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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04097353
Study type Interventional
Source Nationwide Children's Hospital
Contact
Status Terminated
Phase N/A
Start date May 1, 2017
Completion date December 31, 2019

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