Obesity & OverweightNCT07316816
Stanford Pediatric Healthy Weight Index
A study testing Remote Monitoring Program in people with Obesity & Overweight, run by Stanford University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Remote Monitoring Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Lucile Packard Children's Hospital - Stanford
Palo Alto, California, 94304
Elton Ortiz, MS, 650-723-6439, elton@stanford.edu
Elena Harnish, MA, 650-739-6427, eharnish@stanford.edu
About this study
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.
Read the 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.
- Conditions
- Obesity & Overweight
- Being tested
- Remote Monitoring Program
- Keywords
- Metabolism, Continuous Glucose Monitoring, Obesity, Bariatric Surgery, GLP-1
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Monitoring ProgramOther
Continuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices.
| Study group | Role | What they receive |
|---|---|---|
| Bariatric Surgery | Experimental | 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. Receives: Other: Remote Monitoring Program |
| GLP-1 | Experimental | 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. Receives: Other: Remote Monitoring Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Reduction in BMI
assessment of change in BMI from pre-intervention to post-intervention
Measured: baseline through study completion, an average of 4 months
Body Weight
Change in body weight (kg)
Measured: baseline through study completion, an average of 4 months
Fasting Glucose
change in fasting glucose levels from pre-intervention to post-intervention
Measured: baseline through study completion, an average of 4 months
Fasting Insulin
change in fasting insulin levels from pre-intervention to post-intervention
Measured: baseline through study completion, an average of 4 months
HbA1c
change in HbA1c levels from pre-intervention to post-intervention
Measured: baseline through study completion, an average of 4 months
Lipid Panel
changes in lipid panel levels from pre-intervention to post-intervention
Measured: baseline through study completion, an average of 4 months
Liver Enzymes
changes in liver enzymes from pre-intervention to post-intervention
Measured: baseline through study completion, an average of 4 months
Secondary outcomes (1)
Obesity-related Comorbidities
Defined as resolution or improvement according to prespecified clinical criteria
Measured: baseline through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start5 Jan 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karl Sylvester, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316816
- Sponsor's protocol ID
- 81022
- Status last verified
- Dec 2025
- First submitted
- 8 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stanford Pediatric Healthy Weight Index
- ClinicalTrials.gov ID
- NCT07316816
- Acronym / sponsor ID
- 81022
- Conditions
- Obesity & Overweight
- Keywords
- Metabolism, Continuous Glucose Monitoring, Obesity, Bariatric Surgery, GLP-1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bariatric Surgery | Experimental | Other: Remote Monitoring ProgramAdolescent 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. |
| GLP-1 | Experimental | Other: Remote Monitoring ProgramAdolescent 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Monitoring ProgramContinuous glucose monitors will be placed at 2 or 3 clinically relevant time points and participants will track their fitness using wearable devices. | Other | Bariatric Surgery, GLP-1 |
Primary outcome
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
Body Weight
Time frame: baseline through study completion, an average of 4 months
Change in body weight (kg)
Fasting Glucose
Time frame: baseline through study completion, an average of 4 months
change in fasting glucose levels from pre-intervention to post-intervention
Fasting Insulin
Time frame: baseline through study completion, an average of 4 months
change in fasting insulin levels from pre-intervention to post-intervention
HbA1c
Time frame: baseline through study completion, an average of 4 months
change in HbA1c levels from pre-intervention to post-intervention
Lipid Panel
Time frame: baseline through study completion, an average of 4 months
changes in lipid panel levels from pre-intervention to post-intervention
Liver Enzymes
Time frame: baseline through study completion, an average of 4 months
changes in liver enzymes from pre-intervention to post-intervention
1 secondary outcome
Obesity-related Comorbidities
Time frame: baseline through study completion, an average of 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Monitoring Program in people with Obesity & Overweight, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karl Sylvester, MD (650-723-6439, karls@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Reduction in BMI (time frame: baseline through study completion, an average of 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.