Clinical trials

This is a 12-month, 2-arm randomized controlled trial (n=150) examining whether toddlers randomized at 12 months of age to 1.5 cup-equivalents/day of cow's milk-based dairy versus oat milk-based dairy, and followed to 24 months, have better growth, sleep, neurocognitive, and gut microbiome outcomes.

This randomized remote pilot study will evaluate the feasibility, acceptability, and preliminary effects of two meditation and mindfulness applications among approximately 40 Black women ages 35-64 experiencing moderate to high stress. Participants will be randomly assigned in a 1:1 ratio to Exhale™, a culturally adapted meditation app designed for Black women, or Levelhead, a general mindfulness app. Participants will be asked to complete at least one session using their assigned app per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants will complete online questionnaires at baseline and after the 4-week intervention. Daily Remind messages and weekly study check-ins will support engagement. Outcomes include recruitment, retention, adherence, assessment completion, satisfaction, usability, perceived stress, race-based stress, sleep, depression, anxiety, cultural relevance, and brief participant feedback.

This study investigates the implementation and effectiveness of the Family Check-Up 4 Health (FCU4Health) intervention in primary care settings for reducing cardiovascular disease risk in children. Through a hybrid type 3 cluster randomized factorial trial and innovative technology-based strategies integrated with Electronic Health Records, the study aims to enhance intervention fidelity and engagement. Results will inform scalable approaches to promote child and family health behaviors, improve parenting skills, and potentially reduce child BMI, contributing to significant public health impacts in addressing cardiovascular health disparities.

This pilot study will evaluate a new intervention for parents who are separated or divorced and have been court ordered to participate in a program addressing interparental conflict. The intervention is designed to teach parents skills to reduce children's exposure to conflict between parents and support children's well-being. Participants will be randomly assigned to either the new intervention or an existing court-based program. The study will examine the feasibility, acceptability, appropriateness, and usability of the new intervention and its effects on interparental conflict, parents' use of protective skills, and children's mental health.

The goal of this clinical trial is to learn if a school-based intervention, Operation ToneUp, can improve nutrition knowledge, fitness, and blood pressure in schoolchildren enrolled in grades 3-6. The main questions it aims to answer are: 1. Do students participating in the intervention show improved fitness, measured by upper body strength, core strength, and cardiovascular endurance? 2. Do students participating in the intervention show improved nutrition knowledge, measured by self-report? 3. Do students participating in the intervention show improved blood pressure, measured by blood pressure cuff? Researchers will compare students participating in the intervention to students at comparison schools to see if fitness, nutrition knowledge, and blood pressure differ. Participants in the intervention arm will complete two 20-minute web-based sessions focused on nutrition and fitness during class time. Participants in the comparison arm will not be exposed to Operation ToneUp. All participants will engage in pre- and post- testing including: * PE-teacher assessed push-ups, curl-ups, and PACER test * online self-reported nutrition knowledge assessments * nurse-recorded blood pressure

This project is a pilot trial of the Engaging Families home practice smartphone application (or "app") as an add on to a family-based prevention program. Although there are many evidence-based preventive interventions delivered to caregivers to prevent youth substance use and mental illness and promote youth positive family and youth outcomes, the impact of these interventions is often limited by low home practice of intervention skills among caregivers. The Engaging Families home practice app is a digital behavior change intervention that was developed to support caregivers in practicing intervention skills at home. Researchers will ask participants if the app was acceptable and feasible for daily use at home. Researchers may also compare how often caregivers who use the study app do home practice of intervention skills compared with caregivers who do not receive the home practice app but are encouraged to use an app to help schedule their activities.

This research study will test the effectiveness of a culturally grounded parenting intervention called Parenting in 2 Worlds (P2W). This intervention is designed for American Indian / Alaska Native (AI) parents/guardians of adolescents who reside in urban areas. This will be a multi-regional effectiveness trial across four regions: Northeast (Buffalo/Niagara), Midwest (St. Paul/Minneapolis), Mountain (Denver), and Southwest (Phoenix). There are four specific aims. First, this study will test the effectiveness of Parenting in Two Worlds (P2W) as compared to an informational family health intervention, Healthy Families in 2 Worlds (HF2W), in improving parenting and family functioning. Second, this study will test if the relative effectiveness of P2W, compared to HF2W, varies by parent's/guardian's level of socioeconomic vulnerability, experiences of historical loss, or AI cultural identity. Third, this study will examine if P2W can reduce adolescent (ages 12 - 17) risky health behaviors including substance use, depressive symptoms, suicidality, and risky sexual behaviors. Fourth, this study will examine whether positive changes in parenting and family functioning that result from P2W lead to positive changes in adolescent's health behaviors.

REVIVE is a randomized controlled trial designed to evaluate the effects of a remotely delivered seated Tai Chi/Qigong (TCQ) intervention on cardiometabolic health, stress, sleep, and psychological well-being among women with mobility impairments. Women with mobility impairments experience higher rates of obesity, cardiometabolic disease, chronic stress, sleep disturbances, and mental health concerns compared with women without disabilities. Limited access to accessible physical activity programs and barriers to participation in traditional exercise interventions contribute to these health disparities. Tai Chi and Qigong are gentle mind-body practices that may improve physical and psychological health through movement, breathing, and mindfulness techniques and can be adapted for individuals with limited mobility. Participants will be randomized to either a seated Tai Chi/Qigong intervention or a health education video control condition. During the 12-week intervention phase, participants will receive daily video-based content delivered remotely. Participants assigned to the Tai Chi/Qigong group will engage in seated meditative movement practices, while participants assigned to the control group will receive health and wellness education videos unrelated to physical activity or nutrition behavior change. Outcomes will be assessed remotely at baseline, post-intervention, and follow-up. Primary outcomes include waist circumference and indicators of physiological stress regulation, including heart rate variability and salivary cortisol. Secondary outcomes include perceived stress, emotion regulation, depression, anxiety, emotional eating, sleep quality, and sleep disturbance. Additional measures collected through wearable technology, sleep diaries, questionnaires, and biological samples will be used to examine potential behavioral, psychological, and physiological mechanisms underlying intervention effects. The findings from this study will contribute to the development of accessible, scalable, and evidence-based health promotion interventions designed to improve cardiometabolic health and overall well-being among women with mobility impairments.

Arizona State University is studying how local schools and grocery stores can work together to promote fruits and vegetables and support healthy eating among children and families. The goal of this pilot cluster clinical trial is to determine whether FFVP+, a public private partnership between elementary schools and regional Bashas' Food City stores, can used to support fruit and vegetable promotion among children and their caregivers. The study will include elementary school students and caregivers from elementary schools participating in the USDA Fresh Fruit and Vegetable Program. The main questions it aims to answer are: Can schools and Food City stores coordinate promotion of fruits and vegetables through the FFVP+ partnership? Can we recruit and retain student and caregiver dyads and collect the planned measures across the school year? Do children and caregivers in the FFVP+ schools consume more fruits and vegetables than schools not receiving this enhanced intervention. Researchers will compare schools receiving FFVP+ to schools receiving the usual Fresh Fruit and Vegetable Program only. This will help us understand whether the partnership is feasible, whether the recruitment and data collection procedures work, and whether the approach is ready to be tested in a larger trial. Participants will: Complete study visits at three time points during the school year Complete surveys about fruit and vegetable intake, preferences, household food availability, and shopping practices Have fruit and vegetable intake measured using a non-invasive Veggie Meter device Have height and weight measured Students will also have fruit and vegetable intake measured during school lunch using plate waste methods.

The purpose of this study is to test a culturally tailored, smartphone-delivered intervention designed to increase physical activity and reduce risk for heart disease and type 2 diabetes among African American women.

This project extends the investigators' previous research regarding the intersecting risks of alcohol, sexual risk behavior (SRB), and sexual aggression (SA) in male drinkers who have sex with women by examining the mediating and moderating roles of both intrapersonal and interpersonal emotional factors. While independent streams of research consistently document alcohol's role in SRB and SA, the investigators' work has demonstrated that these behaviors are related, and that alcohol exacerbates their likelihood both independently and synergistically. The researchers' investigations focus on a particular type of SRB: men's resistance to condom use with female partners who want to have protected sex. Condom use resistance (CUR) is common and normative among young male drinkers, with up to 80% of men reporting engaging in CUR. Of particular concern, research demonstrates that up to 42% of men report using coercive CUR tactics such as emotional manipulation, deception, condom sabotage, and force to obtain unprotected sex. Investigators will evaluate hypotheses that distal and proximal emotional and alcohol factors influence in-the-moment SRB/CUR intentions as well as daily alcohol use and SRB/CUR. The investigators will also examine whether the relationships among assessed variables are similar across experimental and naturalistic settings. That is, investigate the extent to which men's responses in the lab parallel their real-world drinking and SRB/CUR behaviors, particularly regarding self and partner emotions, empathy, and interpersonal stress.

Engaging in regular physical activity during midlife is a key lifestyle behavior associated with reduced risk for Alzheimer's disease and related dementias (AD/ADRD). Yet nearly half of midlife adults (48%) do not meet national physical activity guidelines. The purpose of this mechanistic trial is to identify effective goal setting techniques to enhance psychosocial processes of self-regulation for the successful promotion of PA and adherence to national PA guidelines among midlife adults, with the long-term goal of reducing AD/ADRD risk

The aim of this research is to develop protocols that selectively target and improve speech-motor learning processes. Participants will be asked to name pictures, read words/sentences, and listen to sounds while their speech signals will be collected during the study.

The goal of this clinical trial is to learn the effects of technology enhancements when combined with basic education, goal-setting, and self-monitoring to increase physical activity among older adults living alone, experiencing subjective cognitive decline, and currently engaging minimal physical activity (60 minutes or less of moderate to vigorous physical activity). Further, we will examine key psychosocial mechanisms believed to contribute to successful promotion of physical activity, which include social support and stress resilience. The primary questions are to determine whether * the tech-enhanced condition lead to greater physical activity over time? * the tech-enhanced condition lead to social support and stress resilience over time? * social support and stress resilience mediate the relationship between the study condition and physical activity? All participants will engage in self-monitoring of physical activity, will receive weekly text reminders of their physical activity goals for the week, and will receive basic education about the importance of physical activity, social support, and stress resilience for cognitive, physical, and psychological health. Participants in the tech-enhanced condition will also receive access to a study-specific website and virtual coaching to reinforce the information presented. Researchers will then compare the tech-enhanced condition to the basic education condition to determine the benefits of technology to deliver the intervention materials in order to increase physical activity, social support, and stress resilience. Participants will: * Use a Garmin wearable device to monitor their physical activity * Be randomly assigned to a basic education condition or tech-enhanced condition * Set achievable goals for weekly physical activity, with incremental increases to achieve 7000 average daily steps by the end of the study * Respond to surveys to monitor their social support, stress resilience, quality of life, and depression. The sample has several risk factors for Alzheimer's disease and related dementias: low physical activity, social isolation risk via living alone, and subjective cognitive impairment. Therefore, a long-term goal includes the determination of the intervention's effectiveness at increasing physical activity, social support, and stress resilience to reduce risk for developing dementia.

The aim of the present study is to evaluate the effectiveness of a milk permeate-based sports drink on hydration, carbohydrate oxidation, exercise performance, vigilance, and reaction time in the heat. We anticipate that the milk permeate, with 44 g per liter and high sodium and potassium, will lead to better hydration, energy delivery, and physical and cognitive performance.

Heart rate variability (HRV) is a key indicator of fitness, and stress resilience. Previous research has shown that HRV decreases under mental workload, including during tasks that require strict attention. Studies also show that temperature exposure affects attention: cold increases the stress response while warm water has a calming effect. Very few studies combine thermal exposure with cognitive testing, and no controlled trials have investigated whether water temperature modulates HRV responses specifically during cognitive demand.

College students face substantial and persistent mental health challenges that directly affect cognitive performance, stress regulation, and emotional well-being. Neurological functions such as working memory, attention regulation, executive control, and emotional processing are highly sensitive to stressors, leaving young adults vulnerable to daily fluctuations in cognitive efficiency. Recent findings from the Healthy Minds Network (2025) indicate that although rates of moderate to severe depression among college students declined from 44% in 2022 to 37% in 2025, and anxiety symptoms fell from 37% to 32%, levels of psychological flourishing also dropped, falling to 36% despite these improvements. Ginseng contains bioactive compounds known as ginsenosides that favorably influence brain function and inflammatory cascades. Studies in stressed and moderately stressed adults demonstrated reduced perceived stress, improved emotional processing, enhanced cognitive performance, and beneficial changes to biomarkers with ginseng supplementation. In addition, randomized controlled trials reported improvements in mood regulation, fatigue resistance, and aspects of working memory and attention following short-term ginseng supplementation. This study will examine the effects of daily red panax ginseng supplementation (3000 mg/day; two 1500 mg Red Panax gummies) on cognitive performance and emotional well-being in healthy young adults.

A positive impact of a fermented dairy protein with prebiotic fiber supplement on self-reported GI complaints and wellbeing has been suggested (Wardenaar et al. 2024). The following project aims to further investigate the impact of this supplements in athletes with and without GI complaints in two separate data collections. Part I of the data collection aims to investigate the impact of this supplement vs. a placebo on carbohydrate malabsorption (as a potential cause for GI distress) in athletes that normally don't identify as having GI complaints (randomized double-blind cross over study design covering a total of 9 weeks, including a 3-week washout period). Part II of the data collection aims to confirm the earlier found results in the previous study (Wardenaar et al. 2024) in a group athletes self-reporting GI complaints that will be randomized into an intervention group or a placebo group (randomized double-blind parallel study design covering a total of 3 weeks).

The proposed study will test whether neurofeedback (NF) could optimize integrative body-mind training (IBMT) practice.

The goal of this clinical trial is to test 6 months of aerobic exercise in older adults who are 65 years or older and have mild cognitive impairment (MCI) or probable/possible mild Alzheimer's Disease. The main questions it aims to answer are: * test the effects of aerobic exercise on aerobic fitness, white matter hyperintensity (WMH) volume, and patient-centered outcomes; * identify the best exercise to improve aerobic fitness and reduce non-responses over 6 months; and * examines the mechanisms of aerobic exercise's action on memory in older adults with early AD. Participants will receive 6 months of supervised exercise, undergo cognitive data collection and exercise testing 5 times over a year span, have an MRI brain scan 3 times over a one-year span, and have monthly follow-up discussions on health and wellness.

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

The purpose of this study is to examine the relationship between daily light exposure patterns, sleep quality, and migraine characteristics in adults with migraine, with and without photophobia, across an 8-week study period.

This study aims to understand how participating in the Western States Endurance Run (WSER), a 100-mile ultramarathon, affects kidney health. Long, strenuous exercise in hot conditions can temporarily strain the kidneys, especially when combined with dehydration, muscle breakdown, and the use of common pain-relief medications such as ibuprofen. Although kidney stress has been reported in endurance sports, no study has examined it directly in runners during the WSER using newer, more sensitive urine markers of kidney injury. Runners who volunteer will complete brief assessments before and after the race. These include providing a urine sample, a small finger-prick blood sample, a body-weight measurement, and answering a short questionnaire about pain-medication use. During the race, participants will wear a global positioning system (GPS) watch and heart-rate strap to monitor effort. Each assessment takes about 15 minutes, and no follow-up is required. Findings from this study will help determine how often kidney stress occurs in this event and what factors may contribute to it, ultimately supporting safer training and medical practices for ultramarathon athletes.

EPICLA+ (Early-Stage Partners in Care Living Alone Plus) is a research project designed to assist people with early-stage memory loss who live alone in the community by providing early-stage related education and skill-training sessions, held via Zoom, designed to reduce stress, enhance well-being, manage challenges, and plan for the future. Researchers will gather feedback from individuals about their experience to continue to improve programs for early-stage memory loss.

The goal of this clinical trail is to test the developed eMPrISe study in HIV-negative, adult, Latino men who have sex with men (MSM) who use non-injection substances. The main questions it aims to answer are: * Can participation in the developed eMPrISe study reduce methamphetamine ('meth') use risk? * Can participation in the developed eMPrISe study improve preexposure prophylaxis (PrEP) cascade progression? Participants will participate in 12 weekly modules that: (1) build critical thinking skills, (2) identify and discuss the link between oppression and harmful behaviors, (3) take action, (4) voice and validate feelings and experiences, and (5) share knowledge and resources.