Helping parents promote healthy eating and exercise for childhood cancer survivors

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

This study is testing a program to help parents of childhood cancer survivors learn how to encourage their kids to eat healthier and be more active.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 520 (estimated)
• Ages: 5 Years to 14 Years
• Sex: All
• Sponsor: University of South Florida (Academic / other)
• Locations: 10 sites (Washington, District of Columbia and 9 other locations)
• Trial ID: NCT04656496 on ClinicalTrials.gov

What this trial studies

This clinical research focuses on pediatric cancer survivors who are at risk of obesity and reduced physical activity. It involves a cluster randomized controlled trial where parent-child dyads are assigned to either an intensive parent intervention program (NOURISH-T+) or a comparison group receiving enhanced usual care. The program includes weekly video-conferencing sessions aimed at equipping parents with skills to model healthy behaviors and improve their child's nutrition and activity levels. The study also incorporates sessions with a pediatric dietician to provide personalized nutritional strategies.

Who should consider this trial

Good fit: Ideal candidates are pediatric cancer survivors aged 5-14 years who are off treatment for at least 6 months and have a BMI at or above the 85th percentile.

Not a fit: Patients who are currently taking medications that affect body weight or are non-ambulatory may not benefit from this study.

Why it matters

Potential benefit: If successful, this program could significantly reduce obesity rates and improve overall health outcomes for childhood cancer survivors.

How similar studies have performed: Other studies have shown success in similar interventions targeting lifestyle changes in pediatric populations, indicating potential for positive outcomes in this approach.

Eligibility criteria

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.

Where this trial is running

Washington, District of Columbia and 9 other locations

• Children's National Hospital — Washington, District of Columbia, United States (Recruiting)
• University of Florida Health System — Gainesville, Florida, United States (Recruiting)
• University of Miami Health System — Miami, Florida, United States (Recruiting)
• Nicklaus Children's Hospital — Miami, Florida, United States (Suspended)
• USF Pediatrics — Tampa, Florida, United States (Suspended)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• Johns Hopkins Medicine — Baltimore, Maryland, United States (Recruiting)
• Washington University School of Medicine — Saint Louis, Missouri, United States (Recruiting)
• Hackensack Meridian Health — Hackensack, New Jersey, United States (Recruiting)
• Virginia Commonwealth University — Richmond, Virginia, United States (Suspended)

Study contacts

• Principal investigator: Marilyn Stern, PhD — University of South Florida
• Study coordinator: Marilyn Stern, PhD

Conditions Obesity, Childhood; Cancer; Survivorship