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Current Projects

Principal Investigator: Cheryl Woods Giscombe, PhD, RN, PMHNP-BC, FAAN

Funded by: National Institute on Minority Health and Health Disparities (NIMHD)

Abstract: African American women (AAW) have higher rates of death and disability from chronic cardiometabolic (CM) illnesses compared to any other group of women in the US, including diabetes, cardiovascular disease, and stroke. 80% of AAW are overweight or obese, and they are the largest US sociodemographic group with inadequate engagement in exercise. Nearly 50% of AAW have cardiovascular disease, and AAW have more than twice the rate of diabetes compared to White women. Compelling evidence shows that AAW are least successful at achieving and sustaining CM risk-reduction goals compared to men and women of other racial/ethnic groups, despite participating in comprehensive lifestyle interventions. These alarming disparities are due in part to disproportionately high rates of exposure to psychological stress. Culturally-relevant stressors in AAW are positively and significantly associated with perceived stress, depressive symptoms, unhealthy eating, and physical inactivity in AAW – CM risk factors. A shortcoming of interventions with AAW is their inadequate focus on stress exposure, including gender and racialized stress, stress physiology and stress- related barriers to healthy eating and exercise known to reduce CM risk. To address this shortcoming, we propose a randomized controlled trial to test a culturally-tailored mindfulness-based stress management intervention. This RCT is designed to help AAW build on their strengths to promote stress management and improved CM health by enhancing positive reappraisal, self-regulation, and self-efficacy, all of which are cognitive-behavioral facilitators of self-management and positively impacted by mindfulness training. In this 2- arm CM-risk reduction RCT with 200 AAW ≥ 18 years old with CM risk, we will be powered to detect group differences in exercise and healthy eating behaviors Specific aims are: AIM 1: Test the hypothesis that AAW participating in an 8-session culturally-relevant mindfulness-based intervention to reduce CM risk have: AIM 1A (primary) greater sustained improvements in exercise and healthy eating behaviors and AIM 1B (secondary) greater reduction in CM risk biomarkers (BMI, % body fat, waist to hip ratio [WHR], BP, and inflammatory cytokines [High Sensitivity C-Reactive Protein; hs-CRP])) at 4, 8, and 12 months, compared to AAW in an attention-control CM risk reduction intervention without mindfulness. AIM 2 (exploratory: Test the hypothesis that improvements in mindfulness, stress management, positive reappraisal, self-regulation, and self-efficacy mediate the effects of the intervention on exercise and healthy eating. We will work with a community health agency and a community advisory board to facilitate the implementation and success of our intervention. We address the NIH call to identify interventions that promote self-management to reduce disparities through a culturally-tailored, community-based mindfulness-based intervention for AAW that targets resilience in the face of culturally-relevant stressors. If effective, we will scale this contextually relevant mindfulness intervention based on AAW’s strengths for broad use in community settings.

Principal Investigator: Shawn M. Kneipp, PhD, RN, ANP, PHNA-BC, FAANP

Funded by: National Institute on Minority Health and Health Disparities (NIMHD)

Abstract: The overall goal of this study is to adapt and test the effectiveness of a multilevel intervention to reduce chronic disease risks in socioeconomically disadvantaged, unemployed populations that can be readily adopted by communities. Studies have shown that an unemployment episode exacerbates engaging in health-compromising behaviors, psychological distress, accelerated weight gain, and higher blood pressure – all of which increase chronic disease risk. Although socioeconomically disadvantaged adults often receive public assistance benefits, job training, and job placement services through Department of Social Services Employment (DSS-E) programs if job loss occurs; these programs do not include prevention-focused content to reduce the chronic disease risks that accrue with unemployment episodes. In addition, DSS-E efforts to help individuals succeed in securing and performing in a new job are often thwarted by implicit ‘welfare’-related bias and insufficient job supports in the work environments that DSS-E clients are hired into. We will use a randomized, 2 x 2 factorial design to test interventions at each of two levels (individual, and employer), and their joint effects, in DSS-E clients and employers that hire this population. In Year 1, we will make minor adaptations to existing interventions at each level to ensure they are contextually relevant to the unemployment, and job-entry experiences of DSS-E populations. At the individual level, 600 DSS-E clients will be randomly assigned to a group that receives usual DSS-E in addition to a Chronic Disease Prevention Program (CDPP) that includes online instruction and individual lifestyle coaching sessions, or a group that receives usual DSS-E services only. At the employer level, between 50-80 employers will be allocated to an intervention or control arm using an adaptive, biased-coin randomization approach to ensure balance across the four treatment conditions. The employer intervention combines implicit bias awareness training for supervisors of hired DSS-E clients, and regular, structured, interactions between supervisors and DSS-E hires. The interventions at each level are designed to mitigate the psychological, behavioral, and clinically relevant risks for chronic disease onset, morbidity, and comorbidity that accrue with unemployment and structural factors in the workplace that can exacerbate these risks. This proposed research builds on the strengths of long-standing academic-community partnerships between the research team and key stakeholders across health, social service, employment, and economic development sectors. The findings from this study will advance the science of chronic disease prevention for this vulnerable target population, and will inform national public health efforts to address social determinants of health and reduce chronic disease burden at the community level.

Principal Investigator: Anna Beeber, PhD, RN, FAAN

Funded by: Agency for Healthcare Research and Quality (AHRQ)

Abstract: Assisted living (AL), an alternative to nursing homes, provides housing, meals, 24-hour supervision, and, in some cases, health and supportive services. Unlike other healthcare settings, AL uses a social rather than medical model of care emphasizing a person-centered approach. However, while AL strives for person-centered care, resident acuity has been rising (e.g., functional decline; dementia), creating tension between supporting autonomy and minimizing risks from medication errors, infections, falls, and in cases of dementia, elopement and injuries. Similarly, the focus on person-centered practices (e.g., aging in place, well-being, quality of life) can be at odds with safety risks such as injury, elopement, or worsening chronic conditions. Discrepancies between the goals of residents/family and AL staff may result in disagreements, dissatisfaction with care, unnecessary treatments or hospital transfers. Thus, the core challenge of AL care lies in balancing person-centeredness with safety risks. A highly promising method for achieving this balance is person and family engagement (PFE). PFE refers to the person and family’s desire, ability, and activation as a partner with an individual (e.g., staff or healthcare provider), team, and/or setting to maximize outcomes and experience of care. Although PFE research is beginning to address non-hospital settings such as primary care and nursing homes, very little has been conducted in AL settings. Given the uniqueness of AL, one cannot assume that the approaches applicable to hospitals will directly apply to AL; therefore, in the proposed research, we will explore how to translate and adapt existing PFE work to the AL setting and develop a comprehensive toolkit to increase PFE in AL safety. Through a stakeholder-engaged, mixed methods study we will complete the following aims: AIM 1: Identify common AL safety problems. We will use structured interviews and surveys to identify AL safety problems (including how safety risks are balanced with person-centered care factors) and determining strategies to increase PFE in AL from the perspectives of: a) AL residents and family caregivers; and b) professional stakeholders; AIM 2: Rank AL safety problems and evaluate existing PFE interventions, tools, and strategies applied to other healthcare settings for their fit with AL. We will first do a web-based Delphi panel with a stakeholder panel to rank the AL safety problems and reconcile differences across stakeholder type. Our study team will then evaluate PFE interventions and tools that may apply to AL. The stakeholder panel will then reconvene to review these strategies and evaluate the fit with AL; and AIM 3: Develop a testable toolkit to improve PFE in AL safety. Using web-based focus groups with the AL stakeholder panel from Aim 2, we will match the ranked AL safety problems with the most promising PFE strategies (from Aim 2), identify new PFE strategies for AL safety, and identify and create essential components of the toolkit.

Principle Investigator: Diane Berry, PhD, RN

Funded by: National Institute for Nursing Research (2018-2019)

Abstract: Hispanic women and children who become overweight or obese are at risk for developing prediabetes, type 2 diabetes, and cardiovascular disease later in life. To date, there have been no interdisciplinary interventions that have targeted Hispanic women and their 4-year old children to improve nutrition and physical activity behaviors to manage adiposity and weight in mothers and prevent excessive adiposity and weight gain trajectory in their children. Using a randomized two-group, repeated measures experimental design, the goal of the proposed study is to investigate the efficacy of a 12-week nutrition and exercise education, physical activity, coping skills training, and home-based physical activity intervention in Hispanic women and their 4-year old children and 6 months of continued monthly contact to help overweight and obese Hispanic mothers improve adiposity, weight, health behaviors (nutrition and physical activity), and self-efficacy and their 4-year old children improve their adiposity and weight gain trajectory and health behaviors (nutrition and physical activity). W e will partner with two federally qualified health departments in Durham and Chatham, North Carolina to enroll Hispanic women and their 4-year old children and we will partner with community centers to deliver the intervention. A total of 294 Hispanic women with a BMI 2 >25 kg/m and 294 Hispanic 4-year old children with a BMI percentile > 25 will be enrolled over 4 years and randomized to the experimental or equal attention control group. Data will be collected at Time 1 (0 months [baseline]) to Time 2 (9 months [completion of the intervention]) and Time 1 to Time 3 (15 months [after 6 months with no contact from the study staff]). Data collected will include adiposity (primary outcomes: waist circumference, triceps and subscapular skinfolds) in mothers and children and weight (primary outcomes: body mass index [BMI] in mothers and BMI percentile in the children). Secondary outcomes will include health behaviors and self-efficacy in the mothers (Adult Health Behavior Questionnaire, Lifestyle Health Promoting Profile II, 3 day 24-Hour Food Recall, and 7 day Accelerometer, Eating Self-Efficacy Scale and Exercise Self-Efficacy Scale) and in the children (7 day Accelerometer and 3 day 24-Hour Food Recall). We will also evaluate the cost of delivering the program for public health departments. Data analysis will use general linear mixed models to test the hypotheses. Decreasing overweight and obesity in Hispanic women and slowing adiposity and weight gain trajectory in young Hispanic children is urgently needed to decrease morbidity, mortality, and future health care costs. The knowledge to be gained from this study may provide a foundation for extending this intervention to other Hispanic mothers and children in other communities to assist mothers in managing their weight and preventing excessive adiposity and weight gain in their children. This approach is translatable, real-world, and could be replicated in other areas of the United States.

Public Health Relevance
The proposed research is relevant to public health because the prevalence of overweight and obesity is increasing in Hispanic women and young children. The goal of the proposed study is to investigate the efficacy of a nutrition and exercise education, exercise, coping skills training, home-based exercise in Hispanic women and the Color Me Healthy program in their 4-year old children. This project is relevant to NIH’s mission since it will test new strategies to prevent and manage chronic disease in minority mothers and their young children.

Principal Investigator: Lixin Song, PhD, RN, FAAN

Funded by: National Institutes of Nursing Research

Abstract: Over 180,000 men will be diagnosed with localized prostate cancer in 2016 and 92% of these men will have localized or regional disease. Fortunately, treatment with curative intent (surgery or radiation with/without hormone therapy) provides long-term cancer-free survival. However, survivors experience urinary, sexual, bowel and hormonal symptoms, general distress, pain, fatigue, and sleep disturbance. For men in an intimate relationship, these symptoms disrupt couple’s relationships and intimacy, and reduce quality of life (QOL) of both patients and their partners who are often their primary caregivers. Symptom effects may have as great or greater impact on their partners’ QOL than on patients’ own QOL. Management of the negative effects of cancer and its treatment is a significantly under-addressed supportive care need for these men and their intimate partners. Most existing online programs are not couple-focused or use generalized “one-size fits all” approaches that have fallen short of improving QOL. Existing in-person couple-focused programs are expensive and inconvenient because of the time and travel required. To address these unmet supportive care needs, Dr. Song led an interdisciplinary team to develop and pilot test the usability and feasibility of an evidence-based, couple-focused, tailored mobile health (mHealth) intervention, “Prostate Cancer Education & Resources for Couples” (PERC). Based on the adapted stress-coping theoretical framework and developed with stakeholder involvement, PERC aims to improve QOL for both patients and partners through enhancing positive appraisals, self-efficacy, social support, and healthy behaviors for symptom management. Using mHealth technologies, PERC provides comprehensive, user-friendly content, and uses tailoring and personalization features designed to increase personal relevance of, and couples’ accessibility to PERC modules. We propose to rigorously test the efficacy of PERC using a population-based, geographically and demographically diverse cohort in a randomized controlled trial. The specific aims are:

Primary Aim: Assess if patients and partners receiving PERC will report greater improvement in their cancer-related QOL scores than those in the control group (usual care plus the National Cancer Institute (NCI) prostate cancer website) at 4, 8, and 12 months post-baseline.

Secondary Aim: Test if patients and partners in PERC will report significantly more positive appraisals and higher levels of coping resources at follow-ups than those in the control group.

Exploratory Aim: Determine if patient race and ethnicity, education, type of treatment, or couples’ relationship quality moderate the effects of PERC on patient and partner QOL at follow-ups. This study will provide a novel model for self-managing chronic illness symptoms that impact couples’ relationships, intimacy, and QOL. It addresses the National Institute of Nursing Research’s (NINR) goal to develop and test new strategies for symptom self-management to help patients and caregivers better manage their illness and improve QOL. It also responds to calls for programs from the Institute of Medicine (IOM) and American Cancer Society (ACS) to address treatment-related effects and improve survivors’ QOL.

Principal Investigator: Suzanne Thoyre, PhD, RN, FAAN

Funded by: National Institutes of Nursing Research

Abstract: After discharge from neonatal intensive care, a subset of preterm and full-term infants will have elevated risk for compromised development. An estimated 40-70% of these infants will have problematic feeding during the first 24 months. Because problematic feeding may escalate into a chronic feeding disorder, early symptom identification is critical. Linking early physiologic symptoms of problematic feeding with subsequent behavioral symptoms is needed to speed detection, enhance effective symptom management, and disrupt progression from problematic feeding to chronic feeding disorders. A lack of valid assessment that accounts for normal variation in feeding in children’s early development has impeded development of evidence to support a shift to earlier detection and targeted care. To address this problem, our team has developed a set of progressive, valid, reliable measures of symptoms of problematic feeding and eating skill development that can be used from birth through early childhood, with scoring systems that are standardized by age. Two parent-report measures of the child’s feeding environment complete the set. In the proposed study, we will use a concurrent explanatory mixed- methods longitudinal design to prospectively follow 285 infants at risk for feeding problems from discharge from neonatal intensive care through age 24 months. By concentrating assessments in the 1st year with follow-up in the 2nd year, we will study symptoms of problematic feeding across a critical period of development highly sensitive to adequate nutrition and with infants at highest risk for poor outcomes. Aim 1: Characterize children’s symptoms of problematic feeding and trajectories of symptoms from the time of NICU discharge through age 24 months. Aim 2: Determine the relationship of child biological function evident at discharge (neonatal biological risk, feeding skills, cardio-respiratory stability, gastro-intestinal function, autonomic nervous system regulation) and child sex with symptom characteristics and trajectories emerging across the next 24 months. Aim 3: Describe the child’s feeding environment (parent/family demographics; parent strategies to manage problematic feeding symptoms; receipt of feeding specialty services; feeding impact on the parent/family) and its relationship with problematic feeding symptoms from discharge through 24 months. Interviews with a sample subset will allow a more contextual understanding of the child’s feeding environment. Aim 4: Determine the relationship between symptoms of problematic feeding and child outcomes of the development of eating skills, growth, and neurodevelopment. By improving understanding of characteristics of early symptoms of problematic feeding during the period when feeding disorders are emerging, and through better understanding of the family dynamic related to feeding problem development, we can determine common biobehavioral pathways in children’s development of chronic feeding disorders, which will lay the groundwork for development of precision interventions in future research.

Principal Investigator: SeonAe Yeo, PhD, RN, FAAN

Funded by: UNC Center for Diabetes Translation Research to Reduce Health Disparities

Abstract: Sedentariness can lead to excess risk for maternal and child mortality and morbidity. Most pregnant women, however, become sedentary in the 3rd trimester. In our randomized controlled trial with a high-risk group of sedentary overweight/obese pregnant women with a history of preeclampsia, we found that 10 or more weeks of stretching exercise (SE)  reduced the incidence of preeclampsia – a significant risk factor for cardiovascular disease – by lowering blood pressure (BP) and enhancing antioxidant up-regulation and production, compared to walking, to which pregnant women adhered poorly. We plan to test if this effect can be extended to broader populations of pregnant women. From our pilot study of healthy pregnant women, of which 84% were overweight/obese, we reported promising results of the short-term effects of SEs on BP and sympatho-vagal balance. Thus, we propose to test the effects of a novel SE intervention on cardiovascular health in obese pregnant women in the 3rd trimester. We include evidence-based behavioral strategies to enhance adherence. A session of SE includes 30 minutes of sequential static stretching of large skeletal muscle groups for 20 seconds, 3 times per muscle group. Although little is known about cardiovascular effects of SE, our preliminary findings were unexpected yet consistent across our studies. If the findings persist, SE would be an effective, accessible, cost-efficient way for obese pregnant women to promote their health and reduce risk of cardiovascular complications of pregnancy. The study of SE interventions is therefore justified. In this 2-arm RCT we will determine if a SE is superior to a control condition of enhanced usual care (eUC) which includes moderate/vigorous activity, specifically walking, for 30 minutes 5 days/week as recommended by the American College of Obstetricians and Gynecologists. Both the treatment and control arms will receive a supportive behavioral intervention to facilitate adherence. Primary outcomes are BP, sympatho-vagal balance, and arterial stiffness assessed at baseline (27 weeks’ gestation), then at 5 and 10 weeks later, and at 32 and 37 weeks’ gestation.  We will compare SE to eUC (n = 306; 153 per arm) and examine selected cardiovascular functions by which SE may be effective. The Aims are: Aim 1: To test the efficacy of SE intervention on improving cardiovascular health compared to eUC with respect to selected indicators of cardiovascular function (BP, sympatho-vagal balance and arterial stiffness), controlling for anxiety, age, race/ethnicity, BMI, and smoking; Aim 2: To test the efficacy of the SE intervention on maternal, fetal, and neonatal composite outcomes compared to eUC. Aim 3: To explore the relationship between adherence and cardiovascular measures and pregnancy complications. Our goals fit NINR’s strategic goal of promoting health and preventing illness across health conditions, settings, the lifespan, and in minority and underserved populations, who bear higher burden of obesity.  Stretching exercise may be viable for preventing cardiovascular illness and is known to have high acceptance, better adherence, no known untoward side effects, and promising preliminary evidence of effectiveness.

Principal Investigator: Mark Toles, PhD, RN, FAAN

Funded by: National Institute of Nursing Research, National Institutes of Health

Abstract: Seriously ill patients, as they draw closer to the end-of-life, experience multiple transitions between healthcare providers and settings. More than 50% of patients admitted to Skilled Nursing Facilities (SNF) die or return to hospital within 90 days of discharge to home. The proposed efficacy trial of the Connect-Home transitional care intervention is relevant to the NIH’s mission because (a) it has the potential to improve quality of life, function, and acute care use for seriously ill SNF patients, and (b) reduce burden and distress for their caregivers.

Principal Investigator: Kim Boggess, School of Medicine, Obstetrics and Gynecology (Lead) and Diane Berry, School of Nursing

Funded by: NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (2016-2021)

Co-Investigators: Laura Young, School of Medicine, Endocrinology

Abstract: Over 100,000 pregnant women with overt type 2 diabetes (T2DM) give birth in the United States every year. Strict maternal glycemic control is the key to optimizing infant outcomes. Medical treatment of overt T2DM in pregnancy is generally restricted to insulin as data on the safety and efficacy of oral hypoglycemic agents for overt T2DM is limited. However, over one-third infants born to women with overt T2DM experience an adverse outcome such as premature delivery, large-for-gestational age (LGA), hypoglycemia, hyperbilirubinemia, or birth trauma, suggesting that current treatment regimens fall short of optimizing outcomes. We believe that further research is needed to identify better strategies to reduce neonatal complications of overt T2DM in pregnancy. Metformin is the pharmacologic treatment of choice for overt T2DM outside of pregnancy. Metformin is favored over insulin because it results in less weight gain, fewer hypoglycemic episodes, and is oral rather than injectable. Metformin’s mechanism of action directly counteracts the insulin resistance characteristic of T2DM. Metformin is not recommended for treatment of T2DM complicating pregnancy, mainly because there are no large clinical studies examining its use in this context. Research is needed to address this knowledge gap. Our long-range goal is to optimize maternal and infant outcomes in overt T2DM complicating pregnancy. The objective of this proposal is to study the efficacy and safety of adjuvant metformin for treatment of T2DM among pregnant women receiving insulin therapy. Our central hypothesis is that compared to insulin alone, insulin plus metformin will result in improved neonatal outcomes. We will test this hypothesis by prospectively randomizing 1334 pregnant women with overt T2DM to insulin plus placebo therapy versus insulin plus metformin to accomplish the following specific aims: 1: To measure the effect of insulin/metformin on composite adverse neonatal outcome (perinatal mortality-miscarriage; stillbirth or neonatal death; preterm delivery, neonatal hypoglycemia, hyperbilirubinemia, and/or birth trauma); infant birth weight and fat mass, among pregnant women with T2DM.; 2: To measure safety of insulin/metformin use among pregnant women with overt T2DM; and 3: To quantify gestational weight gain (GWG) and satisfaction with therapy among women treated with metformin. Successful completion of this proposal will result in high quality contemporary evidence for management of overt T2DM complicating pregnancy to improve neonatal outcomes.

Principal Investigator: Sheila Santacroce, Jennifer Leeman

Funded by: National Institute of Nursing Research (1996-2021)


Abstract: The purpose of this research training grant renewal application is to prepare nurse scientists with capacities to develop theory-based interventions for preventing and managing chronic illness with a new emphasis on accelerating translation into practice. The T32 has matured over the last 20 years of funding; its focus has expanded to address emergent priorities in research on theory-based interventions for preventing and managing chronic illness as well as to reflect the strength and diversity of our faculty research. In this application, we address the imperative to speed the translation of research findings to practice for the improvement of patient and population health outcomes. The program is conceptualized around a paradigm that posits two approaches to speeding translation: designing interventions with implementation in mind and applying rigorous approaches to disseminating and implementing research findings. Our continued focus on theory-based interventions will be enhanced by a new focus on translational science and training in five translation catalysts: dissemination and implementation science, stakeholder engagement, patient-centered outcomes, pragmatic and adaptive trial designs, and mixed methods. For predoctoral trainees, enhancements to the PhD program will include: courses structured to address the five translation catalysts; mentored research experiences; and participation in seminar series concentrated on development as a scientist and on promoting translation of intervention research to practice. For postdoctoral trainees, the training program also will include independent research experiences and active involvement in interdisciplinary seminar series. A total of 14 predoctoral trainees and 10 postdoctoral trainees will be supported over the 5 years of the training program. The emphasis on the five new areas will capitalize on our faculty strengths, strong research infrastructure, and well-established partnerships on The University of North Carolina at Chapel Hill campus and throughout the rural and racially diverse state of North Carolina.

Completed Projects

Principal Investigator: Hudson Santos, PhD, RN

Funded by: National Institutes of Nursing Research (2018-2019)

Abstract: The overall goal of this application is to establish relationships among DNA methylation, maternal hardship and neurodevelopmental impairment in extremely preterm children. The central hypothesis is that maternal hardship clusters are associated with neurodevelopmental outcomes, especially cognitive and affective impairment, in extremely preterm children and that this relationship is mediated by DNA methylation in the placenta. The study will examine a diverse sample of extremely preterm children (N = 889) drawn from the Extremely Low Gestational Age Newborns Study (ELGAN, #1UG3OD023348-01). ELGAN is a multi-center longitudinal study of the risk of neurologic disorders in extremely preterm children. I will combine existing data on (1) prenatal maternal hardship; (2) DNA methylation from placental specimens; and (3) neurodevelopmental impairment, specifically cognitive and affective outcomes at ages 2 and 10. Furthermore, I will be involved in the third phase of ELGAN follow-up to collect neurodevelopmental impairment data on participants at age 15.

The Specific Aims are to (1) Establish maternal hardship clusters using prenatal socioeconomic and stressful life events factors; (2) Identify associations between maternal hardship clusters and child cognitive and affective outcomes at ages 2, 10 and 15 years; and (3) Determine the extent to which DNA methylation mediates the relationship between maternal hardship and cognitive and affective outcomes. This research aligns closely with NINR?s Innovative Question 2.6 on etiological pathways to prevent chronic illnesses with known risk factors in childhood. My research background is in nursing, with specific foci of maternal hardship, perinatal affective symptoms in minority and/or other vulnerable mothers, and related child outcomes. My short-term career goal is to expand my research to link maternal hardship to epigenetic mechanisms and neurodevelopmental outcomes among at-risk children. The proposed training activities will include formal didactic, hands-on instruction and research immersion in epigenetics, the biological bases of child neurodevelopment; experience in large interdisciplinary teams; responsible conduct in research; and publications and attendance at conferences. I have assembled an interdisciplinary mentoring team of internationally recognized experts. This award will move me to independence as a researcher, support my next steps in securing funding, and help me achieve my long-term goal of becoming a nurse leader in longitudinal research to prevent or minimize neurodevelopmental impairment related to maternal hardship among at-risk children. My subsequent R01 will explore additional epigenetic pathways related to hardship. I plan to use the 35 cohorts of the NIH Environment influences on Child Health Outcomes (ECHO Program; ~ 40,000 children by 2019), which includes ELGAN, to identify modifiable factors that could be potential targets for interventions.

Public Health Relevance
This research is relevant in its investigation of placental DNA methylation as a mediator of the association between maternal hardship and neurodevelopmental impairments in extremely preterm children. This study will provide the groundwork to inform interventions to reduce mothers? stress responses and children?s neurodevelopmental impairment, thereby improving quality of life for the 16,500 families with a child surviving extremely premature birth annually in the US.

Principal Investigator: Linda Beeber, PhD, RN, FAAN

Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (2016-2018)

Co-Investigators: George Knafl and Julee Waldrop, School of Nursing and Dore LaForett, Frank Porter Graham Child Development Institute

Abstract: This two-phase project will test the feasibility of integrating into Early Intervention (EI) services an intervention to enhance communication between infants and toddlers with diagnosed or suspected developmental disabilities and their depressed mothers. Federally-funded EI services are provided in all 50 states to infants and toddlers with developmental delays to improve long-term child cognitive and behavioral outcomes. EI services are optimized when the child receives consistent developmentally supportive activities as part of the family’s normal routines throughout the day, every day. EI services frequently include parent-implemented language enrichment interventions to increase child-centered speech and reciprocal (turn-taking) communication, which have been linked to positive child outcomes. Such interventions are dependent on consistent parent attentiveness, reciprocal interactions, and sensitivity to child cues. Depressive symptoms, prevalent in mothers of EI-enrolled children, can rob mothers of these capabilities. Fortunately, providing depressed mothers with concrete, attainable skills for improving interactions with their child can reduce the impact of depression on mother and child. EI is an ideal setting in which to integrate screening, support, and targeted communication skills for depressed mothers in order to improve EI child outcomes. First, we will use focus group and interview data to tailor a toolkit and training program for EI staff and determine whether it is feasible for staff to identify, screen and support mothers with depressive symptoms. Data on the toolkit will be collected from 4 EI staff on feasibility (ease of use, time required) and acceptability to mothers. Then, we will determine whether it is feasible for mothers to engage in an intervention to increase their child-centered speech and reciprocal communication using a technology-supported Language ENhancement Assessment/intervention system (LENA) embedded in EI services. The LENA uses an infant or toddler garment with an integrated audiotape device that records adult speech centered on the child, child vocalizations, and reciprocal turn-taking conversations between parent and child. The LENA software produces visual feedback that a mother can use to focus her language-based interactions with her child. The LENA-supported communication feedback intervention will be implemented with 10 mothers and 10 EI staff by using LENA one day a week for 16 consecutive hours for three consecutive weeks. Feasibility data, LENA communication data (adult word count, child vocalizations and conversational turn-taking), the Communication and Symbolic Behavior Scale, maternal depressive symptoms (PHQ-9) and child disability profiles (Mullen Scales of Early Learning) will be analyzed to determine the potential usefulness of the approach. The tailored intervention package will be designed for maximum scalability, with the ultimate goal of use by EI professionals across the country to enhance mother-child communication and maximize EI outcomes for children.

Principal InvestigatorJada Brooks, PhD, MSPH, RN

Funded by: NIEHS (2016-2018)

Mentors: David Peden, Pediatrics and Barbara Fredrickson, Psychology and Neuroscience

Scientific Advisors: Linda Beeber, School of Nursing and Giselle Corbie-Smith, Social Medicine

Biostatistician: Josephine Asafu-Adjei

Abstract: American Indian women experience particularly high mortality and morbidity from cardiovascular disease (CVD). Reducing this burden requires addressing preventable factors in the physical and psychosocial environment that are known to be important for the inflammatory responses involved in CVD. However, there is little evidence about the roles of environmental pollutant exposures and psychosocial factors in shaping immunologic function in American Indian women. This Mentored Patient-Oriented Research Career Development (K23) Award, entitled Inflammatory Markers, Hazardous Air Pollutants, and Psychosocial Factors proposes to address inflammation as a potential biological pathway linking environmental pollutant exposure and psychosocial factors to CVD in American Indian women. The working hypothesis is that American Indian women with positive psychosocial states are less susceptible to the inflammatory effects of environmental pollutants. The study will examine a sample of American Indian women (N = 150) drawn from southeastern North Carolina. A variety of assessment methods will be used, including survey methods, exposure assessment, and serum biomarker. Three Specific aims are to: 1) examine the association between environmental pollutants and inflammation in American Indian women; 2) examine the association between psychosocial states and inflammation in American Indian women; and 3) determine whether psychosocial states moderate the association between environmental pollutants and inflammation in American Indian women. With a background in nursing and epidemiology I am focusing my research on using community-based approaches to investigate relationships among environmental pollutants, psychosocial states, biological outcomes, and health disparities, particularly among American Indian women. The proposed training activities will include formal didactics and hands-on instruction in measurement and interpretation of environmental data, positive psychosocial states, and serum bioscience methods; community-engagement methods; responsible conduct in research; and attendance at national conferences. I have assembled an interdisciplinary mentoring team of internationally recognized experts who will provide me guidance in building new skills in environmental epidemiological measurement, psychosocial research, and serum biomarker measurement and analysis. The K23 award will move me to independence as a researcher, support my steps in securing funding as an independent investigator, and help me to become a nurse leader in environmental health disparities.

Principal Investigator: Jada Brooks, PhD, MSPH, RN

Funded by: National Institute on Drug Abuse via Florida Atlantic University Subcontract (2014-2019)

Co-Investigators: None

Abstract: Not available

Principal InvestigatorEric Hodges, PhD, FNP-BC

Funded by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (2016-2018)

Co-Investigators: Cathi Proper, UNC Center for Developmental Science; and Todd Schwartz, UNC School of Nursing

Abstract: Once obese as an infant, the relative risk of remaining obese appears to rise with increasing age. Thus, the early years of life have been posited as an important target period for obesity prevention. Widely viewed as a response to genetic, interpersonal, and environmental factors, obesity fundamentally reflects an imbalance between energy intake and expenditure. Self-regulation of energy intake aligned with physiologic need is essential to this balance. The process(es) by which infants begin to disassociate eating behavior from physiologic need is unclear, thus it is crucial to better understand predictors of individual differences in self-regulation of energy intake. It is well established that autonomic regulation may support infant behavioral regulation, suggesting that autonomic function may be a critical area to consider here. Moreover, self-regulation is strongly influenced by dyadic interaction quality during infancy, and findings reveal that more responsive interactions are associated with more effective autonomic regulation. A chronic mismatch between a caregiver’s feeding behavior and the infant’s state (feeding in the absence of hunger and/or feeding beyond fullness), is thought to contribute to obesity by undermining the infant’s capacity to self-regulate intake; the current proposal will be the first to examine the effects on autonomic regulation.

We propose an intervention to enrich the capacity of mother-infant dyads to perform their respective interactive tasks. We plan to teach mothers American Sign Language (ASL) signs indicative of hunger, thirst, and satiety, which they will in turn teach their preverbal infant. This training in ASL will be augmented with targeted information for mothers about infants’ capacities to self-regulate energy intake in response to hunger and satiety and communicate those states with intention.  Mothers also will be taught about expected development of infants’ eating behaviors and nutritional requirements to support healthy growth.

Using a two-group randomized repeated measures design, this study aims to 1) evaluate the feasibility and acceptability of the intervention and study methods, including recruitment, enrollment, and data collection (self-report, anthropometrics, video observations, and respiratory sinus arrhythmia [RSA]) for infants and their mothers; 2) evaluate the initial impact of the intervention on observed feeding interactions, reported infant feeding behaviors and maternal feeding behaviors/beliefs, and infant nutritional intake and growth; and, 3) explore preliminary data on concordance between dyadic feeding interactions and autonomic regulation in both mothers and infants (RSA). In addition to a variety of self-report and anthropometric measures, this study will use integrated behavioral (video) and physiologic (RSA) measures to better understand feeding dynamics and their relationship with obesity risk. Understanding these processes is essential for developing appropriate preventions, or interventions, that will help reduce the prevalence of early childhood obesity and its extension into later childhood and beyond.

Principal Investigator: Kathleen Knafl, PhD, FAAN

Funded by: National Institutes of Health via subcontract with Childrens National Health System, Children’s Research Institute

Principal Investigator: Kathleen Knafl, PhD, FAAN

Funded by: National Cancer Institute via subcontract with University of Pennsylvania


Principal Investigator(s): Core: Alice Ammerman, Jennifer Leeman, DrPH, MDIV, and Sam Cykert; Center: Alice Ammerman

Funded by: Centers for Disease Control and Prevention via UNC Center for Health Promotion and Disease Prevention (2014-2019)

Principal Investigator: Jennifer Leeman, PhD, MDiv

Funded by: Centers for Disease Control and Prevention/National Institutes of Health (2014-2019)

Co-Investigators: Noel Brewer and Kurt Ribisl, Health Behavior; Stephanie Wheeler, Health Policy and Management

Abstract: Cancer has overtaken heart disease as the leading cause of death in North Carolina (NC), and disparities in cancer care and outcomes persist across racial, ethnic, and economic groups. To reduce cancer incidence and mortality, we will promote the adoption and implementation of evidence-based approaches (EBA) to cancer prevention and control (CPC). The Comprehensive Cancer Control Collaborative of North Carolina (4CNC) proposes to continue to contribute to the Cancer Prevention and Control Research Network’s (CPCRN) mission to facilitate uptake of evidence-based CPC interventions through research, training, and technical assistance. 4CNC has developed robust community-academic partnerships with researchers, care providers, and communities across North Carolina to promote the use of EBA to prevent cancer, increase screening, and enhance access to cancer care for all North Carolinians.  4CNC proposes to further develop its established organizational infrastructure to collaborate with CPCRN and with its strong local partners to accelerate the adoption of evidence-based CPC in NC communities and across the nation. We plan to move further along the discovery to delivery continuum by also engaging in research on how to disseminate and implement EBA to improve cancer outcomes among individuals, in communities, and across health care systems. We propose continuing our work to prevent and control colorectal cancer, eliminate disparities in breast cancer screening, prevent cervical cancer through increased HPV vaccination and reduce the impact of tobacco use. In partnership with CPCRN and our 4CNC local partners, our aims are:  (1) Maintain and enhance existing 4CNC infrastructure to (a) further develop local and CPCRN partnerships and activities, (b) identify and rapidly respond to priority areas and emerging issues, (c) initiate and support CPC, dissemination, and implementation research and evidence-informed practice, and (d) more rapidly and broadly disseminate 4CNC products and results to partners at the local, state, and national levels as well as to funding entities and CPCRN members; (2) Advance the science and practice of dissemination and implementation research across the cancer continuum with a focus on (a) preventing cervical cancer via HPV vaccine uptake, (b) eliminating disparities in breast cancer screening and treatment, and (c) preventing initiation and promoting cessation of tobacco use; and (3) Create a community and research-based infrastructure, including a cross-CPCRN project, to support and  inform implementation of Community Guide recommendations to increase CRC screening in NC, with a special emphasis on increasing use among minority and uninsured individuals.

Principal InvestigatorMary R. Lynn, PhD

Funded by: National Council of State Boards of Nursing (2016-2018)

Co-Investigators: Cheryl Jones, UNC School of Nursing

Abstract: Within the last 15 years hundreds of transition programs for new graduate registered nurses (NGRNs) have been launched yet, to date, no study has been located that characterizes these programs or compares them on essential components such a length, content, structure or outcomes. Yet transition programs are in place in virtually every hospital in the U.S. This project has been designed to fill that gap.  This study will be done in two phases, each done collaboratively with a 10-member Advisory Board. The Advisory Board members represent a diverse population all with interests in transition programs – four head staff development departments, three of which have transition programs in their department, one is a chief nursing officer whose hospital started its own program, one in a clinical researcher involved in a national transition program, another an academic research who studies new graduate registered nurses, and the remaining members are a national-expert in nursing education, a sociologist with research experience in nursing-related workforces, and the director of a large national transition program. In Phase I, 1,400 U.S. hospitals will be randomly sampled from the AHA list of hospitals and their nursing education director asked to complete an assessment of their program for transitioning nurses as well as to provide characteristic data about their hospital. The Advisory Board will work to develop a schema to classify the transition program in 2 to 3 major characteristics (e.g., length, content) which will then have sub-categories developed. These will, in turn, be used for the sampling for Phase II where a hospital within each “cross-category” will be contacted and asked for the opportunity to recruit up to 24 new graduate registered nurses (540 NGRNs is the desired final sample) to complete several outcome instruments at the beginning, middle and end of their first year of employment.  All data collection will occur online. The questions to be addressed include identifying the characteristics of transition programs for new graduate registered nurses in the U.S., exploring the relationship between variable in the domains of the NGRN, the program and the hospital, comparing NGRN across time and classification categories, and attempting to predict the NGRN outcome measures from the program and/or hospital characteristics. This study has implications in terms of the knowledge to be gained about transition programs in nursing and to inform regulatory bodies about the characteristics to consider if these programs are to be required before a nurse is “fully licensed.”

Principal Investigator: Lixin Song, PhD, RN

Funded by: National Cancer Institute, National Institutes of Health (2016-2018)

Co-Investigators: Deborah Mayer and Josephine Asafu-Adjei, School of Nursing; Ronald Chen, School of Medicine; and Sarah Birken, School of Public Health

Consultant: Laurel Northouse, University of Michigan

Abstract: Supporting NIH’s mission, this project aims to explore a new model of care that enhances survivorship care planning and promotes health for patients with localized prostate cancer (PCa) transitioning to post-treatment self-management. Survivorship care planning for patients with PCa is important because of the high incidence rates of PCa in the U.S., the frequent occurrence of treatment-related side effects, and reduced quality of life (QOL) in both patients and their partners (for patients who are partnered). Emerging evidence suggests that use of regular survivorship care plans (SCPs) does not improve health service and patient outcomes because the content in mandated SCPs does not consider patients’ information and care needs. We plan to integrate an evidence-based, theory-driven symptom self-management program, Prostate Cancer Education & Resources for Couples (PERC), with standardized SCPs and build enhanced SCPs (ESCPs). ESCPs will engage both patients and partners during survivorship care planning and provide a one-stop, comprehensive PERC program to improve their QOL and decrease patient use of post-treatment care services. The couple-focused, web-based tailored PERC program includes 12 online modules with assignments, a moderated chat room and a resource center. Tailored to patients’ and partners’ characteristics and preferences to address their specific care needs, PERC helps couples reduce negative appraisals of symptoms, increase access to social support, and enhance self-efficacy and health behaviors for symptom self-management. In this study, we propose to test the feasibility of ESCPs (regular SCPs with the PERC web link) and to conduct an initial benefit assessment of ESCPs. We will use a two-group (ESCP=intervention and SCP only=negative control) randomized controlled pretest-posttest design and collect data at baseline (T1) and 4 months later (T2) among 50 patients completing initial treatment for localized PCa and their partners. The specific aims are: Aim 1: Examine the feasibility of delivering ESCPs (as assessed by recruitment, enrollment, and retention rates, satisfaction with ESCP, and perceived ease of use of PERC). We will use mixed methods to achieve this aim. Aim 2: Estimate the magnitude of benefit of ESCPs. We hypothesize that, compared with the SCP only users, the ESCP users will report (1) greater improvement in their primary outcomes of QOL (overall, physical, emotional, and social QOL); (2) greater improvement in secondary outcomes (reduction in negative appraisals and improvement in self-efficacy, social support, and health behaviors to manage symptoms); and (3) fewer visits to post-treatment care services from between T1 and T2. The results from this study will help design a definitive randomized trial to test the efficacy of ESCP. The innovative ESCPs will strengthen survivorship care planning and allow PERC to be disseminated broadly and systematically without the need for costly resources or personnel. This proposed project is in response to calls for programs from the Institute of Medicine and American Cancer Society to address treatment-related effects and help cancer survivors maintain their QOL.

Principal Investigator: SeonAe Yeo, PhD, RN, FAAN

Funded by: UNC Center for Diabetes Translation Research to Reduce Health Disparities