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Spots Global Cancer Trial Database for Improving Health Behaviors for Pediatric Cancer Survivors

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Improving Health Behaviors for Pediatric Cancer Survivors

Official Title: Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors

Study ID: NCT04097353

Conditions

Cancer

Study Description

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.

Eligibility

Minimum Age: 8 Years

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: Yes

Locations

Nationwide Children's Hospital, Columbus, Ohio, United States

The Ohio State University, Columbus, Ohio, United States

Contact Details

Name: Cynthia Gerhardt, PhD

Affiliation: Abigail Wexner Research Institute at Nationwide Children's Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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