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NCT Number: NCT07316816

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.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital - Stanford

Palo Alto, California, 94304, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Percent Reduction in BMI

    Time frame: baseline through study completion, an average of 4 months

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

  2. Body Weight

    Time frame: baseline through study completion, an average of 4 months

    Change in body weight (kg)

  3. Fasting Glucose

    Time frame: baseline through study completion, an average of 4 months

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

  4. Fasting Insulin

    Time frame: baseline through study completion, an average of 4 months

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

  5. HbA1c

    Time frame: baseline through study completion, an average of 4 months

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

  6. Lipid Panel

    Time frame: baseline through study completion, an average of 4 months

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

  7. Liver Enzymes

    Time frame: baseline through study completion, an average of 4 months

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

Secondary outcomes

  1. Obesity-related Comorbidities

    Time frame: baseline through study completion, an average of 4 months

    Defined as resolution or improvement according to prespecified clinical criteria

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Jan 5, 2026
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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