Clinical trials

This study will evaluate Strong as a Mother, an existing community exercise program for women returning to exercise after childbirth. The goal is to determine whether the program can be delivered consistently, whether participants find it acceptable, and how it may affect fitness and physical function. Approximately 30 medically cleared women who are 3-12 months postpartum will be randomly assigned to begin the program immediately or continue their usual activities for 12 weeks before being offered the program. The program includes three supervised sessions per week combining strength training, aerobic exercise, and breathing and bracing instruction. Exercises will be adjusted to participants' abilities and symptoms. Assessments will occur before and after the 12-week period, with a brief check-in at six weeks. Researchers will measure participation, program delivery, and adverse events, along with aerobic fitness, grip strength, and lifting, carrying, and chair-rise performance. Additional assessments will examine abdominal-wall characteristics, maternal functioning, postpartum quality of life, and pelvic-floor symptoms. This pilot study will provide preliminary findings to refine the program and plan a larger trial.

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 study is to examine whether an evening snack of 1 oz of walnuts consumed in place of usual evening snacks for 4 weeks has a beneficial effect on diet quality and sleep quality in adolescents age 13-17 years.

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.

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 goal of this clinical trial is to assess the effects of passive calf muscle stretching in patients diagnosed with peripheral artery disease (PAD). The main question it aims to answer are: 1. To determine if daily calf muscle stretching at home improves calf muscle and vascular health. 2. To determine if daily calf muscle stretching at home improves walking performance. Participants will use inflatable ankle splints for 30 minutes a day, 5 days a week for 4-weeks on both days and 4-weeks of no stretching.

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.

The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are: * Does AIM-CBCT for PTSD improve PTSD symptoms? * Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction? Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.

The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services. The aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological "risk" and recalibration. Cohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles

The Parent Responsiveness Optimized: Growth, Regulation, Eating, Sleep, and Soothing (PROGRESS) study is a randomized clinical trial designed to prevent early childhood overweight among rural, low-income families participating in the Pennsylvania Special Supplemental Nutrition Program for Women, Infants, and Children (PA WIC). The study will enroll 328 first-time mother-infant dyads, with infants having a birthweight at or above the 50th percentile, and follow families from infancy through age 2 years. All participants will receive responsive feeding education through WIC as part of standard care. In addition, the study will test three telehealth-delivered responsive parenting intervention components: (1) sleep-soothe-play guidance, (2) parent-child communication support using infant signing, and (3) parental mindfulness training. Using the Multiphase Optimization Strategy (MOST) framework (a 2 × 2 × 2 factorial design), participants will be randomly assigned to one of eight conditions representing different combinations of these intervention components. Participants not receiving a specific intervention component will receive a safety education curriculum. This approach allows investigators to evaluate the individual and combined effects of each intervention component and identify the most effective and efficient intervention package. The purpose of the study is to determine which responsive parenting components, alone or in combination, are most effective in reducing the risk of overweight and promoting healthy growth during early childhood. The primary outcome is overweight at age 24 months, defined as body mass index (BMI) at or above the 85th percentile for age and sex at 24 months. Secondary weight outcomes include BMI trajectory over 24 months, BMI z-score at 24 months, conditional weight gain from birth to 6 months, growth from 6-24 months, and obesity (BMI at or above 95th percentile for age and sex) at 24 months. Additional outcomes include responsive parenting practices, parent-child communication, parental mindfulness, and implementation outcomes such as intervention fidelity, adherence, acceptability, and participant satisfaction. Findings from this study may help identify scalable, evidence-based strategies for preventing early childhood overweight in rural, low-income populations and support future integration of optimized responsive parenting interventions within WIC and other community-based services.

The main objective of this project is to demonstrate the potential of three new technical innovations for improving state-of-the-art bronchoscopy guidance systems. Through this study, we plan to generate preliminary data that demonstrates the potential of three new innovations for enhancing existing bronchoscopy systems in the live clinical setting. The goal is to demonstrate the potential of the new innovations: 1. to demonstrate the potential of a new methodology to reduce errors from CT-to-body divergence in the live clinical setting, 2. to demonstrate the potential of the new methodologies to enable live rerouting of a guided bronchoscopy, and 3. to perform automatic real-time mucosal lesion detection during a standard airway examination. These innovations could potentially improve current image-guided bronchoscopy systems and be used for future robotic bronchoscopy.

Healthy foods, including peanuts, may improve brain function, which is essential for cognitive and metabolic health, and may contribute to improved food intake regulation. It is therefore important to investigate the specific effects of peanut butter on cerebral blood flow responses, as well as the potential associated functional benefits. The researchers hypothesize that long-term peanut butter consumption improves vascular function in the brain, thereby enhancing cognitive performance and appetite control in middle aged and older adults. Objective: The primary objectives are to investigate in middle aged and older men and women the effect of 16-week peanut butter consumption on brain vascular function, while we will also assess changes in cognitive performance and appetite-related brain reward activity (secondary objectives). Cerebral blood flow responses (brain vascular function) will be non-invasively quantified by the non-invasive gold standard magnetic resonance imaging (MRI)-perfusion method Arterial Spin Labeling (ASL).Study design: This intervention study will have a randomized, controlled, cross-over design. The total study duration will be 40 weeks, including two 16-week interventions, separated by a washout period of at least 8 weeks. Study population: Forty-five middle-aged and older men and women (aged 45-75 years) without a history of cardiovascular diseases or complaints will participate. This population is expected to have a decreased cerebral blood flow at baseline and are also at increased risk of cognitive impairment, allowing for improvement by the intervention. Intervention: Study participants will receive, in random order, 45 g of peanut butter daily (peanut intervention) or no peanut butter (control) for a total of 16 weeks, separated by a wash-out period of at least 8 weeks. Main study parameters/endpoints: At baseline, first anthropometric measurements will be performed and blood pressure will be determined. In addition, a fasting blood sample will be drawn. Another fasting blood sample will be drawn at eight weeks, while participants have to attend the research facilities to perform follow-up measurements after sixteen weeks. The primary endpoint is the difference at follow-up in the cerebral blood flow response between peanut butter intervention and control periods. Cognitive performance will be assessed, while the researchers will also focus on appetite-related brain reward activity (secondary outcomes).

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 age-matched speakers. The question is, What are the effects of communicative interaction on verbal communication in people with ALS? Participants will read words and sentences while they are in a solo setting and interactive setting.

The purpose of this study is to better understand the underlying mechanisms associated with elevated cardiovascular disease risk in women with endometriosis, and to measure the effectiveness of emerging endometriosis treatments on outcomes specific to cardiovascular dysfunction. Epidemiologic data demonstrate a clear association between endometriosis, reproductive risk factors, inflammation and cardiovascular (CV) risk. Circulating factors, low-density lipoprotein (LDL) and oxidized LDL (oxLDL), are two of many biomarkers of cardiovascular and inflammatory disease of endometriosis. An important signaling mechanism through which circulating LDL and oxLDL act is the lectin-like oxidized LDL receptor (LOX-1). LOX-1 signal transduction functionally results in pronounced endothelial dysfunction, a hallmark of CV. The investigators hypothesis that one factor mediating the elevated risk of cardiovascular disease in endometriosis is systemic inflammation and activation of LOX-1 receptor mechanisms.

The purpose of this study is to look at the effect of consuming peanut butter at breakfast on blood sugar control, cognitive function, and heart disease risk factors in middle-aged adults with prediabetes.

The goal of this clinical trial is to learn about the effects of consuming fermented pulses (certain types of legumes like chickpeas or lentils) in healthy people. The main questions it aims to answer are: 1. How does consuming the fermented foods impact the gut microbiome? 2. Does this interaction between the fermented foods and the gut microbiome affect inflammation? Participants will be asked to consume two sets of prepared meals, one containing unfermented pulses, the other containing fermented pulses. Researchers will compare the gut microbiome and inflammation between these two diets.

The goal of the study is to examine alcohol use behaviors of young adults through the use of testing the feasibility of adding an innovative brief personalized alcohol biomarker feedback component (TAC feedback) to an existing efficacious personalized feedback intervention, eCHECKUP TO GO (eCTG), and how (if at all) the intervention impacts drinking behaviors in high-risk college students. The study will conduct a feasibility assessment of the TAC feedback component, and will also assess the effects of the eCTG + TAC at 6-months post-baseline relative to an eCTG only group.

The purpose of the study is to assess precision of the GE Lunar iDXA, Hologic Horizon W DXA scanner, and the Stratec peripheral quantitative computed tomography (pQCT) scanner. Aim 1: To assess standard deviation (SD) and coefficient of variation (CV) of testing bone mineral, bone geometry, and soft tissues in inanimate objects and adults. Tests on adults will be structured to assess: 1. Within- and between-day variability of testing 2. Within- and between-technician variability of testing 3. Variability due to positioning and post-scan processing 4. Variability due to different DXA scanning equipment Aim 2: To assess the least significant change (LSC) for testing bone mineral and soft tissues in adults. Aim 3: To assess strengths and limitations of DXA and pQCT testing, including sensitivity to movement, rate of re-rescanning, etc. which are crucial components for demonstrating feasibility in grant applications. Aim 4: To construct a database of DXA and pQCT test results and quality control procedures, showing our laboratory's quality control level.

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 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.

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.