Clinical trial

NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

Active, not recruiting ยท Not applicable ยท 1 countries ยท Registry ID NCT04656496

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age5 Years to 14 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Childhood, Cancer, Survivorship

Full registry 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.

Treatments and study arms

NOURISH-T+

Behavioral

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.

Brief NOURISH-T+

Behavioral

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.

Primary outcomes

Change in Child BMI z-scorebaseline to 6 months

Height and weight will be measured to obtain BMI z-score for gender and age.

Change in Child BMI z-scorebaseline to 12 months

Height and weight will be measured to obtain BMI z-score for gender and age.

Study locations

10 locations were listed when this page was built. The first 40 are shown.

Emory University๐Ÿ‡บ๐Ÿ‡ธ Atlanta, Georgia, United States
Johns Hopkins Medicine๐Ÿ‡บ๐Ÿ‡ธ Baltimore, Maryland, United States
University of Florida Health System๐Ÿ‡บ๐Ÿ‡ธ Gainesville, Florida, United States
Hackensack Meridian Health๐Ÿ‡บ๐Ÿ‡ธ Hackensack, New Jersey, United States
Nicklaus Children's Hospital๐Ÿ‡บ๐Ÿ‡ธ Miami, Florida, United States
University of Miami Health System๐Ÿ‡บ๐Ÿ‡ธ Miami, Florida, United States
Virginia Commonwealth University๐Ÿ‡บ๐Ÿ‡ธ Richmond, Virginia, United States
Washington University School of Medicine๐Ÿ‡บ๐Ÿ‡ธ St Louis, Missouri, United States
USF Pediatrics๐Ÿ‡บ๐Ÿ‡ธ Tampa, Florida, United States
Children's National Hospital๐Ÿ‡บ๐Ÿ‡ธ Washington D.C., District of Columbia, United States