Cancer
Conditions
Keywords
Behavioral, Obesity, Neoplasm
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHarvesting Hope for Kids (HH4K)
Weekly meetings at university-based farm
BEHAVIORALSurviving Strong for Kids (SS4K)
Enhanced usual care
Sponsors
Ohio State University
Cynthia Gerhardt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Families will be randomly assigned to the Harvesting Hope for Kids (HH4K) intervention or the enhanced usual care (Surviving Strong for Kids (SS4K) education group after the baseline assessment.
Eligibility
Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* 8-12 years of age * previously diagnosed with any type of pediatric cancer * within 5 years post-treatment for pediatric cancer * fluent in English, with at least 1 fluent parent * living within 75 miles of the medical center
Exclusion criteria
* significant developmental disorder or cognitive difficulties that would interfere with children and caregivers completing questionnaires * Referral to hospice or at end of life.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fruit and Vegetable Intake | Month 0 (baseline) to Month 2 (post-intervention) | Skin carotenoid score, with total scores ranging from 10,000-89,000+ and higher scores indicating more fruit and vegetable intake |
| Change in Physical Activity | Month 0 (baseline) to Month 2 (post-intervention) | Daily step count, with higher counts indicating more physical activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index (BMI) | Month 0 (baseline) to Month 2 (post-intervention) | Height, weight, and age will be combined to report BMI in kg/m\^2, with lower scores indicating lower cardiometabolic risk |
| Change in Blood Pressure | Month 0 (baseline) to Month 2 (post-intervention) | Lower scores indicate lower cardiometabolic risk |
| Change in Child Quality of Life | Month 0 (baseline) to Month 2 (post-intervention) | 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 |
| Change in Microbial Diversity | Month 0 (baseline) to Month 2 (post-intervention) | Stool samples will examine microbiome α- and β- diversity, with higher scores indicating greater microbial diversity |
| Change in Blood Lipids and Glucose | Month 0 (baseline) to Month 2 (post-intervention) | Blood lipids and glucose will provide TC/HDL ratio, non-HDL cholesterol, and LDL cholesterol, with lower scores indicating lower cardiometabolic risk |
| Change in Parent-rated Child Quality of Life | Month 0 (baseline) to Month 2 (post-intervention) | 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 |
Countries
United States
Outcome results
None listed