

Funding Source: NIH / Duke University

Project Summary:

This project seeks to evaluate a model of childhood obesity that begins with maternal pre-pregnancy obesity as a distal risk factor contributing to the development of appetite dysregulation and poor executive functioning, increasing a child's risk for excess weight gain. The study will take advantage of a perinatal birth cohort with over 2000 births that has obtained prospectively collected data from the first trimester through infancy, inclusive of pre-pregnancy weight at the first prenatal visit, gestational weight gain, surveys regarding nutrition, stress and lifestyle behaviors, data from medical records on pregnancy and birth complications, maternal blood at the first trimester, and umbilical cord blood at delivery. The proposed study will recruit mother/child dyads from this cohort and conduct detailed assessments of IQ, executive functions (attention, inhibitory control, memory, affective-based decision making), appetite regulation using the eating in the absence of hunger laboratory paradigm, dietary intake, and anthropometric growth among 400 children at ages 4 years and two- years later at 6 years. Maternal blood specimens collected during the first trimester and cord blood at birth will be used to assay Interleuken-6 (IL-6) and monocyte chemoattractant protein 1 (MCP-1), two cytokines important in both metabolism and normal brain development. The primary hypothesis is that maternal obesity influences neurodevelopmental processes that regulate appetite and executive functions resulting in increased risk for obesity in offspring. A secondary/exploratory hypothesis is that markers of prenatal neuro-inflammatory processes mediate the effect of maternal obesity on adverse child outcomes. Conducting this study in the context of an established perinatal birth cohort provides a cost-effective opportunity to achieve our aims. The study will aid in disentangling the associations between maternal pre-pregnancy obesity, childhood appetite regulation, executive functions and child weight gain. By understanding how developmental factors shape individual differences that predict child obesity, it is possible to markedly improve prevention interventions by targeting key risk factors for childhood obesity at earlier developmental periods and create tailored prevention programs that shift children's weight trajectory toward more healthy outcomes.

 

Effects of cigar flavors on measures of abuse liability among young adults +

Principal Investigator: Andrew J. Barnes, Ph.D.

Funding Source: National Institutes on Drug Abuse

Project Summary:

Tobacco use contributes to nearly half a million deaths in the United States annually. To reduce this death toll, the Food and Drug Administration (FDA) was granted regulatory authority over tobacco in 2009. This authority was limited with respect to cigars, which are increasingly popular. In 2014, FDA proposed broader regulatory control over these products, including flavored cigars. The availability of cigar flavors, among other characteristics, has been linked to increased sales and consumption, with the largest increases among youth/young adults and certain racial/ethnic minorities. No studies exist quantifying the effect of cigar flavors on abuse liability—the degree to which a psychoactive drug or formulation would be used for nonmedical purposes and that abuse would lead to dependence. Such evidence is essential to reducing cigar smoking among youth/young adults, who have a high risk of experimentation and relevance to FDA priorities. The current study aims to address this critical evidence gap by systematically examining the effect of four flavors of Black & Mild (B&M), the most popular cigar brand, on three measures of abuse liability in young adult conventional tobacco cigarette (CTC) smokers: 1) exposure to nicotine via saliva concentrations; 2) breakpoint from behavioral tasks where individuals choose between money or cigar puffs; 3) and subjective measures of cigar effects. Current CTC smokers (N=25; aged 18-21 years), who are inexperienced cigar smokers (≤5 times), will complete 5 Latin-square ordered, within-subject laboratory conditions that differ by product smoked: own brand CTC or B&M cigars in original, apple, cream, or wine flavor. The proposed study closely aligns with FDA-CTP priorities articulated in RFA-OD-15-004 including cigar initiation, use (and multiple use), perceptions, dependence and toxicity and the impact of tobacco product characteristics on initiation among populations most at-risk for flavored tobacco use. Results from this work will inform the impending regulation of cigars specifically as well as provide a method that can be used to evaluate the influence of flavors in other tobacco products. We will leverage the evidence base established from this research into a R01 proposal to test a broad spectrum of policies to regulate tobacco product flavors.

Delivering High-Quality HIV Care in the South: System-Level Policy Alternatives +

Principal Investigator: April D. Kimmel, Ph.D.

Funding Source: National Institute on Minority Health and Health Disparities

Project Summary:

While clinical care for HIV has made tremendous advances, the majority of persons living with HIV in the US do not receive the evidence-based care that will allow them to fully extend life and improve health. Lack of effective HIV care is particularly problematic in the Southern region, the epicenter of the US HIV epidemic and where poverty, uninsurance, rurality, and a constrained health workforce further threaten effective care. Research suggests that system-level factors, or the structural and policy-related aspects of health care delivery, have the potential to improve quality of care and health outcomes. But little is known about their role in the context of HIV care delivery, quality of care, and health outcomes. The proposed research will study how two modifiable system-level factors—geographic accessibility to care and physician payment policies—affect quality of HIV care and population outcomes, including new HIV infections, along the HIV care continuum in the US South. Because racial and ethnic minorities face increased barriers to HIV care, we pay special attention to how these system-level factors may contribute to disparities in quality of HIV care and population outcomes along the HIV care continuum. The research involves developing a novel database that combines multiple data sources, including Medicaid administrative claims files, HIV surveillance data, and county and state characteristics from national datasets. Our approach will rely on state-of-the-art spatial network analysis and data visualization (mapping), statistical tests using econometric methods, and systems science forecasting techniques that have been used to study quality of care and population health outcomes. The work moves beyond examination of core quality of HIV care measures to include HIV-related preventive care measures that collectively are critical to reducing HIV morbidity and mortality. In investigating these factors, the study will answer a number of important questions. How do geographic accessibility, measured in travel time to receive care, and physician payment for services affect quality of HIV care in the South? Are these effects different among racial and ethnic minorities? Do improvements in geographic accessibility or increased physician payments reduce new HIV infections and racial and ethnic disparities along the HIV care continuum? The proposed study will address these questions and others. By quantifying the role of system-level factors in quality of HIV care and population health along the HIV care continuum, as well as understanding disparities in these effects, the research will provide valuable information to state and federal policy makers who seek to address systemic challenges to effective HIV care, efficiently allocate scarce resources, and improve public health.

Central Africa International Epidemiologic Database to Evaluate AIDS (IeDEA) +

Site Principal Investigator: April D. Kimmel, Ph.D.

Funding Source: National Institutes of Health: National Cancer Institute, National Institute of Allergy and Infectious Diseases, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and National Institute on Drug Abuse.

Project Summary:

Elimination of HIV infection as a cause of human illness and death, and achieving "zero HIV transmission" have been embraced by the AIDS research and treatment communities as achievable. As HIV care and treatment programs are implemented throughout Africa, critical advances in research and policy are needed, so that care and treatment resources can be deployed to optimal benefit: decreasing both new HIV transmissions and HIV-related morbidity and mortality. Among the most important challenges to maximizing the public health benefits of HIV care and treatment programs are late diagnosis of HIV-infection, low rates of linkage to care, and high rates of late ART initiation which in turn ar associated with high rates of mortality, more costly clinical management and continued HIV transmission. In addition there remain unanswered clinical questions for persons living with HIV (PLWH) even with optimal ART. For PLWH in SubSaharan Africa (SSA), ART has been highly effective in decreasing HIV-related morbidity (and mortality), but the association of HIV with metabolic diseases and other conditions of aging (e.g. cancers), and the impact of under- or over-nutrition are not well defined. Newly funded as CA-IeDEA four years ago, we have built a new Central Africa IeDEA (CA- IeDEA), and have 1.) Compiled and managed secondary source patient-level data on ~52,000 patients through both extraction from existing electronic data and new on-the-ground systems for efficient capture of clinical data in low-resource clinical settings; 2.) Been highly productive scientifically with >20 publications even while data collection was in development, and 3.) have continued to foster African leadership and build local research capacity. We propose now to increase the database modestly (to ~80,000 patients) to increase the representativeness of HIV in the region geographically and in service delivery strategies and success and to expand our implementation science approaches to optimize short- and long-term HIV care outcomes both in Central Africa and globally, continue to investigate epidemiologic questions with clinical impact, with a focus on the comorbidities of aging and women's reproductive health.

Disparities in Cancer Screening: The Role of Medicaid Policy +

Site Principal Investigator: Bassam A. Dahman, Ph.D.

Funding Source: National Cancer Institute and the Office of Behavioral and Social Science Research / University of Pittsburgh

Background

There are substantial disparities in breast and cervical cancer diagnosis, treatment and outcomes in the U.S. by race, ethnicity, socio-economic and insurance status. While mortality rates have fallen over recent decades due to improved screening and treatment, these benefits are not distributed equally across the population.

Despite the existence of programs aimed at screening underserved women (e.g., the National Breast and Cervical Cancer Early Detection Program), many eligible women are not reached, and research shows that significant disparities in screening remain. Medicaid coverage for low-income women may play an important role in ensuring access to screening, though supporting evidence is limited and does not address recently enacted and proposed changes in patient eligibility, physician payment and patient cost sharing.

Study design

The study examines how existing and new policies that affect the generosity of state Medicaid programs correlate with breast and cervical cancer screening and related health outcomes among low-income women. The study will consider the effect of pre- and post-healthcare reform variation in eligibility between and within states, as well as the effect of physician payment and patient cost sharing on screening. It will also assess how the variation in Medicaid generosity across states and over time is related to outcomes including cancer incidence and stage at diagnosis.

The project brings together complementary secondary data from a number of sources. Nationally representative survey data from the Behavioral Risk Factor Surveillance System will be used to study the effects of Medicaid eligibility on breast and cervical cancer screening among low-income populations.

Medicaid administrative claims and utilization data will allow us to consider the effects of changes in eligibility as well as physician payment and patient cost sharing on screening among Medicaid enrollees. Surveillance, epidemiology and end-results cancer registry data will be used to estimate the effects of changes in Medicaid generosity on cancer incidence and stage at diagnosis.

Intended policy outcomes

Findings from this study will provide evidence about the impact of public policies on cancer screening for underserved populations. The study will be the first to explore the effects of recent Medicaid policies on breast and cervical cancer screening and diagnosis among low-income women. The outcomes considered will also serve as an indicator of the effect of health reform on prevention and women’s health.

Prevention of Weight Gain in Young Adults +

Co-Investigator: Jessica LaRose, Ph.D.

Funding Source: National Institutes of Health / National Heart, Lung, and Blood Institute

This is a multi-site randomized controlled trial testing two innovative interventions to prevent weight gain compared to a control condition over an average 3 years of follow-up in individuals 18 to 35 years of age.

Petersburg Wellness Engagement Project +

Principal Investigator: Maghboeba Mosavel, Ph.D.

Funding Source: National Institute on Minority Health and Health Disparities

The goal of this research is to assess: 1) The strengths and resources critical for addressing obesity, 2) The social-cultural perceptions of obesity, and 3) The family-based, community-wide interventions that can be supported citywide to increase physical fitness and improve nutritional choices. Specific aims include conducting a needs assessment informed by community input from multiple sources, and developing and implementing a pilot intervention that will address individual, family, community and societal factors to galvanize the community to increase physical activity and improve nutritional choices and options that will reduce obesity.

Categorization and Effects of e-cigarette Advertising Themes on Tobacco-related Attitudes, Intentions, and Behavior among Youth +

Researchers: Andrew J. Barnes, Ph.D. and Caroline Cobb, Ph.D.

Funding Source:  Virginia Foundation for Healthy Youth

Electronic cigarettes, or e-cigarettes (ECs), are novel products marketed as a means for tobacco smokers to self-administer nicotine without most other tobacco toxicants. Already, 14% of the adult US population has used an EC. More worrying are the increases in youth prevalence.  A national study from December 2014 found 17% of 12th graders had used an EC in the past month (compared to 14% for cigarettes), 16% for 10th graders (vs. 7%), and 9% among 8th graders (vs. 4%).

ECs are currently unregulated at the federal level and in Virginia the only EC-related policies prohibit their sale minors and on school property. Unlike cigarettes, which have strict restrictions on advertising to youth, ECs can be marketed to youth through television, radio, magazines, and other media channels, which likely increases their appeal to this vulnerable population.

Given the evolving nature of the EC market, it is important to understand the advertising messages being put forth by the industry as well as their impact on EC attitudes, intentions, and abuse liability measures. This is particularly critical for youth, who are known to be more susceptible to advertising, and are a group of central interest to state and federal lawmakers currently considering legislation on EC advertising and the Virginia Foundation for Healthy Youth (VFHY).  

In the current study, we will 1) qualitatively categorize current EC advertising messages into thematic categories, (e.g. themes of reduced harm compared to cigarettes, use as a cessation device, sociability, or freedom from smoking bans), 2) experimentally evaluate the receptivity of a sample of Virginia youth, 13-18 years of age (n=1,400), to the most dominant three EC advertising themes identified, and 3) compare the effects of EC message receptivity between current cigarette smokers and susceptible non-smoking youth.

Using a between-subjects design, participants will be randomized to a control condition or one of the three EC thematic conditions. Each condition will involve an EC advertising exposure and questionnaire-delivered measures. Receptivity outcomes include EC-related attitudes, intentions to use ECs, and measures of EC abuse liability using a behavioral economics-based approach (i.e., cigarette purchasing task).

Investigating Effects of Regulating E-Cigarette Flavoring and Modified Risk Messages on Measures of Abuse Liability +

Researchers: Andrew J. Barnes, Ph.D., Caroline Cobb, Ph.D. and Thomas Eissenberg, Ph.D.

Funding Source: Massey Cancer Center Pilot Program and the CCTR Endowment Fund

Background

Tobacco use is the leading cause of preventable death worldwide and accounts for more than 480,000 deaths in the United States (US) annually. While adult smoking prevalence stagnates in the United States, new noncombustible tobacco products like electronic cigarettes (ECs) are gaining popularity. ECs are marketed as a means for tobacco smokers to self-administer nicotine without most other tobacco toxicants. An EC consists of an electric power supply (usually a battery), a heating element, and a liquid that includes propylene glycol and/or glycerin, flavorants and, usually, nicotine. ECs are currently unregulated at the federal level. In April 2014, the US Food and Drug Administration’s (FDA) Center on Tobacco Products proposed that ECs be subject to FDA regulation. The FDA’s proposal, among other things, highlighted interest in evidence to inform the regulation of EC liquid flavors and requiring approval for modified risk descriptors insinuating lower harm potential (e.g. “light,” “mild”). However, the extent to which federal oversight of EC liquid flavors and modified risk messages will affect EC use among Americans is uncertain, as is the influence of EC regulation upon combustible tobacco cigarette (CTC) use.

Study Design

This study will examine how the likelihood of abuse, or “abuse liability”, of ECs varies by EC liquid flavorings, the presence of a modified risk message, and compared to CTCs. This study will be performed among a sample of regular CTC smokers, naïve to EC, using a within subjects design: EC liquid flavor by message. Own brand CTC abuse liability will be assessed at baseline.

Intended Policy Outcomes

The evidence base established from this pilot research will be leveraged into additional funding to build and test a comprehensive set of experiments to fully characterize the effects of a broad spectrum of federal and state policies to regulate EC consumption.

Low Intensity Weight Loss for Young Adults: Autonomous vs. Extrinsic Motivation +

Principal Investigator: Jessica LaRose, Ph.D.

Funding Source: National Institutes of Health

Forty percent of 18-25 year olds are overweight or obese, yet this population is markedly underrepresented in behavioral weight loss (BWL) programs, and to date, no programs exist that specifically target this group for weight loss. The proposed study will test the relative efficacy of two novel, low intensity weight loss programs designed to enhance motivation in this age group and a standard web program; all arms will be compared on initial weight loss and maintenance of weight loss following a 6-month no-treatment contact period. If efficacious, the proposed programs have potential for dissemination and could have profound public health impact by decreasing the financial and health costs associated with obesity as this generation ages. 

Preventing and Controlling Obesity and Chronic Disease through Evidence-Based Programming +

Principal Investigator: Jessica LaRose, Ph.D.

Funding Source: Virginia Department of Health, Richmond City Health District

The goal of this initiative is to implement environmental and school-based strategies to improve nutrition access, dietary choices and reduce obesity risk among children in Richmond Public Schools. A central goal of this work involves a systematic evaluation of these efforts to determine the impact on key outcomes of interest.

Improving Adolescent Obesity Treatment: Exploring the Role of Parents +

Co-Investigator: Jessica LaRose, Ph.D.

Funding Source: National Institutes of Health

There is an urgent need for innovative approaches to obesity prevention and treatment, particularly among African Americans (AA), a population at increased risk of obesity and its associated morbidity and mortality. Research and clinical practice guidelines consistently recommend that parents should be included in their children’s obesity treatment, yet the most effective strategy to engage parents in adolescent obesity treatment is unclear. The adolescent period presents substantial challenges to family-based care, as youth experience increased desire for independence and autonomy, contributing to resistance to authority figures; yet they still rely on parents for many needs. Given these challenges, it is not surprising that research investigating specific clinical paradigms for involving parents in adolescent obesity treatments is inconsistent. To that end, the current application pilots two distinct approaches for involving parents in their adolescents’ obesity treatment. TEENS (Teaching, Encouragement, Exercise, Nutrition, Support) is a family-based, multidisciplinary behavioral treatment program targeting primarily AA, obese adolescents. This investigative team previously demonstrated that participation in the TEENS intervention is associated with significant reductions in body mass index (BMI) at 6 months. In TEENS, parents were included in monthly groups to support their adolescent’s weight management. Although parent weight was not targeted, a significant correlation between parent and adolescent BMI change was found. These findings highlight the importance of parental involvement and suggest that parent weight management might be an important intervention target. Indeed, directly targeting parent weight loss within adolescent treatment might be associated with even greater adolescent BMI reductions, as parents engaged in concurrent weight management might make greater changes to the shared environment and serve as powerful role models, given their common goals. Towards that end and building on our previous work, we developed TEENS+, a family-based adolescent obesity intervention. This application proposes a randomized controlled pilot to determine the feasibility and preliminary efficacy of two parent treatments within TEENS+ among 96 overweight or obese adolescents (BMI>85th percentile) and parent(s) (BMI>25 kg/m2). Families will be randomized to one of two 4-month treatments: 1) TEENS+Parents as Coaches (PAC), engaging parents as helpers in their child’s weight management, or 2) TEENS+Parent Weight Loss (PWL), engaging parents in their own weight management. All adolescents will participate in the TEENS+ protocol, which includes nutrition education with dietary goals, supervised physical activity, and behavioral support, and integrates motivational interviewing to enhance treatment engagement. Assessments will be completed at 0, 4, and 7 months. Results of this investigation will inform a subsequent larger trial investigating the role of parents in adolescent obesity treatment, targeting predominately African American families. 

Red Flag Campaign Outcome Evaluation +

Co-Director of Research and Evaluation: Kellie E. Carlyle, Ph.D., M.P.H.

Funding Source: Community-Engagement Grant and Avon Foundation

Summary: http://www.ivpp.vcu.edu/programs/empower/index.html