Studies Supported by the YSN Biobehavioral Laboratory

BRIGHT 1 BODIES: EXTENDING THE BRIGHT BODIES WEIGHT MANAGEMENT PROGRAM TO ADOLESCENTS WITH TYPE 1 DIABETES

PI: Garrett Ash, PhD, NSCA-CSCS, Yale School of Nursing, Post-Doctoral Fellow

Co-investigators: Margaret Grey, DrPH, RN; Kevin Joiner, PhD, RN, ANP-BC; Stuart A. Weinzimer, MDl; Mary Savoye, RD; Matthew Stults-Kolehmainen, PhD, ACSM-EP-C; Neha Patel, MD; Mahua Choudhury, PhD; Julien Baker, PhD, DSc

Funding: Biobehavioral Laboratory; Susan Miller Funds; Friends of Yale New Haven Children’s Hospital Elephant Grants; New England Chapter of the American College of Sports Medicine New Investigator Award

Abstract: More youth with type 1 diabetes (T1D) have been developing overweight each year since the 1990s, which is alarming since T1D patients already bear elevated risk of heart disease that is exacerbated by weight gain.  The purpose of this study is to pilot test a 12-week intensive lifestyle program for adolescents with T1D who are also overweight and sedentary utilizing group exercise classes from Bright Bodies adapted for this population, supplemented with coping skills training and diabetes self-management education to address problem solving behaviors that limit their physical activity and weight control. Families will attend the Bright 1 Bodies family-based intensive lifestyle program once or twice per week at Celentano Magnet School in New Haven. We hypothesize this program will increase habitual activity levels measured by accelerometry and improve body composition, cardiovascular health, and diabetes management.


TOXIC STRESS AND PROTECTIVE FACTORS IN MULTIETHNIC SCHOOL AGED CHILDREN

PI: Eileen Condon, MSN, APRN, FNP-BC, PhD Candidate, Yale School of Nursing

Mentors: Lois Sadler, PhD, RN; Linda Mayes, MD

Funding: Biobehavioral Laboratory; NIH F31NR016385; NAPNAP Foundation Research Grant; Connecticut Nurses Foundation award; STTI Alpha Nu Chapter Research Award

Abstract: Exposure to stressful environments in early childhood can cause a toxic stress response and subsequently lead to poor health outcomes. The purpose of this study is to examine maternal caregiving characteristics that may protect against the physiological, health and behavioral indicators of a toxic stress response in children within families at high risk for exposure to stressors such as poverty, trauma or exposure to violence. Framed by an ecobiodevelopmental model, the proposed study employs a cross-sectional design to describe and examine associations among maternal characteristics, maternal caregiving patterns, and indicators of exposure to chronic stress in a multiethnic, urban sample of mothers and children at early school age.


SLEEP, COPING, AND ADJUSTMENT IN ADOLESCENTS WITH TYPE 1 DIABETES

PI: Margaret Grey, DrPH, RN, Annie Goodrich Professor, Yale School of Nursing

Funding: Biobehavioral Laboratory; Susan Miller Funds; NIH P20NR014126

Abstract: The purpose of this pilot study is to evaluate the characteristics of sleep, perceptions of barriers and facilitators to adequate sleep, and the associations between sleep, executive function, coping, adherence, glucose excursions, and adjustment in adolescents with type 1 diabetes. We use a mixed methods approach that includes a quantitative component, consisting of actigraphy and sleep diaries, questionnaires, continuous glucose monitoring, and tests of executive function, and a qualitative component, using narrative analysis. We are recruiting a sample of 40 adolescents with T1D.


STRESS BIOMARKERS AND EPIGENETICS IN RESPONSE TO A BEHAVIORAL INTERVENTION

PI: Margaret Grey, DrPH, RN, Annie Goodrich Professor, Yale School of Nursing; Jacqueline Taylor, PhD, Associate Professor, Yale School of Nursing

Funding: Biobehavioral Laboratory; Susan Miller Funds

Abstract: In this pilot/feasibility study, the aims are to: (1) Determine the feasibility and reliability of collection of saliva for the measurement of the cortisol awakening response (CAR), salivary alpha amylase (s-AA), and salivary immunoglobulin A (s-lgA) at awakening and 30-45 minutes later over 3 days at home in 20 youth (age 11-14 years) with type 1 diabetes; (2) Conduct a pilot study of Teens.Connect, an internet-based diabetes education and coping skills training program, with 40 youth to determine whether alterations in stress biomarkers are associated with self-reported perceived stress and HbA1c; and (3) Examine the gene-environment interaction (GXE) of the top 14 targeted candidate genes for stress and T1D and DNA methylation effects of teens’ stress biomarkers and their influence on HbA1c levels over time. Feasibility will be determined by the percent of youth who consent and complete saliva collection reliably. In the pilot study, 40 youth will be randomly assigned to participate in the Teens.Connect program or wait list control with measurements of perceived stress and CAR, s-AA, and s-IgA at baseline, and 3 and 6 months. For aim 3, candidate genes will be measured at baseline and DNA methylation patterns will be measured at baseline and at 6 months to determine if these patterns moderate outcomes. Analyses for aims 2 and 3 will involve linear mixed methods analyses. If successful, the project could lead to a precision behavioral approach to improve diabetes outcomes in these high-risk youth.


RESTLESS LEGS SYNDROME AND THE MELANOCORTIN AXIS

PI: Brian Koo, MD, Yale School of Medicine, Department of Neurology

Funding: Biobehavioral Laboratory

Abstract: Restless Legs Syndrome (RLS) is a common disease affecting between 5% and 10% of US adults; however, little is known about its underlying biology. We are interested in studying a hormone and its accompanying hormonal system, alpha-melanocyte stimulating hormone, that when given to rat recapitulates an RLS-like state. Alpha-melanocyte stimulating hormone (alpha-MSH) has diverse functionality, but is involved in the initiation of movement, sensitization to pain, sleep disruption, metabolism, and inflammation, some of these features being consistent with one or more features of RLS. In our study, we are interested in determining if levels of alpha-MSH in blood and cerebrospinal fluid are increased in persons with RLS, and further if these levels of hormone correlate to severity of disease and other selected neurobehavioral symptoms and neurophysiologic phenomenon.


SLEEP, BIOLOGICAL STRESS, AND HEALTH IN A COMMUNITY SAMPLE OF TODDLERS LIVING IN SOCIOECONOMICALLY DISADVANTAGED HOMES

PI: Monica Ordway, PhD, APRN, PNP-BC, Assistant Professor, Yale School of Nursing

Mentors: Nancy S. Redeker, PhD, RN; Lois Sadler, PhD, RN; Gail Page, PhD, RN

Funding: Biobehavioral Laboratory; Susan Miller Funds; NIH K23NR016277; NIH UL1TR000142; NIH KL2TR000140

Abstract: Consistent with other health disparities, young children living with adversity are especially vulnerable to sleep difficulty beginning within the first year of life. The purpose of this study is to examine the relationships among sleep characteristics, stress, and health among toddlers (12 months) living with socioeconomic adversity. Subjective and objective data on sleep characteristics, multiple salivary and hair biomarkers of stress, and parent-reported child behavior will be measured. Data from this study and the complementary work conducted at YSN will be used to support future studies to understand the relationships among sleep, stress, and health. By following these children over time with additional measures of stress and health we aim to identify causal pathways and ultimately test the effects of interventions, such as those that may improve sleep, among young children at risk for toxic stress.


MECHANISMS OF SLEEPINESS SYMPTOMS IN SLEEP APNEA AND CARDIOVASCULAR DISEASE

PI: Victoria Pak, PhD, RN, Assistant Professor, Yale School of Nursing

Co-investigators: Nancy S. Redeker, PhD, RN; Klar Yaggi, MD, MPH

Funding: Biobehavioral Laboratory; R00NR014675 NIH Pathway to Independence Award

Abstract: The purpose of this study is to investigate relevant genetic markers that link to sleepiness among patients with obstructive sleep apnea. We hypothesize that a different frequency of polymorphisms in genes such as NOX-2, NOX p22phox, tumor necrosis factor-alpha (TNF-alpha), and PDE4D, will modify the degree of sleepiness symptoms in individuals with similar degrees of sleep-disordered breathing. We will use a case-control study to recruit 64 sleepy and 64 non-sleepy OSA patients to determine whether elevated genetic and biological markers are related to sleepiness symptoms. Blood and urine samples will be obtained after polysomnography. EDS symptoms will also be measured by using the Epworth Sleepiness Scale (ESS) and the Psychomotor Vigilance Test (PVT). Cardiovascular risk measures [ambulatory blood pressure (ABP) and Pulse-Wave Velocity (PWV)] will also be obtained at this time.


COGNITIVE BEHAVIORAL THERAPY FOR INSOMNIA: A SELF-MANAGEMENT STRATEGY FOR CHRONIC ILLNESS IN STABLE HEART FAILURE

PI: Nancy S. Redeker, PhD, RN, Beatrice Renfield Term Professor of Nursing, Yale School of Nursing

Co-Investigators: Henry Yaggi, MD, MPH; Daniel Jacoby, MD; Christopher Hollenbeak, PhD; Sangchoon Jeon, PhD

Funding: Biobehavioral Laboratory; NIH R01NR016191

Abstract: The purposes of this randomized controlled trial are to evaluate the sustained effects of Cognitive Behavioral Therapy for Insomnia (CBT-I), compared with heart failure (HF) self-management education (attention control), on insomnia severity, sleep characteristics, daytime symptoms, and functional performance over twelve months among patients who have stable chronic HF and chronic insomnia and receive evidence-based HF disease management. We will also evaluate the cost-effectiveness of CBT-I compared with the attention control condition and explore the effects of CBT-I on event-free survival. A total of 200 patients will be randomized to 4 bi-weekly sessions of group CBT-I or an attention control condition consisting of HF self-management education. Wrist actigraph measures of sleep, diaries, psychomotor vigilance and 6-minute walk test distance, and self-report measures of insomnia, sleep, symptoms, and functional performance will be obtained at baseline and follow-up. Data analysis will consist of mixed effects models, latent transition analysis, stochastic cost effectiveness analysis, and survival analysis.


COMMUNITY PARTNERSHIP FOR HEALTHY SLEEP

PIs: Nancy S. Redeker, PhD, RN, Beatrice Renfield Term Professor of Nursing, Yale School of Nursing & Lois Sadler, PhD, RN, PNP-BC, FAAN, Professor, Yale School of Nursing

Co-investigators: Nancy Banasiak, MSN, RN; Monica Ordway, PhD, APRN; Ada Fenick, MD; Craig Canapari, MD; Barbara Caldwell, PhD, RN

Funding: Biobehavioral Laboratory; NIH R21NR016190

Abstract: This study, guided by the Social Ecological Model, will use a community engaged (CEnR) approach and mixed methods to obtain foundational information in support of a community-engaged sleep promotion program for children between 6 and 36 months of age who are living with economic adversity. We will use a convergent mixed methods approach to engage the community and collect quantitative and qualitative data regarding children’s sleep and sleep habits and parent and provider perspective on sleep, sleep habits, and sleep promotion intervention. We expect that the results will lead to a future randomized controlled trial (RCT) that will examine the sustained effects of a community engaged sleep promotion program on sleep habits, sleep, and sleep-related outcomes among young children who live in economically stressed urban environments. Our long term goal is to disseminate and translate an efficacious sleep promotion intervention into community settings.


MINDING THE BABY® HOME VISITING PROGRAM: MEASURING BIOMARKERS OF CHRONIC STRESS IN YOUNG MOTHERS AND THEIR TODDLERS

PI: Lois Sadler, PhD, RN, PNP-BC, FAAN, Professor, Yale School of Nursing

Co-investigators: Arietta Slade, PhD; Nancy Close, PhD; Monica Ordway, PhD, APRN

Funding: Biobehavioral Laboratory; Susan Miller funds; FAR fund; Child Welfare Fund; Edlow Family Foundation

Abstract: Aims of this feasibility study include evaluating acceptability and feasibility of collecting biomarkers of chronic stress from participants enrolled in the Minding the Baby® (MTB) program – an intensive relationship-based reflective parenting home visiting intervention.  We will collect hair (cortisol) and saliva (salivary IL6) in young mothers and their children enrolled in the program. Baseline measures are collected from mothers during the last weeks of the third trimester of pregnancy. When the child is 24 months of age and the dyad graduates from the program, repeat measures (hair and saliva) are collected from the mother and a set is also collected from her child. We have been successful in collecting 9 sets of baseline measures and two sets of mother and child samples at the 24-month time period. This procedure appears to be acceptable to parents.  The first set of baseline biomarkers have been analyzed and the 24 month sets will be analyzed when the 10 dyads have completed samples collected. Participants’ cortisol and IL6 values will be compared to published norms for the two measures.