Clinical Research Directory

Bedtime Stories: Tailored Sleep Health Messaging for Caregivers

To date, there are very few established sleep health education models targeting caregivers of school-aged children from historically marginalized and/or low income communities. To address this significant gap, this project seeks to examine the feasibility, acceptability, and usability of the Bedtime Stories Sleep Health Education Program to improve sleep behavior. Bedtime Stories is a multi-stakeholder (health care providers, school-aged children, and caregivers of school-aged children) and a multi-component program. The caregiver component of the program utilizes mobile health technology with targeted and tailored sleep health messaging for caregivers of school-aged children. Addressing these aims will help to mitigate gaps in the delivery of health care services to caregivers and families in low income and historically marginalized communities, where services and interventions are scant.

Cognitive Remediation Intervention to Prepare for Transition of Care

Randomized Controlled Trial (RTC) testing the efficacy of a telehealth adaptation of the Cognitive-Remediation of Executive and Adaptive Deficits in Youth (C-READY) intervention to prepare adolescents with sickle cell disease for transition of care.

Preventive Remediation for OptiMal StudentS (PROMESS-Group)

Health students exhibit excessive sedentary behavior, elevated stress levels, and significant sleep disturbances, all of which contribute to a decline in their overall health, quality of life, and learning capacities. The PROMESS-Group project (Preventive Remediation for OptiMal StudentS-Group) is a multimodal intervention targeting stress management, sleep improvement, and physical activity enhancement, with the aim of improving students' quality of life throughout their academic journey. Encouraging physical activity, reducing sedentary behaviors, reducing stress, fatigue and sleep troubles during their curriculum can promote a healthier lifestyle and reduce the risk of chronic health conditions in the future. The study seeks to quantify the impact of a complex intervention based on 3 modules (stress, sleep, physical activity) on the quality of life of health students. This study will also have a clear insight on the influence of the complex intervention on changes in stress, sleep, physical activity and sedentary behavior markers.

Yoga With and Without VR for Core, Balance, and Stress in University Students

The present study aims to investigate the combined and comparative effects of yoga exercise performed with and without virtual reality (VR) support on stress levels, core stabilization, and balance in university students aged 18-30. Participants will be screened using validated stress assessment tools to ensure inclusion of individuals with moderate to high perceived stress. Eligible participants will then be randomly assigned to one of two groups:(1) a virtual reality yoga group (VRYG), in which yoga sessions are delivered through immersive VR environments with therapist-guided breathing and movement instruction; and (2) a Traditional Yoga Group (TYG), in which the same therapist will give the same breathing and movement instructions without VR. Both groups will undergo 12 supervised sessions over a period of four weeks (three sessions per week, each lasting 30 minutes). The intervention protocol includes a structured series of yoga postures designed to target trunk stability, flexibility, and balance, along with breathing techniques such as diaphragmatic breathing and the 4-7-8 method to promote relaxation and stress reduction. The VR group will perform these exercise within calming, immersive virtual environments,while the control group will perform them in a quite,well-lit physical space. Outcome measures will be collected at baseline and after completion of the intervention. Psychological stress will be evaluated using the Depression, anxiety, and stress scale (DASS-21) with a focus on the stress sub-scale.Physiological indicators, including heart rate and blood pressure will be recorded at rest. Core stabilization will be assessed through plank and side-plank endurance tests, while balance will be evaluated using both static (single-leg stance) and dynamic (Y-Balance Test) protocols. These measures will allow for a comprehensive analysis of the intervention's effects on both mental and physical domains of health.

The Impact of Eating Habits on the Health of Employees in the Defense Sector

The PRENAV project focuses on healthy and sustainable eating among employees in the defense sector of the Republic of Slovenia. The project pursues two main objectives: 1. In a selected sample of employees in the defense sector, the project will determine their nutritional status and assess indicators of metabolic health, including serum concentration of vitamin D. 2. In the selected sample, through a survey and qualitative methods (interviews, focus groups), we will identify the eating habits of employees in the defense sector, the factors influencing their dietary decisions, and the barriers and facilitators of healthy and sustainable eating among employees in the defense sector. Based on these findings, we will prepare recommendations and an action plan to promote healthier and more sustainable eating among employees in the defense sector.

Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors

A retrospective crosssectional observational study of the effects of oncological treatment and frequent general anesthesia on neuropsychological development, psychosocial functioning (in terms of anxiety, depression, peer relations, perceived cognitive functioning and potential trauma) and health related quality of life in children and young adults who were treated or screened for retinoblastoma.

Exploring Neurophysiological Markers of Brain Health

The combination of transcranial magnetic stimulation (TMS) and electroencephalography (EEG) has been suggested as a promising brain imaging tool for identifying biomarkers of brain health. In this pilot study, study investigators will explore the neurophysiological metrics of brain health with a non-invasive brain imaging technique, alongside behavioral and fMRI metrics collected through another study (NCT04869111).

How Urban Interventions in Lower Socioeconomic Areas Influence Health Behaviors (UrbASanté Study)

The UrbASanté study is a quasi-experimental research that aimed at assessing the impact of urban transformations (a natural experiment) in the health related behaviors, environmental exposure and perceived- health.

Creating a New Health Promotion Module to Help the Indigenous People of Selangor Prepare for Disease X and Outbreaks

The goal of this cluster randomized trial is to develop and test a new method for preparing indigenous (locally termed as Orang Asli) households in Selangor, a state in Malaysia, for outbreaks and Disease X, a potential unknown infectious threat. It aims to determine if the new method, a health education package comprised of workshops, simulation exercises, and card game play sessions, can enhance the readiness of these families for such outbreaks. The main questions it is looking to answer are: 1. Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor? 2. Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness? 3. Will it lead to more proactive preparedness actions by these households? To evaluate the effectiveness of the intervention package, researchers will compare outcomes between two groups: the intervention group receiving both the intervention package and educational brochures on communicable disease prevention, and the control group receiving only the brochures. Participants will: 1. Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions. 2. Answer surveys four times: before, immediately after, 1 month after and 2 months after the intervention, to measure any changes in their preparedness levels for an outbreak.

Water is K'é: Multi-level Intervention to Promote Healthy Beverage Choices Among Navajo Families

The goal of this clinical trial is to understand if a cultural intervention for Navajo families will improve healthy beverage habits, health outcomes, and family cohesion. The main questions it aims to answer are: * Does Water is K'é results in healthier beverage habits among children aged 2 to 5, compared with children in a control group? * Does the intervention improve the health of other family members? * How does the intervention affect family well-being? Participants will take part in a four-month program at the early child education site (such as a Head Start or the Bureau of Indian Affair's Family and Child Education or FACE Program) where the child is enrolled. They will take part in lesson plans, a social media campaign, and a family water access plan. Researchers will compare the participating families with families at wait-list early child educations sites. We will collect information through surveys, health measurements, and qualitative interviews and compare results to learn if Water is K'e improves health behaviors, health outcomes, and family cohesion.

Public Survey on Breath Testing for Health and Disease

A brief survey for the public to determine interest in health surveillance and disease detection

Alteration of Sweet Taste Perception After Reduction of Sweet Food and Beverage Consumption.

The goal of this clinical trial is to determine whether reducing sugar intake by 50% for 12 weeks can change sweet taste perception in healthy adults and its consequences. The main questions it aims to answer are: * Does sweet intensity change after reducing daily sugar intake by 50% for 12 weeks? * How does sweet intensity change after completing dietary modification for 8 weeks? * Does individual daily sugar intake change after completing dietary modification for 8 weeks? Researchers will compare reducing daily sugar intake by 50% for 12 weeks to an unmodified diet to see if sugar reduction can change sweet intensity. Participants will: * Reduce daily sugar intake by 50% or maintain an unmodified diet for 12 weeks. * Visit the clinic three times for anthropometric measurements, sweet perception tests, and to complete questionnaires. * Keep a diet record for a total of 15 days during the research period.

Peer Support Program in Chronic Kidney Patient

The main advantage of patient-to-patient peer counseling is that it benefits both the client and the peer mentors as real and authentic experiences are shared. Since both individuals go through similar experiences, they can share common feelings. Although there are studies in the literature showing the effectiveness of peer support groups in different patient groups, studies on chronic kidney disease patients are limited. There are no studies on the effects of these programs on caregivers. This study will be conducted to examine the effects of peer support program applied to chronic kidney patients on patient outcomes and caregivers.

PODER Familiar: Health Promotion for Latino Families of Children With IDD

The goal of this clinical trial is to test a culturally tailored health promotion intervention for children with IDD and their families. First investigators will conduct a single group design pilot study of a health promotion intervention, followed by second, a small-scale randomized control trial (RCT). of the intervention with Latino parents of children with intellectual and developmental disabilities (IDD) in the Chicago, Illinois and Austin, Texas areas. The following research questions will be addressed: Question 1: What is the appropriate content, dosage, and delivery method of the intervention? Question 2: What is the feasibility and acceptability of the intervention? Question 3: Do participants improve between pre and post-test on outcome measures both in the one group design and compared to the control group in the RCT? Parents will receive 10 weekly remote sessions on health promotion content delivered by parent mentors called promotoras. Parents and children will attend 3 multi-family group workshops in-person that will provide demonstrations and interactive activities.

Health Literacy, Physical and Cognitive Function, Health-related Behaviors, and Quality of Life in COPD

Health literacy is important for controlling disease progression and living a healthy life with illness. High health literacy is associated with higher cognitive performance and lower health-related quality of life. Physical, psychological, and social impairments are seen in chronic obstructive pulmonary disease (COPD). Studies investigating the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD are limited. Therefore, the aim of this study was to compare individuals with COPD with healthy individuals in terms of health literacy, functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living and to investigate the relationship between health literacy and functional capacity, quality of life, physical activity, cognitive function, health-related behavior, and activities of daily living in individuals with COPD.

Effects of a Health Intervention on Fear of Hypoglycemia

To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.

A Group Intervention for Promoting Health-related Habits (LEV-G)

Health-related habits influences mental and physical health. Still, treatment of health-related habits, which can help to remedy health problems, is often not done at all or very superficially. Multiple guidelines emphasize the importance of prioritizing health-related habits, but there is a lack of implemented models. To solve this, the investigators have developed a transdiagnostic, interprofessional material intended for several care settings. The Lev-g intervention is intended for groups. There is also an individual version of Lev that has its on registration in Clinical Trails.

Exercise Effects on Health Status in Patients With Severe Mental Illness

People with severe mental disorders have a mortality rate 2 to 3 times higher than that of the general population, largely due to the presence of comorbidities, with a predominance of cardiovascular disease. This population has a higher risk of developing metabolic syndrome compared to the healthy population. Several factors are involved. The usual pharmacological treatment in people with severe mental disorder is a risk factor for the development of metabolic syndrome and deterioration of physical condition. This is generally compounded by poor health care, high-calorie diets, a sedentary lifestyle, difficulties in coping with life situations that generate emotional states (anxiety and/or depression) that result in unhealthy lifestyle habits related to food, activity, interpersonal relationships, sleep, consumption habits (tobacco, alcohol and drugs) and other environmental factors. Physical exercise has been proposed as one of the most effective treatments to reverse the negative consequences of low levels of physical activity in this population. However, the mechanism of action of exercise on health status and the optimal "dose" and intensity of exercise to achieve the greatest number of benefits with respect to cardiometabolic health in patients with severe mental disorder are unknown.The study will be carried out at the Mental Health Rehabilitation Unit of Navarra, a center under the Mental Health Management of Osasunbidea, where people between 18 and 65 years of age with a diagnosis of severe mental illness in a situation of clinical stability receive treatment.The sample will be composed of 100 participants from consecutive admissions to the Rehabilitation Unit. The subjects will be randomized into 2 groups; a control group that will receive the usual specialized care and an intervention group, which in addition to receiving the usual rehabilitation treatment, will undergo a 6-week multicomponent physical exercise program performed 2 days per week. The effects of exercise on the inflammatory profile, metabolic parameters, physical condition, cognitive function, vascular function, muscle strength, health-related quality of life, lifestyle habits (diet, activation, sleep, substance use) and mood will be evaluated.