Stanford Pediatric Healthy Weight Index
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote Monitoring Program.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight. Basic parameters: 10 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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
- Percent Reduction in BMI [Time frame: baseline through study completion, an average of 4 months]
- Body Weight [Time frame: baseline through study completion, an average of 4 months]
- Fasting Glucose [Time frame: baseline through study completion, an average of 4 months]
- Fasting Insulin [Time frame: baseline through study completion, an average of 4 months]
- HbA1c [Time frame: baseline through study completion, an average of 4 months]
- Lipid Panel [Time frame: baseline through study completion, an average of 4 months]
- Liver Enzymes [Time frame: baseline through study completion, an average of 4 months]
Secondary outcome measures (1)
- Obesity-related Comorbidities [Time frame: baseline through study completion, an average of 4 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Lucile Packard Children's Hospital - Stanford — Palo Alto
Identifiers
NCT: NCT07316816 · 81022