Clinical trial

Stanford Pediatric Healthy Weight Index

Recruiting now · Not applicable · 1 countries · Registry ID NCT07316816

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 18 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight

Full registry 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

Treatments and study arms

Remote Monitoring Program

Other

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

Primary outcomes

Percent Reduction in BMIbaseline through study completion, an average of 4 months

assessment of change in BMI from pre-intervention to post-intervention

Body Weightbaseline through study completion, an average of 4 months

Change in body weight (kg)

Fasting Glucosebaseline through study completion, an average of 4 months

change in fasting glucose levels from pre-intervention to post-intervention

Fasting Insulinbaseline through study completion, an average of 4 months

change in fasting insulin levels from pre-intervention to post-intervention

HbA1cbaseline through study completion, an average of 4 months

change in HbA1c levels from pre-intervention to post-intervention

Lipid Panelbaseline through study completion, an average of 4 months

changes in lipid panel levels from pre-intervention to post-intervention

Liver Enzymesbaseline through study completion, an average of 4 months

changes in liver enzymes from pre-intervention to post-intervention

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Lucile Packard Children's Hospital - Stanford🇺🇸 Palo Alto, California, United States

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Elton Ortiz, MSContact

Email · Call 650-723-6439

Elena Harnish, MAContact

Email · Call 650-739-6427

Karl Sylvester, MDPrincipal Investigator