NOURISH-T+: Promoting Healthy Eating and Exercise Behaviors

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer, Obesity, Childhood, Survivorship

Intervention / Treatment
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* Behavioral: NOURISH-T+
* Behavioral: Brief NOURISH-T+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible Pediatric Cancer Survivors must be: 5-14 years of age at enrollment; Off active treatment for at least 6 months; At or above the 85th BMI %ile; Able to complete assessments with the help of clinic staff and the USF research team; Residing with the participating parent; Able to engage in PA tailored to current medical status; NOT taking medications that affect body weight (e.g., steroids) within 6 months of enrollment, and In remission -- PCS who experience a relapse of cancer during the intervention will be excused from further involvement. 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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOURISH-T+<br>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). | Behavioral: NOURISH-T+<br>* 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.<br>|
| Active Comparator: EUC - Brief NOURISH-T+<br>The EUC condition (Brief NOURISH-T+) engages parents 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. | Behavioral: Brief NOURISH-T+<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child BMI z-score | Height and weight will be measured to obtain BMI z-score for gender and age. | 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. | baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | baseline to 12 months | 
| Change in Parent BMI | Height and weight will be measured and used to calculate continuous adult BMI score. | baseline to 6 months | 
| Change in Parent BMI | Height and weight will be measured and used to calculate continuous adult BMI score. | baseline to 12 months |