RecruitingNot ApplicableNCT04656496

NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

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


Sponsor

University of South Florida

Enrollment

520 participants

Start Date

Dec 8, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 5 YearsMax Age: 14 Years

Inclusion Criteria15

  • 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

Exclusion Criteria3

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALNOURISH-T+

NOURISH-T+ (Nourishing Our Understanding of Role Modeling to Improve Support and Healthy - Transitions) is a 6 session, psychoeducational program designed to teach parents of childhood cancer survivors with overweight/obesity knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.

BEHAVIORALBrief NOURISH-T+

Enhanced Usual Care (or Brief NOURISH-T+) is an abbreviated version of the full NOURISH-T+ intervention in which parents are engaged in a one-time information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.


Locations(10)

Children's National Hospital

Washington D.C., District of Columbia, United States

University of Florida Health System

Gainesville, Florida, United States

University of Miami Health System

Miami, Florida, United States

Nicklaus Children's Hospital

Miami, Florida, United States

USF Pediatrics

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Johns Hopkins Medicine

Baltimore, Maryland, United States

Washington University School of Medicine

St Louis, Missouri, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

Virginia Commonwealth University

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04656496


Related Trials