Clinical Trials

Inclusion Criteria:

• For all participants:

  • Individuals ages 12-17 years

• Additional criteria for adolescents with obesity:

  • BMI ≥ 95^th percentile for age and gender based on CDC growth charts

Exclusion Criteria:

• Principal investigator discretion

• Non-English-speaking caregivers and/or individuals

• Individuals who are unable to sign consent or assent (e.g., those declared legally incompetent)

• Pregnancy

• Diabetes mellitus (type 1 or type 2)

• Current or prior use (within 6 months) of anti-obesity medications (GLP-1 receptor agonists, phentermine, topiramate)

• History of bariatric surgery

• Secondary causes of obesity such as syndromic/monogenic causes, hypothalamic obesity, Cushing’s syndrome

• Ongoing use of any medications that can affect weight or appetite including stimulants, glucocorticoids, antipsychotics and antiseizure medications.

• Participants with food allergies or sensitivities that would prevent them from safely following the study’s dietary interventions

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/01/2026. Questions regarding updates should be directed to the study team contact.