Stanford Pediatric Healthy Weight Index

NCT ID: NCT07316816

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-05
• Study Completion Date: 2030-12-31

Brief Summary

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.

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.

Conditions

Obesity & Overweight

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Remote Monitoring Program

Intervention Type: OTHER

Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.

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.

Group Type: EXPERIMENTAL

Remote Monitoring Program

Intervention Type: OTHER

Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Karl Sylvester

Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Lucile Packard Children's Hospital - Stanford

Palo Alto, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Karl Sylvester, MD

Role: CONTACT

karls@stanford.edu

650-723-6439

Facility Contacts

Elton Ortiz, MS

Role: primary

elton@stanford.edu

650-723-6439

Elena Harnish, MA

Role: backup

eharnish@stanford.edu

650-739-6427

Other Identifiers

81022

Identifier Type: -

Identifier Source: org_study_id