Study Design and Procedures
This is a multi-center pilot study consisting of a six-month dietary
intervention. Participants were recruited from Children’s Hospital of
Philadelphia (Philadelphia, PA), Children’s National Hospital
(Washington, DC), Roswell Park Comprehensive Cancer Center (Buffalo,
NY), and Columbia University Irving Medical Center (New York, NY) from
June 2017 through August 2019. Dietary intake and anthropometric
measurements were obtained at study entry (diagnosis), end of induction
(approximately 30 days from initiation of treatment), and end of month
six of treatment. The study was approved by the institutional review
boards at all participating centers and was performed in accordance with
the Helsinki Declaration. The trial was registered with
clinicaltrials.gov (NCT03157323).