Stanford Pediatric Healthy Weight Index

This study will develop a simple index to measure how well the body uses insulin and overall heart and metabolic health in children and teens with obesity. The investigators will use data from wearable devices (like fitness trackers) and glucose monitors, along with lab tests, to learn how activity and glucose relate to metabolic problems.

Study Overview

• Status: Recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Other: Remote Monitoring Program

Detailed Description

This is a prospective cohort study to develop a metabolic index for insulin sensitivity and cardiometabolic fitness among children and adolescents with obesity. Adolescent patients undergoing evaluation for bariatric surgery or medical management of wight using GLP-1 agonist therapies will be consented for participation. Participants will be given a wearable fitness device and a continuous glucose monitor. Continuous monitoring will be carried out at three time points: preoperative or prior to starting medication, perioperative or after 3-4 weeks of GLP1 use during early treatment phase, and 3 months post-operatively or 3 months after dose stabilization or discontinuation.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karl Sylvester, MD; Phone Number: 650-723-6439; Email: karls@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Lucile Packard Children's Hospital - Stanford
      • Contact: Elton Ortiz, MS; Phone Number: 650-723-6439; Email: elton@stanford.edu
      • Contact: Elena Harnish, MA; Phone Number: 650-739-6427; Email: eharnish@stanford.edu
      • Principal Investigator: Karl Sylvester, MD
      • Sub-Investigator: Gillian Fell, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Class 2 and 3 obesity
• Patient in the Adolescent Bariatric Program at Stanford Children's that is eligible for either laparoscopic sleeve gastrectomy or GLP1 Receptor Agonist Therapy
• Willingness to wear a CGM and physiological monitor for the duration of the study.

Exclusion Criteria:

• Hypothalamic and syndromic obesity
• BMI > 55
• Plan to undergo bariatric surgical procedure other than sleeve gastrectomy
• Prior bariatric surgical procedure
• Active GLP treatment (within past 3 months)
• Unable to read, understand, or complete the informed consent in English or Spanish

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bariatric Surgery; Adolescent patients in the Adolescent Bariatric Program at Stanford Children's undergoing bariatric surgery will undergo continuous glucose monitoring and fitness tracking throughout the course of study.	Other: Remote Monitoring Program; Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.
Experimental: GLP-1; Adolescent patients being considered for GLP-1 receptor agonist therapy for obesity management will undergo continuous glucose monitoring and fitness tracking throughout the course of study.	Other: Remote Monitoring Program; Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Reduction in BMI	assessment of change in BMI from pre-intervention to post-intervention	baseline through study completion, an average of 4 months
Body Weight	Change in body weight (kg)	baseline through study completion, an average of 4 months
Fasting Glucose	change in fasting glucose levels from pre-intervention to post-intervention	baseline through study completion, an average of 4 months
Fasting Insulin	change in fasting insulin levels from pre-intervention to post-intervention	baseline through study completion, an average of 4 months
HbA1c	change in HbA1c levels from pre-intervention to post-intervention	baseline through study completion, an average of 4 months
Lipid Panel	changes in lipid panel levels from pre-intervention to post-intervention	baseline through study completion, an average of 4 months
Liver Enzymes	changes in liver enzymes from pre-intervention to post-intervention	baseline through study completion, an average of 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obesity-related Comorbidities	Defined as resolution or improvement according to prespecified clinical criteria	baseline through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): January 5, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Actual): January 5, 2026

Study Record Updates

• Last Update Posted (Actual): January 5, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; GLP-1; Continuous Glucose Monitoring; Bariatric Surgery; Metabolism
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 81022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes