NOURISH-T+: A Randomized Control Trial Targeting Parents in Promoting Healthy Eating and Exercise Behaviors in Pediatric Cancer Survivors with Overweight/Obesity

NIH Pandemic-Era Grants

Pandemic Era Grants

2024

Document text

Principal Investigator: Marilyn  Stern
Organization: UNIVERSITY OF SOUTH FLORIDA
Fiscal Year: 2024
Award: $470,600
Funding agency: National Cancer Institute

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.

Terms: <0-11 years old><Accelerometer><Active Follow-up><Address><Adherence><Adverse Late Effects><After Care><After-Treatment><Aftercare><Age><BMI><BMI percentile><BMI z-score><Behavior><Behavioral><Blinded><Body Weight decreased><Body mass index><Booklets><Brochures><Caloric Intake><Cancer Treatment><Cardiovascular Diseases><Characteristics><Child><Child Youth><Child health care><Childhood><Childhood Cancer Treatment><Children (0-21)><Children's Hospital><Chronic Disease><Chronic Illness><Clinic><Collaborations><Data><Data Analyses><Data Analysis><Diabetes Mellitus><Dietary Assessment><Eating><Eating Behavior><Effectiveness of Interventions><Energy Intake><Enrollment><Exercise><Family><Fats><Fatty acid glycerol esters><Florida><Food Intake><Frequencies><Future><Goals><Health><Health Care Systems><Health behavior change><Healthcare Systems><Healthy Eating><Height><History><Hour><Intake><Intervention><Intervention Strategies><Investigators><Late Effects><Maintenance><Malignant Neoplasm Therapy><Malignant Neoplasm Treatment><Manuals><Measures><Medical center><Metabolic syndrome><Modeling><Obesity><Obesity Epidemic><Outcome><Over weight><Overweight><Pamphlets><Parents><Participant><Patient Recruitments><Patient Self-Report><Pediatric Cancer Treatment><Pediatric Hospitals><Pediatric Oncology><Perception><Physical activity><Population><Preventive><Public Health><Quetelet index><Randomized><Randomized, Controlled Trials><Recording of previous events><Reporting><Research><Research Personnel><Researchers><Risk><Risk Reduction><Sampling><Self-Report><Siblings><Site><Survivors><Testing><Time><Translations><Universities><Videoconferencing><Virginia><Vulnerable Populations><Waist-Hip Ratio><Weight><Weight Gain><Weight Increase><Weight Loss><Weight Reduction><Work><accelerometry><acceptability and feasibility><active followup><activity monitor><activity tracker><adiposity><adult adiposity><adult obesity><adult youth><adults with obesity><ages><anti-cancer therapy><assess effectiveness><base><bases><behavior change><body weight gain><body weight increase><body weight loss><caloric dietary content><cancer therapy><cancer-directed therapy><cardiovascular disorder><care as usual><child adiposity><child healthcare><child obesity><childhood adiposity><childhood cancer survivor><childhood obesity><chronic disorder><clinical practice><corpulence><data interpretation><data management><determine effectiveness><determine efficacy><diabetes><dietary><effectiveness assessment><effectiveness evaluation><efficacy analysis><efficacy assessment><efficacy determination><efficacy evaluation><efficacy examination><efficacy testing><enroll><ethnic diversity><ethnically diverse><evaluate effectiveness><evaluate efficacy><examine effectiveness><examine efficacy><follow up><follow-up><followed up><followup><healthy weight><high risk group><high risk individual><high risk people><high risk population><histories><improved><intervention delivery><interventional strategy><kids><modifiable behavior><obese children><obesity during childhood><obesity in children><obesity intervention><obesity risk><obesity therapy><obesity treatment><parent><participant recruitment><pediatric><pediatric cancer survivor><pediatric care><pediatric health care><pediatric healthcare><pediatric obesity><physical conditioning><physical health><pilot trial><post intervention><post treatment><primary outcome><racial diversity><racially diverse><randomisation><randomization><randomized control trial><randomly assigned><recruit><reduce risk><reduce risks><reduce that risk><reduce the risk><reduce these risks><reduces risk><reduces the risk><reducing risk><reducing the risk><risk for obesity><risk of obesity><risk-reducing><role model><secondary outcome><sedentary activity><sugar><survivorship><translation><treatment as usual><usual care><video conferencing><vulnerable group><vulnerable individual><vulnerable people><waist-to-hip ratio><weights><wt gain><wt-loss><young adult><young adulthood><youngster>