Clinical Research Directory

Remote Exercise Program for Rural Men

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a remote physical activity intervention designed for rural inactive men.

The Food for Health Study

The project, called Food for Health (F4H), will study a new Produce Prescription Program (PPP) designed for rural Native American older adults. The study is based in the Confederated Salish and Kootenai Tribes (CSKT) of the Flathead Indian Reservation in Montana. In this community, many older adults face food insecurity and higher risk for Type 2 Diabetes (T2D). The tribal health department (THD) and local Food Resource Center (FRC) already provide important health and food support services, and this project builds on these strengths. Produce Prescription Programs (PPPs) is a type of nutrition support intervention that connects healthcare providers with local food programs to help patients access fresh, healthy foods. For example, an individual enrolled in the study will be "prescribe" fruits and vegetables in the form of a vouchers or coupons, which can be used to buy these foods at local food centers. Research shows that this type of program can reduce food insecurity, improve diet, and support better health. PPPs also fit well with tribal community priorities by supporting food sovereignty, culture-based nutrition education, and a stronger local food system. A key part of the study approach is using Community-Based Participatory Research (CBPR). CBPR means that community members, health providers, and researchers work together as equal partners. This way, the program is not just designed "for" the community, but "with" the community. The CSKT THD and community members have been involved in shaping this project from the start, and their priorities-like food security and food sovereignty-are at the center of the work. The investigators will carry out the study in two phases. Phase 1: Investigators will pilot test the acceptability of F4H in a small group of older adults (N=10) to understand the program's acceptability. The results will be used to refine and improve the program before moving to the next phase. Phase 2: Investigators will test the feasibility and impact of the refined F4H program with a larger group of older adults (N=33). Participant food insecurity and T2D risk factors, such as blood sugar and weight, will be measured before and after the program. Investigators expect that participants will have less food insecurity and healthier measures after completing the program. The clinic-to-community model is central to F4H. The THD will provide the prescriptions, and the FRC will be where participants redeem vouchers for fruits, vegetables, and other nutritious foods. The program will also include nutrition education that is grounded in Native culture and values. This model helps strengthen connections between healthcare and community services, creating a more supportive system for older adults. In addition to testing the program, investigators will study how it is carried out. This is called implementation research. It means paying attention to how the program fits into the community setting, what helps it succeed, and what barriers might need to be addressed. Understanding these factors is important so that the program can continue in the future and potentially be expanded to other Native communities. The long-term goal of F4H is to empower Native American communities to improve nutrition and reduce health disparities. By supporting older adults in gaining better access to healthy foods, the aim is to lower diabetes risk, improve quality of life, and strengthen local food systems. If the program is successful, it can serve as a model for other rural communities facing similar challenges.

Forge AHEAD: Feasibility of Yoga to Improve Cognitive Function

The investigators will conduct a two-phase pilot study to test the feasibility and acceptability of a 12-week Chair Yoga intervention for 20 heart-failure patients. Using a patient-centered approach, investigators will involve stakeholders in designing the protocol, gather patient feedback, and refine the protocol accordingly.

Virtual Reality Lethal Means Safety Training

The goal of this randomized clinical trial is to determine whether a virtual reality (VR) training program can help healthcare providers improve their skills in discussing suicide prevention and safe storage of firearms and medications with Veterans. The study will test whether VR training increases providers' self-efficacy, confidence, and comfort in conducting lethal means safety counseling, and whether it improves their intention to use these counseling practices in their clinical work. Researchers will compare healthcare providers who complete the VR training to those who complete a 2D video training to determine whether the VR approach is more effective. Participants will complete online surveys before and after the training and again three months later. They will be randomly assigned to one of two groups: VR training group: Participants use a VR headset to interact with a virtual Veteran patient in a simulated rural clinic and practice suicide prevention counseling skills; Video training group: Participants use the same headset to watch a \~10-minute 2D video depicting the lethal means safety counseling session. After the training, participants will also provide feedback about their experience, including how realistic and useful they found the training.

Nutritional Prehabilitation to Improve Cancer Outcomes (N-PICO)

Brief Summary The goal of this clinical trial is to evaluate the acceptability and adherence of low- and high-intensity remote nutritional interventions for cancer patients in rural and urban areas, specifically focusing on those with invasive cancer who are about to start treatment. The main question\[s\] it aims to answer are: Can low- and high-intensity remote nutritional interventions improve adherence to cancer treatment and quality of life? What is the impact of nutritional support on treatment delays, unplanned healthcare utilization, and dietary modifications? Researchers will compare the low-intensity arm (initial nutritional consultation plus written materials) to the high-intensity arm (1-hour consultation, monthly follow-ups, and written materials) to see if higher intensity interventions lead to better outcomes in terms of adherence, quality of life, and healthcare utilization. Participants will: Receive either a low- or high-intensity nutritional consultation. Complete surveys assessing quality of life, dietary habits, treatment delays, and unplanned healthcare use. Be asked to participate in monthly follow-up consultations (for the high-intensity group) to track progress and provide additional support.

Comparative Study of Simulation Technologies for Use in Neonatal Resuscitation Training for Rural Hospitals

Conduct a randomized cluster non-inferiority clinical trial with teams of interprofessional neonatal clinicians from rural delivery hospitals. In this trial we will compare HoloBaby, a novel mixed reality simulator technology, to traditional high-technology simulator technology.

iAmHealthy Clinical Practice Guideline (CPG)

The current study is a multilevel factorial design RCT with interventions at the clinic (Healthy Clinic intervention period vs. Control period) and individual patient levels (iAmHealthy vs. Newsletter).

Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START

The goal of this observational study is to learn about the roles played by parental activity spaces and social networks in reducing parental substance use and promoting child and family health outcomes in the context of Ohio START (Sobriety, Treatment, and Reducing Trauma) for families in rural areas. This study will investigate if substance use treatment service referrals and family peer mentoring services provided by Ohio START lead to positive changes in parental activity spaces and social networks, and if these positive changes lead to better child and family outcomes. The main questions it aims to answer are: * Does having behavioral health services (referred by Ohio START workers) close to where parents spend their time help with substance use recovery and child health? * Does peer mentor support through Ohio START help parents build stronger social connections and family resilience, and does this lead to better long-term family health? * Do these associations differ in rural areas compared to urban areas? Participants will: * Answer survey questions about their substance use, parenting, child health, and family well-being across three waves (Wave 1: when they enroll in the study, Wave 2: 6-month follow-up, and Wave 3: 12-month follow-up) * Share information about places they go regularly (such as work, stores, and healthcare visits) * Share information about people in their support network

Latino Teen Pregnancy Prevention K23

The study will utilize an exploratory study design, applying formative research methods to inform the development and pilot testing of an unintended teen pregnancy prevention intervention.

Fostering Agricultural Relationships and Meaning - Thriving on Kinship

This study aims to enroll 65 participants who will be assigned to one of two groups. Each group will receive an intervention consisting of six weekly sessions of 40-60 minutes each. Eligibility includes residing in an agricultural area and reporting loneliness or feeling alone or disconnected.

Healthy Children, Healthy Communities: Effectiveness of a Multilevel Rural Community Engagement Model for Improving Children's Dietary Intake in Family Child Care Homes

The purpose of this study is to find out whether a program called "Healthy Children, Healthy Communities" can help young children in rural areas eat healthier and improve their health. The study focuses on children ages 3 to 5 who attend family childcare homes in rural communities. The main goal is to see if the program can: Help children eat healthier foods, like more fruits and vegetables. Support childcare providers in using positive mealtime practices that encourage healthy eating. The study will involve about 120 licensed family childcare providers in rural areas who participate in the Child and Adult Care Food Program (CACFP), along with about 240 children they care for. Childcare providers will be randomly placed into one of two groups: EAT Family Style Group (Intervention Group): Complete 7 online training modules over 16 weeks about healthy mealtime practices. Join 7 individual coaching sessions on Zoom. Record short videos of their mealtimes to get personalized feedback from a coach. Work with a coach to set goals and make plans to improve mealtimes. Receive printed materials and conversation cards to use during meals. Some providers may join Zoom interviews to share their experiences. Better Kid Care Group (Comparison Group): Complete 10 online modules about general childcare topics like child development, oral health, play, and managing a childcare home. For both groups, the research team will: Ask providers to fill out online surveys about how mealtimes work in their childcare homes. Visit the childcare homes to observe and record children's mealtimes on two days at each data collection point. Measure the height and weight of participating children. Use a painless skin scanner (Veggie Meter) to check how many fruits and vegetables children have been eating. Ask providers to complete surveys about the children's eating habits. The study focuses on rural, low-income communities, where children are at higher risk of having poor diets and obesity compared to children in urban areas. Information will be collected at the start of the study, after 16 weeks, and again after 24 weeks to see if there are lasting changes.

Rural Autistic Individuals - Supporting Expression

This research study investigates how hand gestures can support language comprehension and communication skills of hearing speaking, non-speaking, and/or minimally verbal individuals with Autism Spectrum Disorders (ASD), who are especially disadvantaged by the lack of accessible services in their rural communities. Individuals with other cognitive profiles, including Developmental Language Disorder (DLD), ADHD, Dyslexia, and others are welcome too. The study uses methods of eye tracking and recording of brain activity to understand how hand gestures adapted from signs from American Sign Language, such as \[cry\], can promote successful understanding of words like "cry". The overarching goal is to help families effectively utilize gestures to support communication with their children.

SUPERSTARS: Supermarket Support for a Primary Care Healthy Food Prescription

Few Americans meet dietary recommendations. Poor diet is a major contributor to increasing prevalence of diabetes and obesity, which are negatively impacting long term health, quality of life, and healthcare costs, particularly among low-income, racial and ethnic minority, and rural populations in the U.S. To help address these inequities, produce prescription programs are being implemented in many health care settings. However, key research gaps and programmatic barriers remain. In the proposed project, the investigators will use research, education, and extension to improve nutrition security in rural underserved communities and deliver science-based knowledge to consumers, allowing them to make informed, practical decisions that can improve health equity. The project goal is to implement and rigorously evaluate an innovative primary-care based healthy food prescription that is paired with incentives to use the local supermarket's established healthy food shelf-tag labeling system to increase healthy food choices at the point of purchase. The investigators will: 1) assess the program's impact on participants' food and nutrition security, 2) assess the program's impact on participants' supermarket purchases and diet, and explore the program's impact on health, and 3) use the research findings to engage health systems, nutrition educators, and communities in evidence-based strategies to improve nutrition security. The program has the potential to sustainably encourage healthy food choices where decisions matter-in the supermarket, using existing supermarket resources. Improving purchasing patterns by increasing sales of less processed and whole foods, could also positively affect industry offerings and sustainability of the agricultural system as a whole.

Risk Underlying Rural Areas Longitudinal Cohort Study (RURAL) Heart and Lung Study

The University of Texas Health Science Center at San Antonio (UTHSCSA) will serve as the site for the RURAL Study Coordinating Center, led by PI Vasan Ramachandran, MD. The primary function of the Study Coordinating Center (SCC) is to serve as an administrative liaison between all of the RURAL study's cores. The SCC schedules, facilitates, and hosts, all RURAL meetings including preparation for Observational Study Monitoring Board (OSMB) meetings, and maintains direct communication with the study's program officers at NHLBI. The SCC monitors the overall progress of RURAL and keeps all RURAL cores abreast of study updates through meetings, emails, newsletters. It also maintains the official RURAL website and serves as an administrator for investigators seeking to collaborate with RURAL through the submission of Ancillary Studies. The SCC will have no direct interaction with any participants, nor will it have access to identifiable data.