- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04097353
Improving Health Behaviors for Pediatric Cancer Survivors
March 10, 2023 updated by: Cynthia Gerhardt
Harvesting Hope for Kids: Improving Diet and Physical Activity in Childhood Cancer Survivors
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
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Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
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Columbus, Ohio, United States, 43210
- The Ohio State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Harvesting Hope for Kids (HH4K)
Eight weekly, 60-minute sessions at a university-based farm with booster sessions.
Learning is structured around fun activities to provide information about the impact of cancer treatment on children's health, as well as the importance of nutrition and physical activity in survivorship.
Each session is manualized and devoted to education, a behavioral strategy applied toward a weekly goal, a cooking demonstration/taste testing, and harvesting produce from the survivor garden.
Modules are offered in a group format with families together.
|
Weekly meetings at university-based farm
|
Sham Comparator: Surviving Strong for Kids (SS4K)
Families assigned to enhanced usual care (SS4K) group will receive education in the form of standardized guidelines for nutrition and physical activity for survivors of childhood cancer.
In a one-hour session, they will learn about the impact of cancer treatment on health and the importance of nutrition and physical activity for survivors.
Families will receive websites for other educational resources.
They will not have access to harvesting, remote coaching, the web portal, or behavioral training to address their child's nutrition or activity.
|
Enhanced usual care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Fruit and Vegetable Intake
Time Frame: 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
|
Month 0 (baseline) to Month 2 (post-intervention)
|
Change in Physical Activity
Time Frame: Month 0 (baseline) to Month 2 (post-intervention)
|
Daily step count, with higher counts indicating more physical activity
|
Month 0 (baseline) to Month 2 (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Child Quality of Life
Time Frame: 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
|
Month 0 (baseline) to Month 2 (post-intervention)
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Change in Parent-rated Child Quality of Life
Time Frame: 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
|
Month 0 (baseline) to Month 2 (post-intervention)
|
Change in Body Mass Index (BMI)
Time Frame: 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
|
Month 0 (baseline) to Month 2 (post-intervention)
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Change in Blood Pressure
Time Frame: Month 0 (baseline) to Month 2 (post-intervention)
|
Lower scores indicate lower cardiometabolic risk
|
Month 0 (baseline) to Month 2 (post-intervention)
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Change in Blood Lipids and Glucose
Time Frame: Month 0 (baseline) to Month 2 (post-intervention)
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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)
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Change in Microbial Diversity
Time Frame: Month 0 (baseline) to Month 2 (post-intervention)
|
Stool samples will examine microbiome α- and β- diversity, with higher scores indicating greater microbial diversity
|
Month 0 (baseline) to Month 2 (post-intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2017
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
September 10, 2019
First Submitted That Met QC Criteria
September 19, 2019
First Posted (Actual)
September 20, 2019
Study Record Updates
Last Update Posted (Actual)
March 13, 2023
Last Update Submitted That Met QC Criteria
March 10, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB1700469
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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