Grant Number:	5R01CA240319-04 Interpret this number
Primary Investigator:	Stern, Marilyn
Organization:	University Of South Florida
Project Title:	NOURISH-T+: a Randomized Control Trial Targeting Parents in Promoting Healthy Eating and Exercise Behaviors in Pediatric Cancer Survivors with Overweight/Obesity
Fiscal Year:	2023

Project Summary There is an unmet need for interventions that address overweight/obesity in pediatric cancer survivors (PCS) after treatment. Rates of overweight and obesity for off-treatment pediatric cancer survivors (PCS) are higher than in the general pediatric population, ranging from 40% to 50%, significantly increasing their risk for concomitant negative health consequences. By the time survivors reach young adulthood they are 10.8 times more likely to have cardiovascular disease than healthy siblings. Reducing the risk of adult obesity in PCS who are overweight or obese by promoting healthy dietary and physical activity (PA) behaviors may serve an important preventive function for these survivors. We recently evaluated the feasibility of our intervention, NOURISH for Healthy Transitions (NOURISH-T), for PCS with obesity by targeting parents as agents for change. Results demonstrated that NOURISH-T was not only feasible, but showed promise of efficacy. We further refined our intervention, now referred to as NOURISH-T+, and implement these in this larger, multi-site RCT, with the aim of evaluating the efficacy of our intervention across diverse pediatric oncology clinics. We focus on parents to model healthy eating and PA behaviors to promote PCS behavior change. Topics relevant to parents of PCS (e.g., transitioning to survivorship and late effects) are discussed. Parents of PCS with overweight/obesity (BMI > 85th%ile), age 5-11, 1- <5 years off treatment will be randomly assigned to the NOURISH-T+ intervention or Enhanced Usual Care (EUC) comparison. Parents in NOURISH-T+ participate in a 6-session, manualized intervention, with an additional dietician session and 2 PCS sessions, as well as post- intervention booster sessions. Sessions are conducted via a videoconferencing platform. EUC consists of a one-time informational session, nationally available brochures and follow-up check-ins. Parents and PCS are assessed on anthropometric measures, PA and dietary behaviors at baseline, 3-, 6-, and 12-months post-intervention. We will enroll a highly diverse group of 260 parents/PCS dyads from Johns Hopkins Medical Center (JH), Nicklaus Children’s Hospital, Miami Children’s Health Care System (MC), Johns Hopkins/All Children’s Hospital (ACH), and Virginia Commonwealth University (VCU). University of South Florida (USF) serves as the coordinating center for intervention, data management and analyses. • Aim 1a: Evaluate NOURISH-T+ for its impact on the primary outcome of child BMI z-score. • Aim 1b: Evaluate NOURISH-T+ on secondary outcomes: PCS waist-to-hip-ratio (WHR), PA and eating behaviors. • Aim 2: Evaluate the impact of NOURISH-T+ on parents, including BMI, WHR, PA and eating behaviors, and perceptions of child-family eating and PA practices. • Exploratory Aim: Evaluate potential moderators of the intervention and examine the dyadic relations between parents and children.





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