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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04097353
Other study ID # IRB1700469
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 1, 2017
Est. completion date December 31, 2019

Study information

Verified date March 2023
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 31
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 12 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Harvesting Hope for Kids (HH4K)
Weekly meetings at university-based farm
Surviving Strong for Kids (SS4K)
Enhanced usual care

Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio
United States The Ohio State University Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Cynthia Gerhardt Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Month 0 (baseline) to Month 2 (post-intervention)
Primary Change in Physical Activity Daily step count, with higher counts indicating more physical activity Month 0 (baseline) to Month 2 (post-intervention)
Secondary 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 Month 0 (baseline) to Month 2 (post-intervention)
Secondary 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 Month 0 (baseline) to Month 2 (post-intervention)
Secondary 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 Month 0 (baseline) to Month 2 (post-intervention)
Secondary Change in Blood Pressure Lower scores indicate lower cardiometabolic risk Month 0 (baseline) to Month 2 (post-intervention)
Secondary Change in Blood Lipids and Glucose Blood lipids and glucose will provide TC/HDL ratio, non-HDL cholesterol, and LDL cholesterol, with lower scores indicating lower cardiometabolic risk Month 0 (baseline) to Month 2 (post-intervention)
Secondary Change in Microbial Diversity Stool samples will examine microbiome a- and ß- diversity, with higher scores indicating greater microbial diversity Month 0 (baseline) to Month 2 (post-intervention)
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