Tirzepatide is an investigational medication that has been studied for the treatment of diabetes when administered once a week by self-injection. In these trials people who received the medication also lost some weight. This study is being done to see how safe tirzepatide is and how well it will work to help people who are obese or overweight to lose weight, when it is used along with a reduced-calorie diet and increased physical activity.
Participants will be randomly assigned to one of three doses of tirzepatide or to a placebo (inactive look-alike drug). They will be followed for either 72 or 176 weeks depending on the results of an initial test of blood sugar control.
This feasibility trial is a multisite, randomized control trial of two different methods of identifying and recruiting participants into the I Am Healthy behavioral intervention. Children and caregivers in both arms will receive the usual care for all existing medical conditions throughout the trial period. they will also receive a monthly newsletter for six months. In addition to the newsletter, child/primary caregiver pairs in the I Am Healthy behavioral intervention arm will receive both group and individual counseling sessions. The trial intervention period will last for six months and will consist of 15 hours of group sessions and 11 hours of individual sessions for 26 contact hours. This falls within the 26-51 contact hour category, which is significantly more effective than the 6-25 contact hour category per the recent USPSTG guidelines. This feasibility trial will provide information toward the implementation of a fully powered multi-site randomized behavior intervention trial that will compare the effectiveness of the I Am Healthy behavioral intervention to a newsletter-only intervention for the treatment of obesity among rural and under served children and their primary caregivers.
Youth with one or more chronic diseases are at increased risk of further complications, disease, or even early death as they enter their adult years. Recent increases in both asthma and obesity among youth have led to high health care utilization, increased health-related complications, and expanded risks of subsequent cardiovascular disease burden. The research team will develop educational content in core areas (e.g., fatigue, physical activity) for Managing AsThma AnD Obesity Related Symptoms (MATADORS), an mHealth technology-enhanced nurse-guided intervention. Youth with asthma and obesity and their primary caregivers will participate in interviews to explore their perspectives on barriers, facilitators, needs, and preferences toward adopting health behaviors, medication adherence, disease awareness, symptom self-management behaviors, and utilization of a mobile smartphone platform. Additional details on content availability, delivery approaches, system needs, and functionality will be explored through semi-structured interview questions. Health care providers (physicians, nurses, nurse practitioners, dietitians, and respiratory and exercise therapists) will be invited to participate in interviews to seek their input on patient-caregiver needs, priority clinical focal areas, recommendations for symptom self-management, and preferences for intervention delivery. Interview findings will be used to inform intervention and app design. Providing youth with strategies to enhance symptom self-management may result in decreased symptom prevalence, improved quality of life, and long-term reduction of cardiovascular morbidity and mortality as they move into adulthood.
Non-Alcoholic fatty liver disease is the most common liver disease, and involves fat deposition in the liver. The fat in the liver can lead to inflammation, scarring, end stage liver disease and potential liver cancer. Some patients with fat in their liver do not see these changes, and our current understanding of why some people are not affected while others see progression of their disease is poor. We are currently in process of initiating studies to learn more about fatty liver disease, and having a database of patients at the VA medical center who are willing to participate in these studies and future studies would help both the patients learn about the new and upcoming therapies, and help the clinical investigators to quickly screen their patients and invite them to participate in their studies.
The TRANSFORM network is focused on improving child health outcomes in SC through research on conditions of highest priority for future generations. These include conditions like asthma, autism, diabetes, obesity and early childhood outcomes. To accelerate research study recruitment activities for future projects that TRANSFORM sites may participate in, the TRANSFORM network sites will create a research recruitment registry of families interested in volunteering for research. Participants will enter their own as well as their child(ren)'s information into the electronic registry which can be used to identify people to contact for future studies.
This trial of pitavastatin will determine efficacy and safety in this high risk population, and provide evidence for clinicians to target this treatable risk factor to achieve an impact on early atherosclerosis, and potentially achieve primary prevention of adult cardiovascular disease.
TARGET-HCC is a 5-year, longitudinal, observational study of the natural history and management of patients with HCC. The study will address important clinical questions that remain unanswered in the management of HCC with a unique research registry of participants with HCC from academic and community real-world practices. TARGET-HCC is disease focused, not drug specific, which allows for continuous acquisition of real-world evidence regarding the natural history, management, and outcomes of treatment with current therapies and new treatments that may be utilized in usual clinical practice.
This is a 5-year, longitudinal, observational study of patients with NAFL or NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, a bio specimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.