NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors
Hematopoietic Malignancies
Solid Tumor
5 - 14 Years, Male and Female
STUDY000244 (primary)
NCI-2021-01661
R01CA240319
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.
Eligibility
- Inclusion Criteria:
Eligible Pediatric Cancer Survivors must be:
1. 5-14 years of age at enrollment;
2. Off active treatment for at least 6 months;
3. At or above the 85th BMI %ile;
4. Able to complete assessments with the help of clinic staff and the USF research team;
5. Residing with the participating parent;
6. Able to engage in PA tailored to current medical status;
7. NOT taking medications that affect body weight (e.g., steroids) within 6 months of
enrollment, and
8. In remission -- PCS who experience a relapse of cancer during the intervention will be
excused from further involvement.
9. Must be English- or Spanish-speaking
Participating Parents must:
- Be either biological or adoptive and/or step mothers or fathers and must be permanent
legal guardians of the PCS
- Be at least 18 years old
- Identifies as the main meal preparer at home
- Must be English- or Spanish-speaking
Exclusion Criteria:
- Parents are ineligible if they are non-ambulatory and/or do not reside at least 50% of
the time with their participating child.
- Female parents who are currently pregnant will be excluded from the study.
- Children are ineligible to participate if they are non-ambulatory. In addition,
children who are wards of the state will be excluded from the study.
Treatment Sites in Georgia
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