Health Behavior Clinical Trials

The program consists of four interconnected components: (1) app, (2) accelerometer, (3) health coaching, and (4) behavioral incentives to increase food and vegetable intake, reduce saturated fat intake, increase physical activity, and decrease sedentary screen time among adults Appalachia Kentuckians. Read Less

Center for BrainHealth is beginning a one-year pilot with local college campuses investigating the impact of (i) brain health assessment and training tools delivered through the online BrainHealth Platform and (ii) in-person educational brain health workshops delivered to college students and faculty/staff, with the overarching goal to better understand how to promote brain-healthier campuses (i.e., reflecting generally positive function across cognitive, social, emotional, and lifestyle domains). This initial study is intended to be a one-year pilot, with findings informing feasibility and efficacy as well as future, more extended and expanded study informing translation to other colleges/universities. Read Less

The treatment of generalized anxiety disorder (GAD) in an accessible manner represents an unmet need for those with cardiovascular disease (CVD), given that patients with CVD experience numerous barriers for in-person treatment engagement. The research plan for the proposed pilot project will entail: (1) open study of the acceptability of the digital intervention (N=5), followed by (2) recruitment and randomization of 90 individuals with a history of acute CVD events and clinical levels of GAD symptoms to dCBT or a waitlist (Control) condition, using a 1.5:1 allocation (dCBT:Control). Read Less

The Lake Nona Life Project aims to examine the health and wellness of participants over the course of multiple years, focusing on the links between health and wellness, longevity, quality of life, and human performance. Read Less

We will conduct a two-group randomized controlled trial to examine the eMocha DOT intervention with pediatric HT recipients.In this population, medication nonadherence remains a primary cause of late acute rejection (LAR) episodes, increased number of hospitalizations, graft failure, and patient mortality. Herein, we propose an innovative approach to promote medication adherence and improve patient and graft outcomes. Read Less

The primary objective of the proposed study is to complete a comprehensive needs assessment of the Louisiana National Guard (LANG) Youth Challenge Program (YCP) in the YCP leadership and junior cadet population related to nutrition, fitness, sleep, and mental health and resilience. Results of this needs assessment will further inform the development of the intervention skills training program. The secondary objective of this work is to provide a scalable, integrated physical and mental optimization training program that would be integrated into relevant systems and maintained over time as a core tool for young individuals readying themselves to join the Army. The program would include an environmental intervention approach as well as nutrition, physical activity, sleep, and stress reduction/positive coping guidance. Read Less

The purpose of this study is to investigate the safe wearability and basic functions of the multi-modality sensors fabricated in the PI lab. Read Less

The study aims to implement Using the Connect (UTC), an innovative, game-based intervention designed to increase protective factors and decrease adolescent pregnancies. This intervention will be implemented in Texas middle schools and community-based organizations. The long-term goal is to promote optimal health in youth and prevent adolescent pregnancy in populations disproportionately impacted by adolescent pregnancy and sexually transmitted infection (STI) rates. The short-term objective is to conduct a robust, multi-site clustered randomized controlled trial to evaluate implementation outcomes and the impact of UTC, a novel theory-based game developed using powerful and effective human-centered design (HCD) strategies, on intention to delay sexual activity. Read Less

The study will test the effectiveness and examine the sustained effects of weekly programming on enhancing (1) lifestyle behaviors (physical activity, dietary intake, use of technology, amount of sleep), (2) self-efficacy, (3) self-esteem, and (4) readiness to change among children ages 8-11 years. Read Less

The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children. Read Less

This study is testing the efficacy of the integrative approach to: teach 5th grade children menu board calorie literacy as measured by our novel recently validated menu board calorie literacy (MBCL) instrument; provide strategies designed to improve food purchasing behaviors; and facilitate the transmission of core lesson messages from children to parents via a procedure that we have termed "Child Mediated Health Communication (CMHC)". Read Less

Feasibility Study Informed consent will be obtained using an IRB-approved form. The first 12 consenting patients will be placed in the planned assessment group for feasibility and will not be randomized. These participants will undergo visits and blood draw collection at 3 months. They will be informed of their SomaSignal Test results at baseline and 3 months. Recommendations for any medical management changes will be made based on an understanding of those results. Randomized Study The succeeding 200 participants will be randomized using permuted mixed block randomization, in a 2:1 ratio, i.e., 2 participants to Group 1 (informed of their test results) and 1 participant to Group 2 (uninformed of their test results). At enrollment, and for 6 months thereafter, clinical information will be obtained from each participant's medical records, and/or directly from the participant during procedures, treatments, study-specific visits, and/or follow-up visits. Data collected for the study will have data linkage at SomaLogic, Inc., where data analysis will be done. At baseline and 6-months (+30 days) post-enrollment, patients will undergo a patient visit and blood collection. Blood will be collected as a stand-alone sample collection, or when other ordered lab work is done, or from access lines inserted during a usual or specialized care. Samples will be sent to the Intermountain Central laboratory for clinical testing. A sample will also be processed and shipped to SomaLogic, Inc. for analysis at baseline and 6 months. For the informed arm, the SomaSignal Test reports will be provided at the time they are available (2 to 4 weeks after the blood draw). Any recommended changes in medical management will be recorded in the case report forms and will be verified by the Principal Investigator. For the uninformed arm, the SomaSignal Test results will not be provided to the study team until after the 6-month post-test visit. Adjustments, if any, would be made to the participant's management at that time. Read Less