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.

Public Health Relevance

Approximately 40-50% of off-treatment pediatric cancer survivors (PCS) are overweight or obese; thereby increasing their risk for negative long-term physical health complications. Using our successful pilot trial testing the preliminary feasibility and efficacy of NOURISH-for Healthy Transitions (NOURISH-T, 5R21CA167259) as a base, we address obesity in PCS by targeting parents as agents for change in modeling healthy eating and physical activity behaviors to promote positive PCS health behavior change and long-term healthy weight. This multi-site application addresses the public health epidemic of obesity by conducting a randomized control trial to test the efficacy of our intervention, NOURISH-T+, across a diverse sample of PCS and their parents at four pediatric oncology clinics, with the goal of establishing a framework for future translation and dissemination of NOURISH-T+.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA240319-02
Application #
10063501
Study Section
Psychosocial Development, Risk and Prevention Study Section (PDRP)
Program Officer
Agurs-Collins, Tanya
Project Start
2019-12-01
Project End
2025-11-30
Budget Start
2020-12-01
Budget End
2021-11-30
Support Year
2
Fiscal Year
2021
Total Cost
Indirect Cost
Name
University of South Florida
Department
Other Health Professions
Type
Schools of Arts and Sciences
DUNS #
069687242
City
Tampa
State
FL
Country
United States
Zip Code
33617