NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

Active:	Yes
Cancer Type:	Hematopoietic Malignancies Solid Tumor	NCT ID:	NCT04656496
Trial Phases:		Protocol IDs:	STUDY000244 (primary) NCI-2021-01661 R01CA240319
Eligibility:	5 - 14 Years, Male and Female	Study Type:	Supportive care
Study Sponsor:	University of South Florida
NCI Full Details:	http://clinicaltrials.gov/show/NCT04656496

Summary

Pediatric cancer survivors are at an increased risk of excessive weight gain and reduced
exercise behaviors with the potential for this risk to worsen over time. With over 80% of
pediatric cancer patients living to adulthood, many pediatric cancer survivors experience
long-term health consequences such as heart disease - the leading cause of death in this
population.

The purpose of this clinical research study is to teach parents/caregivers skills that
will help prevent and reduce the problems of obesity in childhood cancer survivors. In
this study, parents have the opportunity to participate in one of two web-based groups in
which parents in either group will learn valuable information to improve the health of
their child and of themselves.

Objectives

This project employs a cluster randomized, controlled, repeated measures trial study
design, with parent-child dyads assigned to an evidence-informed manualized,
social-cognitive parent intervention (NOURISH-T+) or to a comparison group (Enhanced
Usual Care group - Brief NOURISH-T+). NOURISH-T+ stands for Nourishing Our Understanding
of Role modeling to Improve Support and Health for Healthy Transitions.

Parents of pediatric cancer survivors (ages 5-14 years) with overweight and obesity, and
off treatment for at least 6 months will be recruited across multiple pediatric oncology
clinic sites. The University of South Florida (USF) serves as the coordinating data
management and centralized research and intervention team and will also recruit eligible
participants from its pediatric oncology clinic.

NOURISH-T+ targets parents as agents of change by providing intensive parent skills
training emphasizing role modeling of positive health behaviors to foster the development
of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+
group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using
video-conferencing. There will be 2 additional brief sessions where the child will
participate along with their parent to promote child engagement. Additionally, there will
be one session with a pediatric oncology dietician based out of Nicklaus Children's
Hospital who will discuss personalized nutritional strategies. Brief booster sessions at
2-, 4-, 8-, and 10- months will maximize retention and follow-up participation.
NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior
work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight
and obese children).

Parents randomized to Brief NOURISH-T+ will participate in one information session
moderated by a USF-based interventionist using videoconferencing. Session content is
taken from the publicly available We Can! Manual. Parents in this group will receive
nationally available web-based brochures on pediatric overweight/obesity on two occasions
during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take
place at 2-, 4-, 8-, and 10- months post-intervention.

Outcome measures will be completed at baseline, 3-, 6-, and 12-months post-intervention.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.