Clinical trial NCT04097353: Improving Health Behaviors for Pediatric Cancer Survivors
Official title: Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: Behavioral
Obesity
Neoplasm
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: Ohio State University
First posted: 2019-09-20
Enrollment: 31
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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 criteria: 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.

Primary outcomes:
measure: Change in Fruit and Vegetable Intake
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
measure: Change in Physical Activity
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
Secondary outcomes:
measure: Change in Child Quality of Life
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
measure: Change in Parent-rated Child Quality of Life
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
measure: Change in Body Mass Index (BMI)
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
measure: Change in Blood Pressure
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
measure: Change in Blood Lipids and Glucose
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
measure: Change in Microbial Diversity
timeFrame: Month 0 (baseline) to Month 2 (post-intervention)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Abigail Wexner Research Institute at Nationwide Children's Hospital
name: Cynthia Gerhardt, PhD
role: PRINCIPAL_INVESTIGATOR
References: