Clinical trials

The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.

Early Intervention (EI) systems are ill-equipped to serve the many children 12 to 36 months with early signs or a diagnosis of autism spectrum disorder (ASD). EI funded by Part C of the Individuals with Disabilities Education Act (IDEA) uses home-based service delivery, emphasizes family-centered care, and prioritizes family-defined concerns (i.e., patient-centered outcomes). The Part C system is ideally situated to provide family-based intervention to children aged birth to three. However, Part C EI providers receive little training in ASD or the challenges characterizing ASD in toddlerhood, most notably emotion regulation. This study introduces Parent Training for emotion regulation for autistic toddlers into the Part C EI system, determines its feasibility and preliminary efficacy in this setting, and assesses what family, provider, and system-level factors may facilitate the uptake of parent training in the Part C EI system.

Mindful walking is a promising and practical strategy because it combines two activities known to support healthy aging: walking and mindfulness. Unlike many structured exercise programs, mindful walking is low intensity, accessible, and easier to sustain in daily life. It may be especially useful for older adults at elevated risk for ADRD. However, most existing mindful walking studies have focused on mental health outcomes, such as stress reduction, rather than cognitive health. Little is known about whether mindful walking can support cognition or how it may influence brain function. To address this gap and strengthen a future R01 resubmission, the investigators propose a two-arm randomized controlled pilot trial using functional near-infrared spectroscopy (fNIRS), a safe, non-invasive brain imaging method. fNIRS measures brain activity through sensors placed on the scalp and is well-suited for repeated assessments in older adults because it is quiet, portable, painless, and cost-effective. The investigators will recruit racially and ethnically diverse middle-aged and older adults from the Midlands of South Carolina who are at elevated risk for ADRD. Participants will be randomly assigned to one of two groups: mindful walking or walking-only control. Both groups will complete 8 staff-supervised individual sessions over 4 weeks. The mindful walking group will learn and practice simple mindfulness skills while walking in multiple settings, including lab-based, indoor, and outdoor environments, to support real-world use. Findings from this pilot study will provide important evidence on whether mindful walking can support brain and cognitive health in adults at elevated risk for ADRD. The results will also help establish a practical, scalable, and sustainable prevention strategy for underserved aging populations in South Carolina.

The goal of this cluster-randomized type 1 effectiveness implementation hybrid trial is to evaluate whether a community health worker led, integrated digital health intervention (Huduma Kwa Wakati; "Timely Services" in Kiswahili) can improve rates of timely well visits and receipt of key recommended preventive interventions among children in their first year of life. The hypothesis is that Huduma Kwa Wakati will improve the timeliness and rates of completion of child well visits and receipt of recommended preventive services before age 1 year, compared to the standard of care. Researchers will compare outcomes among children enrolled from intervention clusters and no-intervention comparison clusters. Outcomes will also be compared to a cross-sectional retrospective comparison sample. This study will address the lack of rigorous evidence on the effectiveness of a community-based digital health intervention for promoting rates and timeliness of preventive service receipt among children from sub-Saharan Africa, and identify implementation strategies to facilitate the deployment of integrated community-based digital health interventions in low- and middle-income country settings.

Studies show that preschool-age children are especially vulnerable to accelerated weight gain during the summer, with those from low-income households (≤185% poverty level or Medicaid eligible - the target population for this study) exhibiting the greatest risk of unhealthy weight gain. Despite numerous interventions designed to prevent OWOB, none target preschoolers during summer. For families from low-income households, attending center-based childcare is associated with a lower risk of developing OWOB by 1st grade compared to attending home-based care. Center-based childcare lowers the risk of OWOB through daily rules/routines that promote healthy behaviors. For families from low-income households, publicly funded center-based childcares (e.g., needs-based pre-K, Head Start) typically operate on an academic/school 9-month calendar (Aug-May). During summer, fewer than 30% of preschoolers attend center-based childcare. For many preschoolers from lower-income households, summer may serve as an extended period away from formal center-based childcare, because the out-of-pocket expense may prohibit attendance. This may promote unhealthy behaviors and excessive weight gain. In the majority of US states, publicly funded center-based childcare during the academic/school year for families from underserved populations is free; however, center-based childcare during the summer is an out-of-pocket expense for many of these families. Despite parents' desire for childcare during the summer, a major reason children from low-income households do not attend center-based care during summer is cost. This creates unequal access to resources and likely exacerbates health disparities for families from low-income households. Using a structural intervention approach, this study will test the impact of providing free center-based childcare in the summer. This R01 will rigorously test the impact of providing free center-based childcare during the summer on weight status of preschoolers from low-income households (≤185% of poverty level or Medicaid eligible).

Youth living with HIV (YLHIV) face barriers to engagement and retention in HIV care, show poor medication adherence, and often fail to achieve and maintain viral suppression. YLHIV in the southern United States have particularly poor care engagement outcomes. South Carolina is one of nine states identified as "key drivers" of the US HIV epidemic, and HIV rates for youth in South Carolina have risen in recent years. Tailored interventions are urgently needed to improve outcomes for this population. One promising approach is to reach YLHIV via mobile Health (mHealth) technology, yet few efforts have sought to tailor mHealth interventions to the needs of YLHIV in the southern US. Thus, the scientific objective of this study is to pilot test a new mHealth intervention, called MindBodyU, designed to increase engagement/retention in care and ART adherence among YLHIV in South Carolina. In this study, investigators will evaluate the feasibility, acceptability, and initial efficacy of the mHealth intervention with a six-month pilot trial with 40 YLHIV in South Carolina.

The goal of this clinical trial is to test a twice a week, moderate intensity exercise and coaching program (an in-person group and a distance group) for adults with mild-moderate cognitive impairments living in South Carolina. The main questions it aims to answer are: 1. Is the program practical to conduct, and it is acceptable and enjoyable? The hypothesis is that it will be possible to recruit participants, obtain the desired dosage of moderate intensity fitness and strength training twice a week for both groups. 2. Are their changes at 3, 6, 9 and 12 months in endurance, mobility, cognitive function and perception of cognitive function? The hypotheses are that endurance, strength and mobility will improve and cognitive measures will not decline (remain the same or improve) for both groups.

This project aims to tailor repetitive Transcranial Magnetic Stimulation (rTMS) target to the clinical profile of post-stroke aphasia, specifically focusing on lexicosemantic impairments, to enhance recovery. Functional Magnetic Resonance Imaging (fMRI) will provide critical insights into the effects of facilitatory versus inhibitory stimulation on interhemispheric balance. Additionally, this study will generate new data on how lesion localization and brain connectivity influence individual responses to rTMS, explaining variability in treatment efficacy.

The purpose of this study is to identify which supplemental intervention components added to an online exercise program contribute to the greatest increases in physical activity (total MVPA and percent meeting guidelines \[≥150 min/week of MVPA\]) in adults with knee replacement at 6 and 12 months. Secondary outcomes will examine changes in pain and physical function.

The goal of this clinical trial is to find out whether an enhanced program works better than remote blood pressure monitoring (RBPM) alone for women who had high blood pressure during pregnancy. The enhanced program combines RBPM with a lifestyle program led by a community health worker (CHW). The study will examine whether the enhanced program helps women better control their blood pressure, lowers their average resting blood pressure, improves heart health risk factors (such as weight, diet, physical activity), supports mental well-being, and reduces emergency department visits and hospital readmissions by 6 months after delivery.

The purpose of the study is to see examine the effects of 3 different levels of physical activity (45 minutes/week, 90 minutes/week, or 150 minutes/week) on arthritis symptoms.

Speech-language therapy is generally found to be helpful in the rehabilitation of aphasia. However, not all patients with aphasia have access to adequate treatment to maximize their recovery. The goal of this project is to compare the efficacy of telerehabilitation or Aphasia Remote Therapy (ART) to the more traditional In-Clinic Therapy (I-CT).

A public health priority exists for the U.S. healthcare sector to integrate physical activity (PA) as a part of the patient care model. This research will provide valuable information on facilitating optimal implementation of a clinic-to-community model that identifies, refers, and enrolls physically inactive patients to community-based PA programs for the prevention and treatment of chronic diseases. Further, this work will provide evidence on the cost-effectiveness of integrating PA in healthcare systems as a population health management strategy.

This study aims to evaluate whether early childhood development is improved by a bundled set of interventions that promote responsive stimulation and improved nutrition by the provision of eggs and dried fish (nutrient-dense animal source foods), and whether, in combination, these stimulation and nutrition interventions are more effective than responsive stimulation or food provision alone.

Brief Summary The purposes of this study are to develop and implement a peer-led intervention program on Instagram for promoting prescription opioid use management and fostering psychosocial skills among young adults who engage in non-medical use of prescription opioids in the United State. The specific aims of the study include: (1) To implement and test the feasibility of the 12-week peer-led intervention modules on Instagram among young adults who are randomly assigned to either receive the intervention (intervention group) or not receive the intervention (control group) Participants who are assigned to the intervention group will be paired with a peer leader and attend to peer-guided interactive modules on Instagram over 12 weeks. They will complete an online survey at 1st week and 12th week, as well as brief evening surveys every two days during the intervention. The control group will not take part in intervention activities but will complete an online survey at 1st week and 12th week.

This study is a 6-month randomized controlled trail of diet modification designed to reduce chronic inflammation and reverse metabolic dysfunction among obese individuals with one or more polyps found at a colonoscopy screening. We also will recruit an at least overweight partner, who lives in the same household. To be eligible, participants will be apparently disease-free, obese AAs or EAs who have self-identified a partner who is at least 9 years, with whom they live and who also is at least overweight. Each index participant will: 1) Be AA or EA by self-report; 2) Be ≤55 years old; 3) Have undergone a colonoscopy screening and found to have ≥1 polyp(s); 4) Be free of co-morbid conditions or other factors that would limit participation in this trial; 5) Have a BMI ≥30kg/m2; 6) Be willing to commit to investing the time and effort required to participate in this trial (i.e., willing to complete all assessments and provide biological samples as specified in the consent); and 7) Have no recent antibiotic use. Their partner needs to: 1) Be at least 9 years old; 2) Live in the same household and consumes meals together; 3) Be at least overweight; 4) Agree to all study procedures, including provision of biological samples, body measurements, and self-reported dietary and other assessments; and 5) Have no recent antibiotic use.

The purpose of this study is to evaluate the effects of pistachio snacking on metabolic flexibility (at rest, during exercise, and in post-exercise recovery) in healthy overweight and obese adults. Secondary goals include evaluating effects on changes in diet quality, sleep characteristics, physical activity, and hormonal health in women. In randomized order, participants will complete four days of pistachio snacking and four days of normal dietary habits (control). For both conditions, primary outcomes of resting substrate metabolism, metabolic flexibility during exercise, and post-exercise substrate metabolism will be measured pre-post intervention via indirect calorimetry. Secondary outcome of diet quality (kcal, carb, fat, protein) will be measured pre-post intervention via diet log. Exploratory outcomes of daily physical activity (steps, intensity), nightly sleep characteristics (quantity, quality, latency, efficiency), and daytime sleepiness and hunger.

Many effective interventions or programs are never put into practice. This quasi-experimental study will partner with AME churches in two areas of South Carolina to study how an evidence-based program is put into place by the church. The program, Walk Your Heart to Health, will include training in how churches can modify their practices to support physical activity and healthy eating. Over the five-year study, the investgiators will examine factors that predict the success of putting the program into place, things that help and get in the way of putting the program into place, and how the program can be scaled up to reach even more churches. The investigators will also examine the effect of the program (pre- to post-changes) on walking group member outcomes (physical activity and social cohesion). The investigators expect to work with approximately 26 AME churches for this study.

Over 130 million adults in the US experience overweight and obesity, and rural communities experience significantly higher rates of obesity and related chronic diseases. Although lifestyle interventions successfully produce clinically significant weight losses, the availability of weight management programs is limited in rural areas. Digital interventions offer an attractive alternative for delivering lifestyle programs to rural populations. However, in-person behavioral obesity treatment programs achieve better weight losses than digital programs, likely because in-person programs typically include personnel-intensive "high touch" treatment components. Some studies indicate that having a human "behind the curtain" of a digital program through emailed feedback or with the addition of online group sessions can significantly increase weight loss. Therefore, the aims of this study are to increase the public health impact of digital obesity treatment for rural populations by simultaneously investigating 3 "high touch" intervention components. The investigators will conduct a highly efficient experiment with participants residing in non-urban areas recruited online from across the United States. Participants (N=616; 22% racial/ethnic minority; 40% male) will be randomized to: (1) weekly facilitated synchronous group video sessions (yes vs. no); (2) type of self-monitoring feedback received (counselor-crafted vs. pre-scripted); and (3) individual coaching calls (yes vs. no). These components will be layered onto our 24-week evidence-based, interactive digital weight loss program delivered to groups of eligible individuals. Based on the results of the experiment, The investigators will identify an optimized program in which each component (or combination of components) contributes meaningfully (at least 1.5 kg greater weight loss at 6-months) to enhanced weight loss. The investigators will also exploratory analyses of weight trajectories 6-months post-treatment (i.e., at 12-months) to elucidate extended impact of the specific components on weight control. Ultimately, this research will set the stage for confirming the most promising digital behavioral weight loss intervention that can be used without geographic borders to reduce obesity rates among rural residents and provide the evidence needed to establish best practice policies for broadly effective digital approaches to weight control.

The goal of this research is to examine the addition of a digitally delivered social support training approach to an existing digital program designed to promote a physically active lifestyle among self-selected teams of adults who are not meeting physical activity guidelines. The main aims are to: 1. Determine if the social support training intervention promotes significantly greater changes in moderate-to-vigorous intensity aerobic physical activity (such as a brisk walk) as measured by an accelerometer (research grade physical activity measurement device) at 3 months compared to the same intervention without social support training among self-selected teams of adults who are not meeting the physical activity guidelines. 2. Determine if the social support training intervention promotes significantly greater changes in social support, motivation, accountability, and autonomy social support (free from excessive control and encouraging one's free will) at 3 months and 12 months compared to the same intervention without social support training. 3. Determine if the social support training intervention promotes significantly greater changes in moderate-to-vigorous intensity aerobic physical activity as measured by an accelerometer at 12 months compared to the same intervention without social support training. 4. Explore whether social support mediates increased and sustained moderate-to-vigorous intensity aerobic physical activity among the entire sample of participants.

This study tests the efficacy of a dyadic intervention to mitigate the adverse health consequences of severe acute respiratory syndrome coronavirus 2 (SARS- CoV-2 )(COVID-19) in African American (AA) adults with pre-existing chronic health conditions and their informal carepartners (IC). Socioeconomically disadvantaged, older, and Black/African American from rural regions are burdened with greater rates of chronic diseases such as diabetes, hypertension, chronic kidney disease, cardiovascular disease, and stroke.

Investigator will test an intervention to increase use of a fruit and vegetable incentive program in South Carolina for families in the Supplemental Nutrition Assistance Program (SNAP) experiencing food insecurity. Caregivers are randomized to an intervention or an education-only, wait-list control group. The investigators hypothesize the intervention will improve diet-related outcomes, above and beyond the education-only wait-list control.

This study examines the time course of activation of the left anterior temporal lobe (ATL) during lexical processing using Transcranial Magnetic Stimulation (TMS).

Background/significance: Over 100,000 early preterm infants are born annually in the United States and suffer morbidity and mortality during hospitalization in a neonatal intensive care unit. One such condition is hypothermia. Hypothermia has been defined as a contributor of neonatal morbidity by The World Health Organization. Another acute morbidity is anemia in preterm infants due to the prematurity and frequent laboratory testing. Anemia requires correction with a packed red blood cells (PRBC) transfusion. Researchers have previous noted hypothermia during PRBC transfusions in preterm infants. Objective: To use a commercial blood warmer in the neonatal intensive care setting to prevent hypothermic body temperatures (\<36.5°C) in very preterm infants during PRBC transfusions. Process: Based on a completed national survey of neonatal intensive care nurses and PRBC transfusion practices and personal NICU experience, we designed this randomized control trial in 140 very preterm infants in a Southeastern, level III neonatal intensive care unit. Outcomes: Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a lower incidence of central body hypothermia post transfusion (temperatures \<36.5C), compared to infants receiving PRBC transfusions by standard of care. Very preterm infants (\<32 weeks gestational age) receiving PRBC transfusions warmed by the commercial blood warmer will have a higher post transfusion mean abdominal skin body temperature when compared to infants receiving PRBC transfusions by standard of care. Hypothesis : The results of this trial could show that very preterm infants experience hypothermia during PRBC transfusions, and thus provide the evidence to support the need for warmed PRBC transfusions in very preterm infants nationwide.

The goal of this clinical trial is to examine the effects of body tempering on healthy volunteers between the ages of 18-39. The main question it aims to answer is will the intervention have an impact on immediate or 24-hour measures of lower extremity power as measured by the: vertical jump test? standing long jump test? Researchers will compare an alternate intervention of foam rolling self-myofascial release to see if any changes in jump test performance are comparable. Participants will perform a brief warm-up followed by baseline performance of the two jump tests (5 repetitions each). Participants will be randomized into one of two groups: either application of the body tempering intervention or performance of self-myofascial release via foam rolling. Following the intervention, participants will be asked to perform 3 repetitions of each outcome measure (jump test); participants will be asked to return 24 hours later where they will guided through the same warm-up as the day prior and will again perform 5 repetitions of each jump test.