Remote Patient Monitoring for Pediatric Obesity

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Mississippi Medical Center, Jackson, MS
Pediatric Obesity+1 More
Remote Patient Monitoring - Behavioral
Eligibility
< 18
All Sexes
Eligible conditions
Pediatric Obesity

Study Summary

This study is evaluating whether a remote patient monitoring system can help children who are obese.

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Eligible Conditions

  • Pediatric Obesity
  • Obesity

Treatment Effectiveness

Study Objectives

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).

Post-Treatment (3 months)
Feasibility of using the RPMS
Satisfaction with using the RPMS
Month 6
A1c
Blood Pressure
Dietary Intake
Glucose
Health-related Quality of Life
Home food environment
Physical Activity
Self-efficacy
Weight Status

Trial Safety

Trial Design

2 Treatment Groups

Control
Remote Patient Monitoring

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.

Remote Patient Monitoring
Behavioral
Families participating in the study will receive standard medical care as well as the Remote Patient Monitoring System.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remote Patient Monitoring
2012
Completed Phase 1
~440

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: post-treatment (3 months) and follow-up (6 months)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly post-treatment (3 months) and follow-up (6 months) for reporting.

Closest Location

University of Mississippi Medical Center - Jackson, MS

Eligibility Criteria

This trial is for patients born any sex aged 18 and younger. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A child's weight status is considered to be in the obese range if their body mass index is equal to or above the 95th percentile for their age and gender. show original
The parent and the child are both fluent in English. show original
Children aged 8 to 17 who attend an outpatient pediatric obesity clinic visit are at an increased risk for psychological problems, including symptoms of depression and anxiety. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is pediatric obesity?

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The growing problem of obesity in youth and its attendant health risks call for increased efforts to educate caregivers on the importance of preventive activities related to diet and exercise.

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What are the signs of pediatric obesity?

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Signs of pediatric obesity include body dissatisfaction, increased appetite, weight and height disparity, and an increased waist-to-hip ratio. Most of these features occur during the school-age years.

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How many people get pediatric obesity a year in the United States?

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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.

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What causes pediatric obesity?

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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.

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Can pediatric obesity be cured?

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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.

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What are common treatments for pediatric obesity?

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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

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What is the primary cause of pediatric obesity?

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In the setting of the present study, most of the weight gain occurred among overweight children, and the majority of the weight loss was attributable to a change in the distribution of weight throughout the individual child.

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Have there been other clinical trials involving remote patient monitoring?

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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.

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Have there been any new discoveries for treating pediatric obesity?

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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.

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What are the common side effects of remote patient monitoring?

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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.

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What are the latest developments in remote patient monitoring for therapeutic use?

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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.

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Is remote patient monitoring safe for people?

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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.

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