View clinical trials related to Pediatric Obesity.
Filter by:Overweigth and obesity are commonly diagnosed in children with type 1 diabetes, and frequently an increase of wiegth and BMI is observed after diagnoses. Hybrid cloosed loop system are new system where insulin is continually adapted to glycemia (using an algorythme). The weight and growth trajectory of children treated with this system is poorly described.
The FACILITY STUDY is aimed at evaluating maternal and children social, cultural, economic and lifestyle-related risk factors for the development of childhood overweight, obesity and early adiposity rebound (EAR). This study consists of two phases: a cross-sectional phase and a retrospective case-control study.
Lead: UNIVR, Partners involved: UNIME, CHU Lille, INSERM-Lille This is a multi-center (UNIVR, UNIME, CHU Lille) randomized controlled trial aiming at evaluating the effect of a selective intervention directed to parents of newborns. 1500 subjects will be recruited in both arms and evaluated with the "Childhood Obesity Risk Score" (COBRISC), thanks to anamnestic/clinical evaluations and molecular profiling (polygenic risk score) made at the child's birth. Participants of the intervention arm at the top tertile (33%) of the COBRISC, will access an intensive follow-up program (four visits/year on average, with anthropometric monitoring) at the local Obesity Tertiary Center. This will include educating parents on the appropriate diet, active lifestyle from the first year of life, regular self-monitoring of their child's anthropometry, appropriate dietary composition and portion control, as well as tailor-made nutritional suggestions. To ensure a patient-centred approach, the parents participating in the intensive follow-up program will annually give their feedback and suggestions by an anonymous online survey, whose results will be used to adapt interventions according to parents' requests, as possible and appropriate. The children of the intervention arm classified as not-at-risk will benefit from a "soft" intervention, consisting in the access to an educational website specially implemented with interactive tools for growth self-monitoring and diverse lifestyle suggestions. The children of the whole comparator arm will benefit from routine well visits from their general practitioner/paediatrician. This is based on the following rationale that: (i) targeted approaches imply higher motivation and commitment for parents, more intense care for families and more effectiveness and cost-effectiveness, compared to traditional population-based interventions; and (ii) early preventive trials have not demonstrated durable effects after the end of the intervention (no cascade effect), while uninterrupted intervention and follow-up from infancy to late childhood have proved long lasting results. The following end-points will be evaluated: Primary: overall percentage of children growing on an obesity trajectory at three years of age in the intervention compared to the comparator arm. Secondary: percentage of children growing on an obesity trajectory at three years of age in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm; physical activity and sedentary behavior at 1.5 years of age (EY-PAQ questionnaire), responsive feeding (Infant Feeding Styles Questionnaire (IFSQ) at 1.5 years of age, and dietary composition at three years of age (dietary diary and food frequency questionnaire) in the at-risk group of the intervention arm compared to the at-risk group of the comparator arm. All the children will be measured at the tertiary centre, at one, two and three years of age, and afterwards at six and ten years of age. All the intervention components will comply with the ESPGHAN Guidelines about infant feeding and complementary feeding, the Italian Consensus on Prevention and Treatment of Childhood Obesity, the Italian Reference Levels of Assumption of Nutrients and Energy, and the French Ministerial Recommendations about Nutrition and Physical Activity for infants and children. Who does what: UNIVR will be in charge of the study protocol writing. UNIVR will also provide Italian and French centers with educational and monitoring materials, including the web-based tool for parents. UNIVR will provide monitoring to all centers and will be in charge of deliverables, data analyses, and results publication. INSERM-Lille will perform DNA microarrays and risk assessments in all recruited newborns.
The FACILITY STUDY is aimed at evaluating maternal and children social, cultural, economic and lifestyle-related risk factors for the development of childhood overweight, obesity and early adiposity rebound (EAR). This study consists of two phases: a cross-sectional phase and a retrospective case-control study.
Childhood obesity has been rising steadily over the past 40 years. In 2016, the World Health Organization (WHO) observed around 340 million overweight or obese children and adolescents worldwide, including one in five in France. The causes are complex, both individual (genetic, biological, behavioral) and collective (social, economic, cultural). Childhood obesity encourages the development of chronic diseases such as diabetes and hypertension, and can affect mental health. Without early treatment, the risk of obesity persisting into adulthood is high. In the Alpes-Maritimes region, the commune of Mouans-Sartoux has been promoting a local diet in line with PNNS-4 recommendations since 2011. We wish to study the impact of these actions on the health of Mouans children. We propose a preliminary observational study to assess the relationship between family adherence to PNNS recommendations and the prevalence of overweight and obesity in Mouans-Sartoux elementary school children.
Food insecurity is associated with obesity in children, and childhood obesity leads to long term health consequences. While existing research shows that food benefit programs reduce food insecurity, little is known about the mediating factors between food benefit programs and child health. The purpose of this study is to understand if the resolution of food insecurity in young children with early onset obesity can improve body mass index (BMI) over one year, and if so, by what mechanisms. The investigators will conduct a randomized comparative effectiveness study among infants (n=228) aged 12 months at risk for food insecurity and deliver two different food security interventions. Both will provide families with $50/week for one year of study enrollment. The first group will receive this as an unrestricted cash benefit ("cash benefit group") and the second group will receive this as a benefit limited to grocery purchases with the support of a trained nutrition expert to guide healthy grocery purchasing ("grocery benefit group"). The investigators will also construct a contemporary comparison cohort of infants meeting the inclusion/exclusion criteria from the electronic health record, using propensity score matching to allow comparisons between both intervention groups and usual care. The primary endpoint is difference in BMI at 12 months post-enrollment (24 months of age). Secondary outcomes include measures of nutrition, food security, electronic health record data related to general child health, and other factors related to parental stress and unmet social needs. Patients will have the opportunity to participate in post-study interviews to report on intervention satisfaction, and facilitators and barriers of infant feeding. Data analysis will be conducted by a trained statistician (Duke Biostatistics, Epidemiology, and Research Design; BERD) and will employ a two-means test for a repeated-measures design. The benefits to participants outweigh the minimal risks of loss of privacy, and confidential information will be managed carefully to minimize this risk.
In this study, betaine intake will be increased in formula-fed infants through formula milk supplementation. To do this, a double-blind randomized study has been designed with the supplementation group (infant formula supplemented with betaine) and control group (unsupplemented infant formula). The main objectives of the study are to determine the safety of supplementation and to assess whether there are changes in infant growth.
Although multidisciplinary treatment of pediatric obesity has shown its effectiveness in leading to weight loss and improvement in the physical, mental and social health of children and adolescents; maintaining these benefits remains a real challenge. Indeed, the literature clearly shows a short- to medium-term increase in weight, the mechanisms of which have yet to be identified in order to prevent it. Although cognitive, behavioral and nutritional adaptations have been highlighted to explain this weight regain, metabolic and energetic adaptations also seem to contribute. Indeed, a reduction in resting and total energy expenditure has been shown (in connection with changes in body composition and in particular lean mass), but also of the energy cost during locomotion and mobility, thus altering the daily energy balance. These energy adaptations are also accompanied by a modification in the use of energy substrates due to a modification of muscular metabolic flexibility in particular, leading to a reduction in lipid oxidation in favor of carbohydrates. Importantly, if this reduction in the use of lipids generates a counterproductive sparing of adipose tissue, thus slowing down weight loss, the increase in carbohydrate oxidation leads to an intensification of orexigenic signals at the central level, promoting nutritional compensations and positive energy balance and therefore contributing to weight regain. Thus, these adaptations of energy metabolism and their interactions with dietary control seem to be at the heart of the mechanisms limiting the success of obesity treatment, favoring weight gain. If these observations were made at the end of treatment programs lasting several weeks to months, a recent clinical work highlights the need to consider the kinetics and temporality of weight loss (weight loss variability and rate of weight loss), so as to identify the crucial stages where these adaptations take place and thus prevent their energy consequences. Thus, the main objective of this project is to study total energy adaptations (energy and nutritional metabolism) at rest but also during locomotion, during the central phase of weight loss of adolescents with obesity, as well as during phases of weight regain. Ultimately, the objective of this study is to better understand energetic adaptations to weight loss and the implication of the degree of weight loss in order to study the role of the interaction between these adaptations and the degree of weight loss on the success of programs and on the profiles of "weight maintainers" or "weight regainers".
The goal of this clinical trial is to compare the effectiveness of a mobile health intervention in adolescents (14-17 years) with overweight or obesity. The main question[s] it aims to answer are: 1) is a digital-based diet quality intervention for adolescents with overweight or obesity feasible and 2) is there preliminary effectiveness in improving diet quality? Participants will: 1. Complete three-day 24-hour dietary recalls 2. Collect urine samples 3. Wear a continuous glucose monitor, sleep tracker, and physical activity tracker Researchers will compare control and intervention groups to see if diet quality and meal timing traits improve as assessed by 24-hour dietary recalls, a novel urine biomarker, and continuous glucose monitoring (CGM).
Adverse childhood experiences (ACEs), referring to traumatic experiences occurring before 18 years of age (e.g., abuse/neglect), are associated with a 30-70% increased risk of developing adolescent and adult obesity and obesity-related cardiometabolic comorbidities, which may be due to dysregulation in stress-related physiology and engagement in stress-related behaviors. While adolescents with ACEs have a 2.25 times increased risk of obesity, standard-of-care lifestyle (e.g., nutrition/physical activity) interventions do not typically incorporate trauma-informed care, including assessment and therapeutic attention to effects of ACEs. Heart rate variability (HRV) biofeedback is an evidence-based, relatively brief, mind-body intervention targeting the stress physiology that can be dysregulated in adolescents with ACEs. The objective of this proposal is to adapt and test a 4-session HRV biofeedback protocol for 12-17-year-olds with BMI>85th percentile and ACEs. First (Phase 1), we will iteratively adapt a 4-session HRV biofeedback facilitator protocol with n=3-5 adolescents with overweight/obesity and ACEs, using adolescent quantitative and qualitative feedback to hone and optimize HRV biofeedback for this population (Aim 1). Next (Phase 2), we will conduct a randomized waitlist-controlled pilot study of n=30 adolescents with overweight/obesity and ACEs to assess acceptability and feasibility (Aim 2) and to describe changes in theorized targets of biofeedback (Aim 3).