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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
520
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.
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.
Children's National Hospital
Washington D.C., District of Columbia, United States
RECRUITINGUniversity of Florida Health System
Gainesville, Florida, United States
RECRUITINGUniversity of Miami Health System
Miami, Florida, United States
RECRUITINGNicklaus Children's Hospital
Miami, Florida, United States
SUSPENDEDUSF Pediatrics
Tampa, Florida, United States
SUSPENDEDEmory University
Atlanta, Georgia, United States
RECRUITINGJohns Hopkins Medicine
Baltimore, Maryland, United States
RECRUITINGWashington University School of Medicine
St Louis, Missouri, United States
RECRUITINGHackensack Meridian Health
Hackensack, New Jersey, United States
RECRUITINGVirginia Commonwealth University
Richmond, Virginia, United States
SUSPENDEDChange in Child BMI z-score
Height and weight will be measured to obtain BMI z-score for gender and age.
Time frame: baseline to 6 months
Change in Child BMI z-score
Height and weight will be measured to obtain BMI z-score for gender and age.
Time frame: baseline to 12 months
Change in Child Physical Activity Behaviors
Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time.
Time frame: baseline to 6 months
Change in Child Physical Activity Behaviors
Waist-worn accelerometers will be worn for one week to calculate average daily step count over one week. Accelerometers objectively measure daily PA, including average steps per day, time spent in moderate-vigorous activity, and sedentary time.
Time frame: baseline to 12 months
Change in Child Eating Behaviors
Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations.
Time frame: baseline to 6 months
Change in Child Eating Behaviors
Dietary Recall Automated Self-administered 24-Hour Dietary Recall-2020(ASA24). ASA24 is a highly reliable, computer assisted 24-hour dietary recall interview with animated guides and audio and visual cues to instruct participants and enhance use in low-literacy populations.
Time frame: baseline to 12 months
Change in Parent BMI
Height and weight will be measured and used to calculate continuous adult BMI score.
Time frame: baseline to 6 months
Change in Parent BMI
Height and weight will be measured and used to calculate continuous adult BMI score.
Time frame: baseline to 12 months
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