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NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors
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.
Conditions:
🦠 Obesity, Childhood 🦠 Cancer 🦠 Survivorship
🗓️ Study Start (Actual) 8 December 2020
🗓️ Primary Completion (Estimated) 30 October 2025
✅ Study Completion (Estimated) 30 November 2025
👥 Enrollment (Estimated) 520
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Washington, District of Columbia, United States
📍 Gainesville, Florida, United States
📍 Miami, Florida, United States
📍 Miami, Florida, United States
📍 Tampa, Florida, United States
📍 Atlanta, Georgia, United States
📍 Baltimore, Maryland, United States
📍 Saint Louis, Missouri, United States
📍 Hackensack, New Jersey, United States
📍 Richmond, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 5 Years to 14 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 12 November 2020
  • First Submitted that Met QC Criteria 30 November 2020
  • First Posted 7 December 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 November 2023
  • Last Update Posted 13 November 2023
  • Last Verified November 2023
I'm interested ...!!