This study will randomize children who have difficulty maintaining a healthy weight to one of two treatment groups: lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo.
This pilot study will enroll up to 40 children aged 6 to 12 years who have severe obesity. Individuals will be randomized to receive lifestyle therapy plus lisdexamfetamine or lifestyle therapy plus placebo. Participants will receive therapy for 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Vyvanse treatment
Lifestyle treatment
University of Minnesota
Minneapolis, Minnesota, United States
Percent change in Body Mass Index
The primary outcome is the percent change in body mass index (BMI) from randomization to Week 24
Time frame: 24 weeks
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