James G Waxmonsky1, William E Pelham7, Adriana Campa3, Daniel A Waschbusch4, Tan Li3, Rebecca Marshall5, Lysett Babocsai6, Hugh Humphery5, Elizabeth Gnagy7, James Swanson8, Tomasz Hanć9, Negar Fallahazad3, William E Pelham7. 1. Penn State College of Medicine, Hershey, Pennsylvania. Electronic address: jwaxmonsky@pennstatehealth.psu.edu. 2. Arizona State University, Tempe. 3. Robert Stempel College of Public Health and Social Work, Florida International University, Miami. 4. Penn State College of Medicine, Hershey, Pennsylvania. 5. Herbert Wertheim College of Medicine, Florida International University, Miami. 6. University of Heidelberg, Germany. 7. Florida International University, Miami. 8. School of Medicine, University of California, Irvine. 9. Adam Mickiewicz University, Poznan, Poland.
Abstract
OBJECTIVE: To examine the impact of central nervous system (CNS) stimulants on the growth of children with attention-deficit/hyperactivity disorder (ADHD), and to assess the efficacy and feasibility of weight recovery interventions on growth. METHOD: A total of 230 children aged 5 to 12 years with ADHD with no history of chronic CNS stimulant use were randomly assigned to receive daily CNS stimulants (78%, primarily osmotic release oral system-methylphenidate [OROS-MPH]) or behavioral treatment (22%) for 30 months. After 6 months, children evidencing a decline in body mass index (BMI) of >0.5 z-units were randomized to 1 of 3 weight recovery treatments (WRTs): monthly monitoring of height/weight (MON) plus continued daily medication; drug holidays (DH) with medication limited to school days; or daily caloric supplementation (CS) with a 150-kcal supplement plus daily medication. RESULTS: Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p values <.01). Adherence to CS and DH during WRT was high, with significant increases in daily caloric intake and decreases in weekly medication exposure (p values <.05). Across all WRT participants (n = 71), weight velocity increased significantly after WRT randomization (β2 = 0.271, SE = 0.027, p < .001).When analyzed by what parents did (versus what they were assigned to), CS (p < .01) and DH (p < .05) increased weight velocity more than MON. No increase in height velocity was seen after randomization to any WRT. Over the entire study, WRT participants declined in standardized weight (-0.44 z-units) and height (-0.20 z-units). CONCLUSION: Drug holidays, caloric supplementation, and increased monitoring all led to increased weight velocity in children taking CNS stimulants, but none led to increased height velocity. CLINICAL TRIAL REGISTRATION INFORMATION: Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth; https://clinicaltrials.gov/; NCT01109849.
RCT Entities:
OBJECTIVE: To examine the impact of central nervous system (CNS) stimulants on the growth of children with attention-deficit/hyperactivity disorder (ADHD), and to assess the efficacy and feasibility of weight recovery interventions on growth. METHOD: A total of 230 children aged 5 to 12 years with ADHD with no history of chronic CNS stimulant use were randomly assigned to receive daily CNS stimulants (78%, primarily osmotic release oral system-methylphenidate [OROS-MPH]) or behavioral treatment (22%) for 30 months. After 6 months, children evidencing a decline in body mass index (BMI) of >0.5 z-units were randomized to 1 of 3 weight recovery treatments (WRTs): monthly monitoring of height/weight (MON) plus continued daily medication; drug holidays (DH) with medication limited to school days; or daily caloric supplementation (CS) with a 150-kcal supplement plus daily medication. RESULTS: Before WRT assignment, medication was associated with significant reductions in standardized weight and height (p values <.01). Adherence to CS and DH during WRT was high, with significant increases in daily caloric intake and decreases in weekly medication exposure (p values <.05). Across all WRT participants (n = 71), weight velocity increased significantly after WRT randomization (β2 = 0.271, SE = 0.027, p < .001).When analyzed by what parents did (versus what they were assigned to), CS (p < .01) and DH (p < .05) increased weight velocity more than MON. No increase in height velocity was seen after randomization to any WRT. Over the entire study, WRT participants declined in standardized weight (-0.44 z-units) and height (-0.20 z-units). CONCLUSION: Drug holidays, caloric supplementation, and increased monitoring all led to increased weight velocity in children taking CNS stimulants, but none led to increased height velocity. CLINICAL TRIAL REGISTRATION INFORMATION: Novel Approach to Stimulant Induced Weight Suppression and Its Impact on Growth; https://clinicaltrials.gov/; NCT01109849.
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