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Spots Global Cancer Trial Database for NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

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Trial Identification

Brief Title: NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

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

Study ID: NCT04656496

Study Description

Brief 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.

Detailed Description: This project employs a cluster randomized, controlled, repeated measures trial study design, with parent-child dyads assigned to an evidence-informed manualized, social-cognitive parent intervention (NOURISH-T+) or to a comparison group (Enhanced Usual Care group - Brief NOURISH-T+). NOURISH-T+ stands for Nourishing Our Understanding of Role modeling to Improve Support and Health for Healthy Transitions. Parents of pediatric cancer survivors (ages 5-14 years) with overweight and obesity, and off treatment for at least 6 months will be recruited across multiple pediatric oncology clinic sites. The University of South Florida (USF) serves as the coordinating data management and centralized research and intervention team and will also recruit eligible participants from its pediatric oncology clinic. NOURISH-T+ targets parents as agents of change by providing intensive parent skills training emphasizing role modeling of positive health behaviors to foster the development of healthy eating and physical activity in pediatric cancer survivors. The NOURISH-T+ group will have 6 weekly, 1-1.5 hour, manualized sessions delivered using video-conferencing. There will be 2 additional brief sessions where the child will participate along with their parent to promote child engagement. Additionally, there will be one session with a pediatric oncology dietician based out of Nicklaus Children's Hospital who will discuss personalized nutritional strategies. Brief booster sessions at 2-, 4-, 8-, and 10- months will maximize retention and follow-up participation. NOURISH-T+ content is theory-based, manualized, and builds upon strengths of our prior work with NOURISH-T (our pilot) and NOURISH (our work with otherwise healthy overweight and obese children). Parents randomized to Brief NOURISH-T+ will participate in one information session moderated by a USF-based interventionist using videoconferencing. Session content is taken from the publicly available We Can! Manual. Parents in this group will receive nationally available web-based brochures on pediatric overweight/obesity on two occasions during the 6 weeks that NOURISH-T+ families participate in the study. Check-ins will take place at 2-, 4-, 8-, and 10- months post-intervention. Outcome measures will be completed at baseline, 3-, 6-, and 12-months post-intervention.

Keywords

Eligibility

Minimum Age: 5 Years

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: No

Locations

Children's National Hospital, Washington, 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, Saint Louis, Missouri, United States

Hackensack Meridian Health, Hackensack, New Jersey, United States

Virginia Commonwealth University, Richmond, Virginia, United States

Contact Details

Name: Marilyn Stern, PhD

Affiliation: University of South Florida

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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