The objective of this study is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers.
Advances in treatment have led to a rapidly growing population of over 388,500 survivors, with 13,500 new survivors expected annually. However, chronic or long-term side effects (e.g., secondary malignancies, metabolic syndrome, cardio-pulmonary toxicities) can reduce quality of life and lead to premature death. The investigators propose that diet and fitness are two critical factors for healthy survivorship given their broad impact on late effects like obesity, fatigue, and metabolic syndrome. Despite the promise of comprehensive lifestyle interventions for children who are overweight or obese, research with survivors is limited by small samples and inconsistent effects. Novel research supports a key role for the gastrointestinal (GI) microbiome in regulating weight and health outcomes, yet no studies have examined the "obesogenic" microbiome in the context of lifestyle interventions for survivors of childhood cancer. The objective of this RCT is to examine the efficacy of Harvesting Hope for Kids (HH4K), a biobehavioral intervention delivered in the context of a university-based, cancer survivor garden, to increase produce intake and physical activity in survivors and caregivers. Families will be randomized to participate in HH4K or enhanced usual care. Dietary patterns, physical activity, cardiometabolic indices, family outcomes, and GI microbiome will be assessed and the HH4K group will demonstrate greater improved than enhanced usual care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
31
Weekly meetings at university-based farm
Enhanced usual care
Nationwide Children's Hospital
Columbus, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Change in Fruit and Vegetable Intake
Skin carotenoid score, with total scores ranging from 10,000-89,000+ and higher scores indicating more fruit and vegetable intake
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Physical Activity
Daily step count, with higher counts indicating more physical activity
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Child Quality of Life
Children will complete the Pediatric Quality of Life Inventory (PedsQL), with total scores ranging from 0-92 and subscale scores ranging from 0-20/32; Higher scores indicate better quality of life
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Parent-rated Child Quality of Life
Parents will complete the Pediatric Quality of Life Inventory (PedsQL) for parents, with total scores ranging from 0-92 and subscale scores ranging from 0-20/32; Higher scores indicate better quality of life
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Body Mass Index (BMI)
Height, weight, and age will be combined to report BMI in kg/m\^2, with lower scores indicating lower cardiometabolic risk
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Blood Pressure
Lower scores indicate lower cardiometabolic risk
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Blood Lipids and Glucose
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Blood lipids and glucose will provide TC/HDL ratio, non-HDL cholesterol, and LDL cholesterol, with lower scores indicating lower cardiometabolic risk
Time frame: Month 0 (baseline) to Month 2 (post-intervention)
Change in Microbial Diversity
Stool samples will examine microbiome α- and β- diversity, with higher scores indicating greater microbial diversity
Time frame: Month 0 (baseline) to Month 2 (post-intervention)