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Contemporary Clinical Trials 2015-Mar

Design and rationale for NOURISH-T: a randomized control trial targeting parents of overweight children off cancer treatment.

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Marilyn Stern
Lin Ewing
Esther Davila
Amanda L Thompson
Gregory Hale
Suzanne Mazzeo

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Abstrait

Approximately 40% of off-treatment pediatric cancer survivors (PCS) are overweight or obese, which increases their risk for negative long-term physical health complications. Consistent with the Institute of Medicine's (IOM) emphasis on patients transitioning from treatment to cancer survivorship and increasing long-term healthy behaviors in these survivors, we plan to conduct a pilot RCT to address the increasing overweight/obesity rates among PCS by targeting their caregivers as agents for PCS behavior change. We plan to focus on parents' behaviors, attitudes and roles in promoting healthier eating and physical activity (PA) in PCS and adapt an evidence-informed, manualized parent intervention - NOURISH - found to be effective for parents of overweight and obese children and adolescents in reducing child and adolescent BMI. We plan to adapt NOURISH for caregivers of 5-12 year old PCS (6 months-4 years off active cancer treatment). Our pilot feasibility RCT - NOURISH-T (Nourishing Our Understanding of Role modeling to Improve Support for Healthy Transitions) evaluates: 1) the preliminary efficacy of NOURISH-T for PCS, compared with an Enhanced Usual Care (EUC) control condition, and 2) factors to consider to improve future adaptations of the intervention. The project will enroll caregivers of PCS at two pediatric oncology clinics into the 6-week intervention (or EUC) with assessments occurring pre- and post-6 weeks of intervention, and at a 4-month follow-up.

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