Pediatric Healthy Weight Index at Stanford
Official title: Stanford Pediatric Healthy Weight Index
Run by Stanford University · NCT07316816 · Data updated 2026-11-12
This project will test whether a simple score made from wearable activity trackers, continuous glucose monitors, and lab tests can show how well children and teens with obesity use insulin and their overall heart and metabolic health while they start surgery or GLP‑1 therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 18 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Stanford University Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Status | Recruiting |
| Started | January 5, 2026 |
| Main results expected | December 2030 |
| Study ends | December 2030 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT07316816 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adolescents with class 2 or 3 obesity seen in Stanford Children's adolescent bariatric program who are eligible for sleeve gastrectomy or starting GLP‑1 therapy and willing to wear a continuous glucose monitor and a physiological activity monitor are ideal candidates.
✕Probably not a fit
Patients with hypothalamic or syndromic obesity, BMI over 55, prior bariatric surgery, recent GLP treatment (within 3 months), plans for non‑sleeve bariatric procedures, or those unable to consent/complete materials in English or Spanish or unwilling to wear the devices are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective cohort of adolescents with class 2 or 3 obesity who are being evaluated for sleeve gastrectomy or starting GLP‑1 receptor agonist therapy. Participants will wear a fitness tracker and a continuous glucose monitor at three time points: before surgery or treatment, early in treatment (about 3–4 weeks), and roughly three months after surgery or after dose stabilization. Investigators will combine continuous glucose and activity data with laboratory measures to develop a simple index of insulin sensitivity and cardiometabolic fitness. The goal is to relate real‑world activity and glucose patterns to standard metabolic markers to inform clinical decision making.
Why it matters
Potential benefit: If successful, the index could give clinicians an easy-to-read score from wearable and glucose data to track insulin sensitivity and cardiometabolic health and help tailor treatment for adolescents with severe obesity.
How similar studies have gone: Adult studies and some pediatric work have linked continuous glucose monitoring and wearables to metabolic outcomes, but a simple validated pediatric insulin‑sensitivity and cardiometabolic index like this remains largely novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Lucile Packard Children's Hospital - Stanford
Palo Alto, California, United States Recruiting
Study contacts
- Study coordinator: Karl Sylvester, MD
- Email: karls@stanford.edu
- Phone: 650-723-6439
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.