Improving Health Behaviors for Pediatric Cancer Survivors

NCT04097353 | Terminated

• 1 other identifier: IRB1700469
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer

Keywords

Behavioral; Obesity; Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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)

• Change in Physical Activity

  Daily step count, with higher counts indicating more physical activity

  Month 0 (baseline) to Month 2 (post-intervention)

Secondary Outcomes (6)

• Change in Child Quality of Life

  Month 0 (baseline) to Month 2 (post-intervention)

• Change in Parent-rated Child Quality of Life

  Month 0 (baseline) to Month 2 (post-intervention)

• Change in Body Mass Index (BMI)

  Month 0 (baseline) to Month 2 (post-intervention)

• Change in Blood Pressure

  Month 0 (baseline) to Month 2 (post-intervention)

• Change in Blood Lipids and Glucose

  Month 0 (baseline) to Month 2 (post-intervention)

Study Arms (2)

Harvesting Hope for Kids (HH4K)

EXPERIMENTAL

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.

Behavioral: Harvesting Hope for Kids (HH4K)

Surviving Strong for Kids (SS4K)

SHAM COMPARATOR

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.

Behavioral: Surviving Strong for Kids (SS4K)

Interventions

Harvesting Hope for Kids (HH4K) BEHAVIORAL

Weekly meetings at university-based farm

Harvesting Hope for Kids (HH4K)

Surviving Strong for Kids (SS4K) BEHAVIORAL

Enhanced usual care

Surviving Strong for Kids (SS4K)

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• significant developmental disorder or cognitive difficulties that would interfere with children and caregivers completing questionnaires
• Referral to hospice or at end of life.

Sponsors & Collaborators

• Cynthia Gerhardt: lead
• Ohio State University: collaborator

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Neoplasms; Behavior; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cynthia Gerhardt, PhD

  Abigail Wexner Research Institute at Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 20, 2019
• Study Start: May 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 13, 2023

Record last verified: 2023-03

Locations

US (2)