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

Award Number: R01CA240319
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2019
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $318,794 )
2025	2025	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	001	6	6/10/2025	NON-COMPETING CONTINUATION	$31,879
2025	2025	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	000	6	12/4/2024	NON-COMPETING CONTINUATION	$286,915
														Subtotal = $318,794

Issue Date FY: 2024 ( Subtotal = $549,098 )
2024	2024	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	001	5	12/22/2023	SUPPLEMENT FOR EXPANSION	$74,367
2024	2024	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	002	5	4/17/2024	NON-COMPETING CONTINUATION	$24,768
2024	2024	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	003	5	4/23/2024	SUPPLEMENT FOR EXPANSION	$4,131
2024	2024	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	000	5	11/30/2023	NON-COMPETING CONTINUATION	$445,832
														Subtotal = $549,098

Issue Date FY: 2023 ( Subtotal = $637,375 )
2023	2023	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	000	4	1/26/2023	NON-COMPETING CONTINUATION	$502,326
2023	2023	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	001	4	1/30/2023	SUPPLEMENT FOR EXPANSION	$135,049
														Subtotal = $637,375

Issue Date FY: 2022 ( Subtotal = $583,033 )
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	001	3	5/26/2022	NON-COMPETING CONTINUATION	$42,786
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	000	3	11/30/2021	NON-COMPETING CONTINUATION	$481,334
2022	2022	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	002	3	8/23/2022	SUPPLEMENT FOR EXPANSION	$58,913
														Subtotal = $583,033

Issue Date FY: 2021 ( Subtotal = $189,384 )
2021	2021	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	000	2	12/1/2020	NON-COMPETING CONTINUATION	$160,442
2021	2021	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	001	2	2/2/2021	NON-COMPETING CONTINUATION	$28,942
														Subtotal = $189,384

Issue Date FY: 2020 ( Subtotal = $591,149 )
2020	2020	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	001	1	2/3/2020	NEW	$13,347
2020	2020	UNIVERSITY OF SOUTH FLORIDA	4202 E FOWLER AVE	TAMPA	FL	33620	HILLSBOROUGH	USA	Cancer Detection and Diagnosis Research	000	1	11/27/2019	NEW	$577,802
														Subtotal = $591,149

Grand Total All Awards = $2,868,833

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

Award Number: R01CA240319

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/01/2019

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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