Medication + Lifestyle Changes for Adolescent Severe Obesity
(SMART Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will examine the timing and sequence of using adjunct obesity pharmacotherapy for adolescents with severe obesity who do not respond to lifestyle modification therapy alone.
Who Is on the Research Team?
Claudia Fox, MD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for teens aged 12-17 with severe obesity who haven't improved with lifestyle changes alone. They must be willing to use effective contraception if sexually active, and commit to the study's duration. Exclusions include diabetes, heart conditions, certain mental health issues, untreated thyroid disorders, previous weight loss surgery or medication use.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lifestyle Modification Therapy (LSMT)
Participants start with a lifestyle modification program to assess initial weight loss response
Pharmacotherapy Addition
Participants who do not achieve a 5% BMI reduction add phentermine to LSMT
Advanced Pharmacotherapy
Participants who do not achieve a 5% BMI reduction with phentermine are randomized to additional medication regimens
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Phentermine Pill
- Topiramate Pill
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator