Palavas Les Flots

Researchers are investigating whether adding very short, intense exercise sessions called exercise-snacks to a traditional care program can improve physical fitness and health in obese adolescents. This study focuses on adolescents with obesity and sedentary lifestyles, aiming to reduce sedentary behavior and improve body composition, vascular function, and physical activity habits. Forty-eight obese adolescents will participate in this randomized study to evaluate the benefits of these exercise-snacks alongside standard care. Participants will be randomly assigned to one of two groups. The exercise-snack group will perform four brief, intense exercise sessions each day for three weeks in addition to receiving a multidimensional care program. These sessions last about one minute each and are supervised. The control group will receive only the standard care program without exercise-snacks. Both groups will receive education about physical activity attitudes. During the study, researchers will assess physical fitness, body composition, vascular health, eating behaviors, and levels of physical activity and sedentary behavior. Evaluations will take place at the start and end of the three-week program, and again at one and three months after the program ends. The main measure is change in aerobic fitness, with other outcomes including changes in fat mass, body mass index, carotid artery thickness and compliance, and questionnaires about physical activity and eating habits.

Researchers are evaluating the feasibility and effectiveness of screening for neurodevelopmental disorders NDD in children aged 1 to 5 years with congenital heart disease CHD, a group at high risk for these conditions. This study aims to address a gap in early detection and referral for appropriate care, as over half of children with CHD may develop NDD that can impact their education, social integration, and quality of life. The research is sponsored by the University Hospital in Montpellier and focuses on improving early diagnosis and management in this vulnerable population. The study involves screening children with CHD during their routine cardiac follow-up visits using a screening performed by an Advanced Practice Nurse APN. The screening uses tools such as the Ages & Stages Questionnaires ASQ-3 and the Haute Autorit de Sant HAS identification scale. Children who show signs of possible NDD will be referred to a neuropsychologist for a detailed evaluation and care planning. Those at higher risk due to early cardiac surgery also receive systematic neuropsychological assessments. Participants will be monitored over several months, with the main outcome being the sensitivity of the APN screening to detect NDD confirmed by neuropsychologist assessments within four months. Additional outcomes include feasibility, performance measures like specificity and predictive values, and prevalence of NDD in high-risk children over an 18-month period. The study involves collecting screening results, neuropsychological evaluations, and following childrens neurodevelopment, aiming to improve early identification and intervention strategies.

Researchers are evaluating a home-based neuro-cardiac rehabilitation program for children, teens, and young adults aged 8 to 25 years with rare and complex congenital heart disease CHD. The study aims to address common long-term challenges in this population, including neurodevelopmental difficulties, mental health issues, and reduced exercise capacity, which negatively impact quality of life. This randomized controlled trial compares the new integrative program combining physical and psychological rehabilitation to the standard cardiology care. The intervention group will participate in a 12-week program that includes two weekly sessions of adapted physical exerciseone in person at home and one via videoconferencefocusing on bicycle training and other activities. Additionally, they will engage in computerized cognitive training sessions and telehealth psycho-education for emotional regulation and executive functioning, involving both patients and their parents. The control group will receive standard cardiology care without additional rehabilitation activities. Participants will be assessed over 12 months for changes in health-related quality of life, cognitive and mental health outcomes, and physical and cardiovascular measures. Assessments include standardized questionnaires, neuropsychological tests, and cardiopulmonary exercise tests. Parents will be actively involved and receive personalized feedback and educational resources. The study will measure the effectiveness of this comprehensive program to potentially improve care for children with rare CHD.

Researchers are evaluating the Omnipod 5 Automated Insulin Delivery System in people with type 1 diabetes aged 2 years and older. This study aims to observe real-world use of the device over 12 months, focusing on blood sugar control, quality of life, patient satisfaction, and rates of acute diabetes complications. The study is non-interventional and prospective, involving multiple centers in France. Participants use the Omnipod 5 System, a tubeless automated insulin pump designed to deliver insulin under the skin and used with compatible continuous glucose monitors such as the FreeStyle Libre 2 Plus sensor. The study follows patients for 12 months after they start using the system in automated mode. During this time, researchers collect data on how well blood sugar levels are controlled and how participants use the device. Throughout the study, participants complete quality-of-life questionnaires and treatment satisfaction surveys at the start, 6 months, and 12 months. Data on glucose levels, insulin delivery, and diabetes complications are collected continuously during the 12-month period. Safety, device usage patterns, and reasons for stopping the system are also monitored. Participants remain under their usual medical care while contributing data to this observational study.

Researchers are investigating how prenatal maternal mental health affects the neurodevelopment of children born with congenital heart disease CHD requiring neonatal open-heart surgery. The study focuses on children diagnosed in the womb with complex cyanotic heart defects that may lead to rapid oxygen shortages after birth. It aims to understand the relationship between prenatal maternal psychological distress and child development at age one, including the role of sociodemographic and medical factors, as well as paternal or co-parent mental health. This observational study follows participants from the third trimester of pregnancy until the child reaches 12 to 18 months old. Expectant mothers undergo three psychological assessments the first after 28 weeks of pregnancy, the second after the babys surgery during hospitalization, and the third when the child is one year old. Fathers or co-parents complete self-reports during the prenatal period. Infant neurodevelopmental and behavioral evaluations occur at the one-year visit, assessing cognition, language, motor skills, and social behavior. Participants will attend multiple visits for psychological and developmental assessments conducted by licensed professionals, including standardized self-report questionnaires and clinical interviews for mothers. Child evaluations are performed by pediatric neuropsychologists using validated tools with French norms. Researchers measure maternal mental health symptoms and the childs development using established scales. The study tracks outcomes such as maternal distress and infant cognitive and motor abilities, with follow-up continuing through the first year of life.

Researchers are investigating the effects of capsinoid dietary supplements on brown adipose tissue BAT activity in obese adolescents aged 11 to 18 years. BAT is a special type of fat that helps regulate energy use by producing heat, which may help reduce obesity. This study aims to see if capsinoid supplements combined with dietary management can increase BAT activity in this group. Participants will be randomly assigned to one of two groups. One group will receive capsules containing capsinoids, a compound found in sweet peppers and chillies, taken three times daily for four weeks. The control group will receive similar capsules without the active ingredient. Both groups will participate in a four-week multidimensional care program during the study. Throughout the study, researchers will measure changes in BAT activity using temperature differences in specific body regions before and after cold exposure. Other assessments include blood flow, metabolism, heart rate patterns, blood sugar and lipid profiles, hormone levels, body measurements, eating behavior, and pubertal development. Treatment adherence will be monitored continuously during the program, with evaluations at the start and end of the four weeks.

This research aims to evaluate the ongoing safety, performance, and quality of life associated with using the Control-IQ system in people with type 1 diabetes. The study is a post-market surveillance, single-arm, prospective cohort design conducted in France and sponsored by Tandem Diabetes Care, Inc. It focuses on the first 12 months of real-world use of the Control-IQ system across all approved populations. Participants will use the tslim X2 insulin pump with Control-IQ technology combined with Dexcom G6 or G7 continuous glucose monitoring sensors. They will follow standard care practices while using the system continuously for 12 months. The study observes the devices safety by measuring rates of severe metabolic complications like diabetic ketoacidosis and severe hypoglycemia during this period. During the study, participants will provide data on their blood glucose levels and device use, while also completing questionnaires about their treatment satisfaction, system usability, quality of life, and fear of hypoglycemic events. Researchers will monitor glycemic control outcomes such as time in target glucose range and time spent above or below specified glucose levels. The study follows participants for one year, including tracking device usage and collecting clinical data according to usual care standards.