Palavas Les Flots

Researchers are examining the impact of adding short, intense "exercise-snack" sessions to a traditional multidimensional care program for obese adolescents. The aim is to see if these brief exercises can help improve physical fitness, body composition, vascular function, and reduce sedentary behavior among hospitalized obese children aged 11 to 18 years. This study compares the effects of the standard care program with and without these added exercise sessions over both short and medium timeframes. Participants will be divided into two groups: one receiving the standard care program alone, and the other receiving the same program plus four 1-minute intense supervised exercise sessions daily for three weeks. These "exercise-snacks" are designed to interrupt sedentary time and encourage physical activity. Both groups will receive education about physical activity attitudes as part of their care. Throughout the study, physical fitness, body composition, vascular health, and activity levels will be assessed at the start, end of the three-week program, and again at 1 and 3 months after the program ends. Researchers will monitor changes in aerobic fitness measured by predicted VO2max to evaluate the effects of the interventions. This study involves a total participation period extending three months beyond the exercise program to observe lasting impacts.

Congenital heart disease (CHD) is a common birth defect where over 90% of affected children survive into adulthood. However, half of these children may develop neurodevelopmental disorders (NDD) that can impact their learning, social integration, and quality of life. In France, there is a shortage of medical resources to screen for NDD in children with CHD and to provide early treatment. This research evaluates the use of an Advanced Practice Nurse (APN) to systematically screen children aged 1 to 5 years with CHD for NDD during their routine cardiac follow-up. The screening uses the Ages & Stages Questionnaires (ASQ-3) and the Haute Autorité de Santé (HAS) identification scale. Children suspected of having NDD will be referred to a neuropsychologist for confirmation and management. Those with higher risks, such as those who had neonatal cardiac surgery, will receive a systematic neuropsychologist evaluation. Participants will be monitored to assess the feasibility and accuracy of this screening approach. The main outcome measured is the sensitivity of the APN screening for detecting NDD after 4 months, confirmed by a neurophysiologist's assessment. This study aims to improve early identification and care for children with CHD at risk of neurodevelopmental issues.

Researchers are investigating a neuro-cardiac rehabilitation program aimed at improving physical and mental health in children, adolescents, and young adults aged 8 to 25 years with rare and complex congenital heart disease (CHD). Long-term complications in this group include neurodevelopmental challenges, mental health issues, and reduced exercise capacity, which negatively impact quality of life. This multicenter randomized controlled trial compares the new integrative neuro-cardiac rehabilitation program to the standard cardiology care to assess improvements in health-related quality of life and other outcomes. The intervention group will participate in a 12-week neuro-cardiac rehabilitation program that includes home-based adaptive physical exercise, telehealth psycho-education sessions for both parents and children, computerized cognitive training for children, and in-person reinforcement sessions. Parents will be actively involved and receive personalized feedback and educational resources. The control group will receive standard care consisting of routine cardiology consultations without additional physical or cognitive training during the study period. Participants will be assessed over 12 months, with measurements including the Pediatric Quality of Life Inventory (PedsQL) 4.0 questionnaire as the primary outcome, along with evaluations of cognitive skills, mental health, and cardiovascular and physical health parameters. The study includes regular monitoring through standardized assessments and patient-reported outcomes to evaluate the long-term effects of the intervention on quality of life and health status.

This research aims to evaluate how the Omnipod 5 Automated Insulin Delivery System affects blood sugar control, quality of life, satisfaction, patient experience, and rates of sudden diabetes complications in real-world conditions. The study focuses on individuals with type 1 diabetes, both adults and children aged 2 years and older, who have started using the Omnipod 5 System with a FreeStyle Libre 2 Plus sensor in France. Participants use the Omnipod 5 System, a tubeless insulin pump that delivers insulin automatically when paired with compatible continuous glucose monitors. This non-interventional study follows patients for 12 months after they begin using the device in automated mode to collect data on device use and glycemic control. During the 12 months, researchers will monitor participants' blood glucose levels, quality of life, device safety, and usage patterns. They will measure changes in the time blood sugar stays within a target range (70-180 mg/dL) from baseline to 12 months. Participants will complete questionnaires and stay in contact with study staff throughout the follow-up period to track outcomes and ensure safety.

Congenital heart disease (CHD) is a common birth defect affecting about 1% of live births, with many children now surviving due to advances in surgery. This research evaluates how prenatal maternal mental health affects the neurodevelopment of children born with complex CHD who need open-heart surgery shortly after birth. The study also explores factors influencing maternal mental health during pregnancy and the role of paternal or co-parent mental health on child development. The study follows mothers, fathers or co-parents, and their children from the third trimester of pregnancy until the child reaches 12 to 18 months old. Mothers will have detailed psychological evaluations three times: late pregnancy, before the baby leaves intensive care, and when the child is one year old. Fathers or co-parents will complete mental health questionnaires during pregnancy. The infants will undergo neurodevelopment and behavioral assessments at about one year old, including tests for cognition, language, motor skills, and socio-behavioral traits. Participants will attend multiple visits for interviews, questionnaires, and child evaluations conducted by specialists. Researchers will measure maternal mental health symptoms and infant development scores using standardized tools. The study monitors outcomes like mental health over time and infant neurodevelopment at one year. All assessments follow established French norms and include clinical interviews and self-reports, aiming to understand how prenatal mental health influences long-term child development in CHD.

Researchers are studying the effects of capsinoid dietary supplements on brown adipose tissue (BAT) activity in obese adolescents aged 11 to 18. Brown adipose tissue is a type of fat that helps regulate energy by producing heat rather than storing fat. The study investigates whether taking capsinoids, natural compounds found in spicy peppers, along with dietary management can increase BAT activity, potentially helping with obesity and metabolism. This randomized, controlled, double-blind study focuses on obese adolescents and explores how capsinoids and lifestyle changes might affect BAT. Participants are divided into two groups for a 4-week multidimensional care program. The experimental group receives active capsules containing 9 mg of dihydrocapsiate daily, taken three times a day, while the control group follows the same care program but without the active supplement. The study compares the effects of capsinoid supplementation against a placebo in combination with diet and exercise over the 4-week period. During the study, researchers will measure temperature differences between the supra-clavicular region and the sternal control region before and after cold exposure at the start and end of the 4-week program. These measurements help assess BAT activity. Participants will be monitored to evaluate how capsinoid supplementation impacts BAT and overall energy metabolism, with safety and adherence tracked throughout the study.

This research aims to evaluate the ongoing safety, performance, and patient quality of life related to the Control-IQ system in managing type 1 diabetes. It is a post-market surveillance study assessing the device in all approved populations over a 12-month period. The study focuses on the rate of severe metabolic complications like diabetic ketoacidosis (DKA) and severe hypoglycemia, as well as patient satisfaction and real-world use of the system. Participants will use the t:slim X2 insulin pump equipped with Control-IQ technology along with a Dexcom G6 or G7 continuous glucose monitor. After starting use of the system, participants will be followed for 12 months to monitor their glycemic control, device usage, and quality of life. The study collects data on device performance and patient experiences during this time. During the study, participants will be monitored for safety through the tracking of severe hypoglycemia and diabetic ketoacidosis events over 12 months. Researchers will also assess glycemic outcomes and gather patient-reported feedback on satisfaction, trust, usability, and quality of life improvements. Participants are expected to complete questionnaires and allow access to clinical data, including recent HbA1c results, to support these assessments.