Clinical trials

The purpose of this study is to examine how participating in exercise together versus separately influences brain function, cognitive performance, mood, and parent-child connection in mother-child dyads. Mothers and their children will complete two fitness class visits at a participating community fitness facility/CrossFit affiliate. During one visit, mothers and children will exercise in separate age-appropriate classes, and during the other visit they will exercise together in a shared class. Before and after each exercise session, participants will complete brief assessments of cognition, mood, and brain activity using a portable electroencephalography (EEG) device. Findings from this pilot study will help determine the feasibility of conducting community-based neuroscience research and may inform future family-centered physical activity programs designed to support brain, emotional, and social health.

The frequency and severity of heat waves has increased in the last decades. Older adults (over 65 years) have impaired responses to heat stress making them at increased risk for adverse events. Previous heat waves report that women over 65 experience worse health outcomes than any other age group and age matched men. Aging and reproductive hormones, specifically estrogen, independently alter responses to heat stress. However, the combined effects of low estrogen following menopause and aging on the response to heat stress are unknown. In this study, the investigators will identify the role of estrogen in pre and post menopausal women on thermoregulatory responses to heat stress.

The overall goal of this research is to provide pilot data that informs and drives a larger scale research project, incorporating multiple contemporary measurement modalities, to understand the utility and pathological mechanisms by which exposure to nature-based settings may aid in recovery time and symptom relief of individuals suffering from concussion, and decrease their risk of developing Persistent Post-Concussion Syndrome (PPCS). We hypothesize that successful adherence to a nature-based exposure therapy intervention program will decrease recovery time and severity of symptom trajectory of concussion, as measured through multimodal assessments of brain structural and functional integrity.

The purpose of this study is to investigate the effects of replacing snacks higher in saturated fats and added sugars with pecans on blood sugar control, heart health and diet quality in individuals with prediabetes. Participants will be randomized into one of two groups. Group 1 will consume 1.5 oz of pecans per day in place of normally consumed snacks higher in saturated fat and added sugars for 16 weeks. Group 2 will be asked to continue consuming their current diet for 16 weeks. Measures will be taken to evaluate blood sugar, heart health and dietary intake at the beginning and 16 weeks later.

The purpose of this study is to find out if full-fat dairy and low-fat dairy have similar effects on risk factors for heart disease and diabetes. During the study, participants will consume two types of dairy products: low-fat dairy (milk, yogurt, and cheese) and full-fat dairy (milk, yogurt, and cheese). Each type of dairy will be consumed for 6 weeks with a ≥4-week break between. Measures will be taken to evaluate blood cholesterol, blood sugar, body weight, inflammation, blood pressure, heart health and dietary intake at the beginning and end of each 6 week period.

The proposed study will examine whether eating yogurt every day can improve brain and gut health in children. Prior research suggests that yogurt may support cognitive functions like self-control, but more studies are needed to confirm this. The study will follow 60 children from Central Pennsylvania, ages 8 to 10, who will be randomly assigned to drink either fruit juice (control group) or yogurt smoothies once or twice a day for four weeks. Researchers will compare how different amounts of yogurt affect children's thinking skills (like memory and focus), brain activity, and gut bacteria. These changes will be measured through brain scans, computer-based thinking tasks, surveys, and stool samples. The study will also collect information about children's overall diet. The goal is to find out if yogurt can support healthy brain and gut development and to determine the right amount to include in a child's daily diet. Results will help guide future research on how nutrition supports children's health.

Strong empirical evidence shows food marketing promotes excess energy intake and obesity. Yet, not all children are susceptible to its effects and this variability is poorly understood. Identifying sources of this variability is a public health priority not only because it may elucidate characteristics of children who are most susceptible, but also because it may highlight novel sources of resiliency to overconsumption. The proposed research will use state-of-the art, data-driven approaches to identify neural, cognitive and behavioral phenotypes associated with resiliency to food-cue (i.e. food advertisement) induced overeating and determine whether these phenotypes protect children from weight gain during the critical pre-adolescent period.

The goal of this clinical trial is to learn if intervention with Landing Place mental health app can support wellness in college students. The main questions it aims to answer are: Can the app increased well-being in college students? Will the app have increased use and usability by the college students? Researchers will compare two groups of participants to see if the app intervention will increase wellbeing and app usability rates. Participants will randomly assigned into group 1 and 2. Group 1 will not use the app at all. Group 2 will use the app almost every day for 4 weeks.

Most attempts to quit smoking end in relapse, or a return to regular smoking. One of the biggest threats to cessation is a lapse (i.e., any cigarette use during a quit attempt). Thus, characterizing why lapses occur is essential to understanding and preventing smoking relapse. Functional magnetic resonance imaging (fMRI) is a promising method for characterizing the psychological processes that lead to smoking lapses because it provides a way to measures patterns of brain activity thought to reflect relevant mental processes as they change over time. However, methodological issues have hindered the ability to capitalize on this potential and prevented an understanding of how brain activity and corresponding psychological processes unfold in the critical moments that immediately precede a smoking lapse. The proposed project will address this knowledge gap using a novel fMRI paradigm adapted from a well-validated behavioral lapse task. The goals of the project are to characterize changes in brain activity that lead up to a lapse and to investigate how these changes are related to concurrent affect and subsequent cigarette use.

The purpose of this randomized control trial is to compare how food cravings, food selection, and food consumption change in response to frequent food advertisements compared to non-food advertisements in adults taking GLP-1 (weight loss) medications. The primary question we aim to answer is: do GLP-1 medications reduce an individual's vulnerability to external triggers that drive food cravings and consumption? Participants will: * report daily food consumption for a total of 10 days, * receive eight daily prompts to view food or non-food related advertisements, and respond to a short 9-question survey for 7 days, * answer several questionnaires, * and complete two in-person visits to complete a virtual reality food selection task.

The goal of this clinical trial is to test whether an adaptation of an evidence-based, couple-based preventive intervention at the transition to parenthood improves reduces obesity risk among infants and parents in military families via improved interparental support and coordination around health lifestyle behaviors and parenting. The main question it aims to answer is whether an adapted, innovative family-focused approach to obesity prevention can reduce rapid infant weight gain, new mothers' postpartum weight retention, and fathers' weight status. Participants randomized to the Healthy Family Foundations (HFF) intervention condition will participate in 10 online group classes (5 prenatal and 5 postnatal). Participants randomized to the control condition will receive standard of care and opportunities for education at their site. Researchers will compare the Healthy Family Foundations (HFF) intervention group with a Standard of Care control group to see if there are differences in weight, coparenting support, parent mental health and parent health behaviors.

The purpose of this study is to evaluate the effectiveness of the Thrive Initiative's parent-education program delivery methods by comparing hybrid (i.e., a combination of online and group components) program delivery to online-only program delivery. The Thrive Initiative consists of four, universal parent-education programs that correpsond to specific child developmental periods. These programs inlcude: Take Root for parents/caregivers of 0-3-year-old children; Sprout for parents/caregivers of 3-5-year-old children; Grow for parents/caregivres of 5-10-year-old children; and Branch Out for parents/caregivers of 10-18-year-old children. The effectiveness of delivery method will be examined for each program. Eligible participants for this study will be United States Air Force service members or dependents who are caregivers of a child 0-18 years old. The study will involve randomization to condition meaning that participants will be assigned to the online-only or hybrid program delivery condition by chance.

The purpose of this research study is to determine if a healthy Mediterranean diet containing one medium potato/day has equivalent or non-different effects on risk factors for type 2 diabetes and heart disease compared to a healthy Mediterranean diet without potatoes in adults with prediabetes. Participants will be randomly assigned to one of the test diets and be asked to consume this diet for 12 weeks (84 days). Testing will be conducted at the beginning and end of the study.

This pilot study evaluates the feasibility, acceptability, and preliminary effectiveness of Lion Hearts, a community-based, family-centered physical activity intervention designed to improve cardiovascular health among mother-child dyads. Developed through community co-design, the 12-week intervention is delivered in local CrossFit affiliates and includes twice-weekly fitness sessions incorporating functional movement, goal setting, teamwork, and health education. The study aims to assess changes in physical activity, fitness, and cardiovascular health markers, as well as family dynamics and motivation for physical activity. Participants complete baseline, mid-, post-, and 3-month follow-up assessments, including surveys, fitness testing, accelerometry, and optional lab work. Findings will inform the refinement of the intervention for future large-scale trials.

The goal of this clinical trial is to learn about the effect of communicative interaction on verbal communication in people with amyotrophic lateral sclerosis (ALS) and their caregivers. The question is, What are the effects of communicative interaction on verbal communication in people with ALS when they interact with their caregivers and does this change over time? Participants will read words and sentences while they are interacting with their caregivers.

This study looks at whether using secure digital systems to share information between pediatric health care providers (during regular well-child visits) and social care providers (during regular visits with WIC nutritionists) can help mothers receive consistent guidance on responsive parenting to support healthy child growth and development. Responsive parenting means learning how to respond to a baby's needs in ways that support healthy eating, sleep, activity, and emotion regulation habits. The main questions this study aims to answer are: 1. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting to support healthy growth from birth to 24 months? 2. Does using secure digital systems to share information between pediatric health care providers and social care providers help mothers receive consistent guidance on responsive parenting, improve responsive parenting practices and child diet quality? The investigators will compare the group that receives secure digital systems for sharing information on responsive parenting to a group that receives standard care (does not receive this) to see if secure digital systems for sharing information on responsive parenting work to support healthy child growth and development. The goal is to see if this approach can improve early health behaviors and reduce health disparities for families in rural, low-income communities.

Increased availability of high-energy dense foods has contributed to a pediatric obesity epidemic, with 23% of United States children currently presenting with the disease. How children eat contributes to both overconsumption and greater adiposity. However, it is unclear if laboratory measures of children's eating style generalize to the home environment, where children consume two thirds of their total energy. The study will 1) test if child eating styles observed in the lab generalize to more ecologically valid home environments and 2) identify aspects of home food environment that amplify obesogenic eating behaviors. We will assess laboratory and home eating styles (e.g., bite rate) in 100 prepubertal 6-9-year-old children to constrain variability in energy requirements. Children will be video-recorded while consuming identical study-provided meals at home and in the laboratory (counter-balanced order) in addition to a 'typical' meal at home. To study how adiposity relates to "obesogenic" styles of eating, gold standard dual x-ray absorptiometry will be used.

The goal of this clinical trial is to learn if an 8-week, community-based pickleball program can improve sensory-motor function and reduce the severity of core autism symptoms in adults ages 18-45 with autism spectrum disorder (ASD) who can participate independently without a caregiver. The main questions it aims to answer are: 1. Does participating in the pickleball program improve sensory-motor function (including visual-motor integration and proprioceptive bias), measured using the HaptiKart task and a pickleball skill assessment? 2. Does participating in the pickleball program reduce core autism symptom severity, measured by the Social Responsiveness Scale, 2nd edition (SRS-2)? Researchers will compare an early-start pickleball group to a delayed-start control group (who continues usual activities at first) to see if the pickleball program leads to greater improvements in sensory-motor outcomes and ASD symptom severity. Participants will: * Complete an in-person baseline visit at a local public library to provide written consent, complete surveys (SRS-2, PROMIS Depression and Sleep measures, and WHOQOL-BREF), and complete a video game-based sensory-motor assessment (HaptiKart). * Be randomly assigned to either start pickleball classes immediately or after an initial delay period. * Attend pickleball classes twice per week for 8 weeks (90 minutes per class; 16 sessions total), led by trained instructors at community indoor court facilities. * Continue their usual activities during periods when they are not assigned to pickleball classes. * Complete a brief pickleball skill assessment during the intervention period at their first and last class. * Complete follow-up assessments after each phase of the study to repeat surveys and sensory-motor testing. * Participants will also wear a small activity monitor (ActiGraph) during pickleball sessions to measure in-class physical activity levels, and complete brief online check-ins about safety/injury and program feedback during the intervention period.

The goal of this step-wedge trial is to test the implementation of daily nurse screening for delirium in routine care and its impact on outcomes and complications in hospitalized older adults admitted to 6 general medicine/surgery units at 3 hospitals in Pennsylvania and Massachusetts. The main question\[s\] it aims to answer are: * 1\. To test the fidelity, accuracy, and durability of implementing daily nurse screening for delirium using the UB-CAM in routine care. * 2\. To evaluate the impact of UB-CAM delirium screening on patient and care partner centered outcomes assessed at one month follow-up interviews 3. To evaluate the impact of UB-CAM screening on rates of delirium complications (falls, pressure injury, aspiration) and adverse delirium management (psychoactive medication use, restraint use). Participants (patients) will be assessed for delirium on study days 1, 2 and 3 (or until hospital discharge) and will be asked basic demographics. These patients will be contacted by phone 1 month after enrollment to collect information about inpatient facility use and to administer the Delirium Burden Patient Scale. Participants (care partners) will be interviewed at the patient's discharge to complete the Alzheimer's Disease-8 scale. These care partners will be contacted by phone 1 month after enrollment to complete the Delirium Burden Caregiver Scale and to complete a Qualitative Interview which includes questions about communication and collaboration.

In this study, we will evaluate how solo, naive listeners perceive the speech of people with amyotrophic lateral sclerosis (ALS) and age-matched speakers produced across interactive and non-interactive contexts with an unfamiliar, naive interlocutor.

The goal of this clinical trial is to assess the program's impact on parent self-efficacy and co-parental support around (a) accessing health and educational services and (b) parenting for co-parents of children with disabilities entering the Special Education system before their first Individualized Education Program (IEP) meeting. The main questions it aims to answer are: Does the program improve co-parenting support and coordination and parent efficacy in accessing services for and parenting their child? Does the program improve parent mental health, service access, engagement, and adherence? Does the program improve parenting quality? Does the program improve child adjustment (mental and behavioral health, academic engagement)? Researchers will compare pretest and posttest questionnaires from Treatment Group A with Control Group B to see if the program improves parent and child well-being, co-parenting relations, relations with service providers, ability to access services and meaningfully participate in IEP and other meetings. Participants will: * Complete pre- and post-test questionnaires * Treatment Group A will participate in 6 learning sessions, each 1 hour to 1½ hour long, over a 6-8 week period

Dietary interventions of prune consumption during the transmenopausal period are innovative methods to prevent bone loss. Modern medicine does not intervene to prevent or attenuate this highly vulnerable period of bone loss which, if successfully attenuated, can potentially prevent/delay osteoporosis in women. The transmenopausal period represents an opportunistic window for the study because bone loss is at its greatest at this time, with females losing as much as 6-7% of bone. If this project is successful at attenuating bone loss, it can immediately be disseminated to the public to promote prune consumption to slow down and attenuate perimenopausal bone loss. As such, this project could improve the long-term bone health of females and avoid or delay osteoporosis and improve quality of life. The long-term goal of this study is to test the novel hypothesis that prune consumption for 18 months during the 3-year transmenopausal period prevents the dramatic rate of bone loss in perimenopausal females during a window of heightened physiological vulnerability. At Penn State University, the study will compare the effects of 18 months of daily dietary consumption of 50 g of prunes (5-6) versus a no-prune control group on bone outcomes (bone mineral density, bone geometry), mechanistic factors (bone and inflammatory markers, inflammatory response of ex vivo cultured peripheral blood mononuclear cells, monocytes), and gut microbiome.

The purpose of this study is to determine if, compared to non-depressed adults, differences exist in skin blood flow and sweating responses to passive heat stress in adults with clinically diagnosed depression, those with depression who are prescribed and taking SSRIs and those with depression who are prescribed and taking SNRIs.

This study will examine the effect of a healthy diet containing cottonseed oil compared to healthy diets containing other commonly consumed plant oils on biomarkers of heart and metabolic health after 4 weeks.

The goal of this clinical trial is to determine whether adding Integrated Decoding and Encoding instruction to the ALLSTAR literacy program improves reading outcomes for students with significant literacy and communication needs. The study will also examine how students' reading skills change over time across instructional conditions. The main questions it aims to answer are: Do students who receive ALLSTAR with Integrated Decoding and Encoding instruction demonstrate greater improvements in literacy outcomes than students who receive ALLSTAR as standard care alone? How do students' literacy skills change from baseline to mid-intervention and post-intervention across the two instructional conditions? Researchers will compare two groups using a randomized controlled trial design. One group will receive 60 lessons of ALLSTAR as the standard of care (ALLSTAR-SC), and the other group will receive 60 lessons of ALLSTAR with the addition of Integrated Decoding and Encoding lessons (ALLSTAR-I\*). Literacy outcomes will be measured using repeated assessment probes at baseline (0 Lessons), after 30-40 lessons, and after 60 lessons to evaluate differences between groups and changes over time in the individuals.