RECRUITING

NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-12-08
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04656496

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 14 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. 1. 5-14 years of age at enrollment;
  2. 2. Off active treatment for at least 6 months;
  3. 3. At or above the 85th BMI %ile;
  4. 4. Able to complete assessments with the help of clinic staff and the USF research team;
  5. 5. Residing with the participating parent;
  6. 6. Able to engage in PA tailored to current medical status;
  7. 7. NOT taking medications that affect body weight (e.g., steroids) within 6 months of enrollment, and
  8. 8. In remission -- PCS who experience a relapse of cancer during the intervention will be excused from further involvement.
  9. 9. Must be English- or Spanish-speaking
  10. * Be either biological or adoptive and/or step mothers or fathers and must be permanent legal guardians of the PCS
  11. * Be at least 18 years old
  12. * Identifies as the main meal preparer at home
  13. * Must be English- or Spanish-speaking
  1. * Parents are ineligible if they are non-ambulatory and/or do not reside at least 50% of the time with their participating child.
  2. * Female parents who are currently pregnant will be excluded from the study.
  3. * 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.

Contacts and Locations

Study Contact

Marilyn Stern, PhD
CONTACT
813-974-0966
mstern1@usf.edu
Flandra Ismajli, BSW
CONTACT
813-974-6135
flandraismaj@usf.edu

Principal Investigator

Marilyn Stern, PhD
PRINCIPAL_INVESTIGATOR
University of South Florida

Study Locations (Sites)

Children's National Hospital
Washington, District of Columbia, 20010
United States
University of Florida Health System
Gainesville, Florida, 32611
United States
University of Miami Health System
Miami, Florida, 33136
United States
Nicklaus Children's Hospital
Miami, Florida, 33155
United States
USF Pediatrics
Tampa, Florida, 33612
United States
Emory University
Atlanta, Georgia, 30322
United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Hackensack Meridian Health
Hackensack, New Jersey, 07601
United States
Virginia Commonwealth University
Richmond, Virginia, 23298
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Marilyn Stern, PhD, PRINCIPAL_INVESTIGATOR, University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-08
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2020-12-08
Study Completion Date2025-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity, Childhood
  • Cancer
  • Survivorship