This trial is evaluating whether Remote Patient Monitoring will improve 2 primary outcomes and 9 secondary outcomes in patients with Pediatric Obesity. Measurement will happen over the course of Post-Treatment (3 months).
This trial requires 94 total participants across 2 different treatment groups
This trial involves 2 different treatments. Remote Patient Monitoring is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.
Increasing numbers of children and adolescents are obese, particularly girls. The number will increase with time. The rate is higher than previously indicated. The health threats caused by pediatric obesity should be stressed.
The major environmental risk factor for childhood obesity is parental weight status. Increasing overweight children and adolescents are usually overweight parents. Pediatric obesity is a growing epidemic with increasing rates in the USA, Canada, and other nations. This poses a crisis and a public health imperative with a substantial economic burden and considerable public health consequences. Early identification and treatment of childhood obesity and obesity-associated disorders will likely prove detrimental in this growing population.
While it is clear that obesity is a disease, there is currently no FDA-approved drug for obesity, and treatment options have been limited. Further research into effective treatment of obesity is needed, especially considering the high numbers of pediatric patients with obesity. Studies involving bariatric surgery are recommended as a therapeutic approach against pediatric obesity.
Obesity in children and adolescents may be treated with a combination of dietary, exercise, and/or medication management. The most common medications used are ophthalmic medications such as eye drops and nasal sprays.\n
Few trials have been reported on the use of remote patient monitoring and the quality of most of the reported evidence is poor. Despite this, evidence appears to favor its use.
Most of the pediatric drugs are well studied both in children and in adult populations. In those studies, the adverse events occurring in the pediatric trial populations are similar to those reported in adult trial populations. Only a few drugs appear to have increased tolerability in children compared with adults. However, it is impossible to say whether greater tolerability of a drug will translate into a positive clinical outcome for pediatric subjects because of the heterogeneity of pediatric patients. There is a need for a better understanding of pediatric safety profiles of drugs and for trials with pediatric subjects that reflect the unique pharmacological properties and physiological conditions associated with children.
Remote monitoring is safe and associated with a high compliance rate. Common side effects are uncommon to the magnitude and pattern in the pediatric group compared with adults. The most common serious side effect is hypoalbuminemia. The side effects and side effect management are similar among adults and children.
Data from a recent study show that the overall technology in the field of remote patient monitoring is changing and the possibilities it offers are changing accordingly. A new generation in remote patient monitoring should provide a high quality of care enabling us to take advantage of this technology as it appears to be in the future.
Although [there is no evidence to show that RPM improved overall survival, it did lead to better patient safety in this population with complex health-care needs.