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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 14
Healthy Volunteers: f
View:

‣ Eligible Pediatric Cancer Survivors must be:

⁃ 5-14 years of age at enrollment;

⁃ Off active treatment for at least 6 months;

⁃ At or above the 85th BMI %ile;

⁃ Able to complete assessments with the help of clinic staff and the USF research team;

⁃ Residing with the participating parent;

⁃ Able to engage in PA tailored to current medical status;

⁃ NOT taking medications that affect body weight (e.g., steroids) within 6 months of enrollment, and

⁃ In remission -- PCS who experience a relapse of cancer during the intervention will be excused from further involvement.

⁃ 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

Locations
United States
Washington, D.c.
Children's National Hospital
RECRUITING
Washington D.c.
Florida
University of Florida Health System
RECRUITING
Gainesville
Nicklaus Children's Hospital
SUSPENDED
Miami
University of Miami Health System
RECRUITING
Miami
USF Pediatrics
SUSPENDED
Tampa
Georgia
Emory University
RECRUITING
Atlanta
Maryland
Johns Hopkins Medicine
RECRUITING
Baltimore
Missouri
Washington University School of Medicine
RECRUITING
St Louis
New Jersey
Hackensack Meridian Health
RECRUITING
Hackensack
Virginia
Virginia Commonwealth University
SUSPENDED
Richmond
Contact Information
Primary
Marilyn Stern, PhD
mstern1@usf.edu
813-974-0966
Backup
Flandra Ismajli, BSW
flandraismaj@usf.edu
813-974-6135
Time Frame
Start Date: 2020-12-08
Estimated Completion Date: 2025-11-30
Participants
Target number of participants: 520
Treatments
Experimental: NOURISH-T+
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).
Active_comparator: EUC - Brief NOURISH-T+
The EUC condition (Brief NOURISH-T+) engages parents 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.
Authors
Haneen Abdella
Related Therapeutic Areas
Sponsors
Leads: University of South Florida
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov