Real world use of anti-obesity medications to treat adolescent obesity: moving beyond the clinical trial

Duke University, Durham NC

Investigators

Abstract

PROJECT SUMMARY/ABSTRACT One in five US adolescents have obesity, making pediatric obesity a significant public health problem. Safe and effective treatment options exist for adolescents with obesity including motivational interviewing, intensive health behavior and lifestyle therapy, pharmacotherapy, and metabolic and bariatric surgery. Recently, several anti- obesity medications (AOMs) have been approved for use in adolescents, showing great promise for reducing obesity. However, to date, these AOMs have only been studied in tightly controlled clinical trials. While clinical trials have high internal validity and provide evidence for efficacy of pharmacological approaches, they are limited in their external validity and real-world generalizability. This has lead to gaps in our understanding of adolescent AOM use including knowledge of the reach of AOMs in youth, effectiveness within real-world clinical settings, and possible unintended consequences of AOM use. It is imperative that these gaps are addressed to ensure that adolescents receive safe and effective clinical care. Therefore, the objective of this project is to collect real- world evidence that can be used to inform clinical practice, improve health outcomes, and ensure patient safety among adolescents using AOMs. The proposed project will recruit a cohort of adolescents using AOMs (12-17y; n=200) from two pediatric obesity treatment clinics. In Aim 1, we will characterize the population of youth using AOMs by examining demographic characteristics from the electronic health record of cohort youth compared to those who are eligible, but never prescribed AOMs. In Aims 2 & 3, cohort participants will be followed for 18- months, completing four study visits that will include measure of body composition, diet, physical activity, mental health and quality of life. A subset of patients will complete DXA scans to further assess changes in body composition and semi-structured interviews to yield richer contextual information. Data will also be obtained from the electronic health record and assessments of adherence throughout the duration of cohort participation. In Aim 2, effectiveness of AOMs will be evaluated by examining change in relative BMI among cohort youth compared to the youth not utilizing AOMs from Aim 1 using propensity weighting approaches. Additional analyses will examine the relationship between changes in diet, physical activity and study outcomes as well describe adherence to AOM treatment protocols including medication switching and discontinuation. In Aim 3, we will consider the unintended consequences of AOM use including longitudinal changes in mental health, development of disordered eating behavior, and changes in DXA measured body composition and bone mineral density. Overall, this project will provide valuable clinical evidence around AOM use in adolescents by addressing key gaps in our knowledge of access, effectiveness and factors that influence effectiveness, and potential unintended consequences. Successful completion of this project will inform clinical recommendations around adolescent AOM use and has broader implications for implementation of AOMs among specialized obesity treatment centers and general pediatric clinics.