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Clinical Trial NCT07316816 for Obesity & Overweight is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Stanford UniversityStanford Pediatric Healthy Weight Index 120 Pediatric Wearable Device
Clinical Trial NCT07316816 is an interventional study for Obesity & Overweight that is recruiting. It started on January 5, 2026 with plans to enroll 120 participants. Led by Stanford University, it is expected to complete by December 1, 2030. The latest data from ClinicalTrials.gov was last updated on January 5, 2026.
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...Show More
Official Title
Stanford Pediatric Healthy Weight Index
Conditions
Obesity & OverweightOther Study IDs
- 81022
NCT ID Number
Start Date (Actual)
2026-01-05
Last Update Posted
2026-01-05
Completion Date (Estimated)
2030-12
Enrollment (Estimated)
120
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
Metabolism
Continuous Glucose Monitoring
Obesity
Bariatric Surgery
GLP-1
Continuous Glucose Monitoring
Obesity
Bariatric Surgery
GLP-1
Primary Purpose
Diagnostic
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBariatric 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. | 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. |
ExperimentalGLP-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. | 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. |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
10 Years
Eligible Sexes
All
- 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.
- 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
Stanford University665 active studies to exploreStudy Responsible Party
Karl Sylvester, Principal Investigator, Professor of Surgery, Stanford University
Study Central Contact
Contact: Karl Sylvester, MD, 650-723-6439, [email protected]
1 Study Locations in 1 Countries
California
Lucile Packard Children's Hospital - Stanford, Palo Alto, California, 94304, United States
Elton Ortiz, MS, Contact, 650-723-6439, [email protected]
Elena Harnish, MA, Contact, 650-739-6427, [email protected]
Karl Sylvester, MD, Principal Investigator
Gillian Fell, MD, PhD, Sub-Investigator
Recruiting