120 Participants Needed

Remote Monitoring for Childhood Obesity

KS
Overseen ByKarl Sylvester, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help kids and teens with obesity by using wearable gadgets like fitness trackers and glucose monitors to understand how their bodies use insulin and how this affects their heart and overall health. Participants will either undergo bariatric surgery or consider medication called GLP-1, which helps manage obesity, while researchers monitor their activity and glucose levels. Kids and teens with severe obesity who are part of Stanford's Adolescent Bariatric Program and are open to wearing these devices during the study may be a good fit. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve obesity management for young people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that remote monitoring for managing obesity in children is safe and effective. One study found that a structured telehealth program can safely and sustainably help manage obesity in kids. This technology tracks health data from a distance without causing harm and can be used over time.

Another study compared remote monitoring to traditional methods and found it to be a cost-effective way to manage obesity in teenagers, working well without causing problems.

For treatments involving weight-loss surgery and a specific type of medication, devices will closely monitor participants' blood sugar and physical activity. This ensures their safety throughout the study. While these treatments are still being tested, researchers carefully monitor them to catch any potential issues early.12345

Why are researchers excited about this trial?

Researchers are excited about the Remote Monitoring Program for childhood obesity because it offers a novel way to integrate technology into patient care. Unlike traditional methods like dietary changes, physical activity, or medication, this program uses continuous glucose monitoring and fitness tracking to provide real-time data on a child's health. This approach allows for more personalized and timely interventions, potentially improving outcomes by tailoring strategies to individual needs and encouraging more active participation in their health journey.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

This trial will compare different approaches to managing childhood obesity, including a remote monitoring program. Research has shown that remote monitoring programs can effectively manage childhood obesity. One study found that online programs for lifestyle changes worked as well as in-person programs for children. Another study showed that using a mobile app for six months helped reduce obesity in kids, with benefits observed at both six and twelve months. These remote systems track activity and sugar levels to better understand and manage health. Overall, evidence supports that remote monitoring can improve health outcomes in children with obesity.34678

Are You a Good Fit for This Trial?

This trial is for children and teens who are dealing with obesity. It aims to understand how their bodies use insulin and maintain heart and metabolic health. Participants will need to wear fitness trackers and glucose monitors.

Inclusion Criteria

I am willing to wear a continuous glucose monitor and a physiological monitor during the study.
I am eligible for weight loss surgery or GLP1 therapy at Stanford Children's.
My BMI classifies me as having class 2 or 3 obesity.

Exclusion Criteria

Unable to read, understand, or complete the informed consent in English or Spanish
Hypothalamic and syndromic obesity
BMI > 55
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative/Pre-medication Monitoring

Participants undergo continuous glucose monitoring and fitness tracking before surgery or starting GLP-1 therapy

3-4 weeks

Early Treatment Phase

Continuous monitoring during early treatment phase, either perioperative or after 3-4 weeks of GLP-1 use

3-4 weeks

Postoperative/Post-medication Monitoring

Continuous monitoring 3 months post-operatively or after dose stabilization or discontinuation

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Remote Monitoring Program

Trial Overview

The study is testing a new index using data from wearable devices and glucose monitors, combined with lab tests, to see how physical activity levels and blood sugar control relate to metabolic health in young people with obesity.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: GLP-1Experimental Treatment1 Intervention
Group II: Bariatric SurgeryExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Effectiveness of Telehealth and Wearable Device-Based ...

The data on the prevalence of overweight and obesity in children (five to 19 years) from 1990 to 2022 shows a substantial increase. In 1990 ...

Evaluating the long-term effectiveness of a structured ...

Evaluating the long-term effectiveness of a structured telehealth obesity program in children and adolescents: A retrospective matched-control study.

Evaluating the Effectiveness of a Family-Based Virtual ...

Conclusions: The study findings suggested that the virtual GH program was as effective as the blended program for improving child lifestyle ...

Remote Patient Monitoring in Pediatric Obesity

The goal of this study is to examine the feasibility and efficacy of a remote patient monitoring system for children who are obese. Detailed Description.

Effectiveness of Smartphone App for the Treatment ...

This study aims at evaluating the effectiveness of a six-month intervention with a mobile app for the treatment of pediatric obesity at 6 and 12 months of ...

Outcomes Associated With Remote Patient Monitoring for ...

A postdischarge RPM program for infants with PWG was associated with improved attendance of WCVs, fewer outpatient ill visits (eg, weight checks) ...

Mobile Health Is a Cost‐Effective Strategy for Managing ...

This study compared outcomes between using remote monitoring and traditional monitoring during the maintenance phase of adolescent obesity ...

Design, Implementation, and Examination of a Remote ...

This study describes the design and methods of an open trial pilot study to examine a remote patient monitoring system (RPMS) for children aged 8-17 years.