Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities (SHA)

The objective of this study is to implement and test the efficacy of the "Summer Harvest Adventure," a comprehensive garden-based behavioral, social, and environmental intervention for children (ages 8-11 years) residing in low-resource communities.

Study Overview

• Status: Completed
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Summer Harvest Adventure; Behavioral: My Summer Plate (MSP)

Detailed Description

The investigators will conduct a 2-arm randomized controlled trial designed to determine the efficacy of a multifaceted obesity prevention and lifestyle intervention in low-resource children and parent/adult caregiver (PAC) called "Summer Harvest Adventure." A total of 240 children (ages 8-11 years) will be randomized to the garden-based intervention (SHA) or an enhanced control group (MSP). Summer Harvest Adventure includes: 1) remote and group coaching using a focused motivational interviewing approach; 2) weekly fruit, vegetable, and herb harvesting to increase summer food access; and 3) group education for children and their families in a social setting. Assessments for both groups will be collected at orientation held one week prior to the intervention (week 0), and immediately following the completion of the intervention (week 10) by trained personnel that are blinded to participants' treatment arm assignment.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children 8-11 years of age (as of June 1) from assenting and consenting families
• English-speaking families that agree to participate; 3) residents of SNAP-eligible communities in Franklin County, Ohio.

Exclusion Criteria:

• Inability to functionally participate in harvesting; accommodations can be implemented in the future for children with special needs
• Communication difficulties (e.g. severe developmental delay)
• Lack of transportation to weekly classes or harvesting activities
• Non-English speakers; because coaching and classroom-based education are all conducted in English, we will of necessity restrict to English-speakers only during this phase

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Summer Harvest Adventure (SHA); Remote nutrition counseling, weekly produce harvesting, group nutrition education	Behavioral: Summer Harvest Adventure; Biobehavioral intervention focusing on nutrition and lifestyle behaviors.
Active Comparator: My Summer Plate (MSP); Nutrition education packet	Behavioral: My Summer Plate (MSP); My Summer Plate (MSP)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Produce intake	Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Ramon Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3)	Baseline and 10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Change in weight will be recorded with a precision of 0.1 kilogram	Baseline and 10 weeks
Family engagement	Change in family engagement as assessed by the Expressed Emotion Adjective Checklist	Baseline and 10 weeks
Blood Pressure	Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain BP readings	Baseline and 10 weeks
Height	Change in standing height will be measured to the nearest 1 mm using a standardized fixed stadiometer with a vertical backboard and moveable headboard	Baseline and 10 weeks
BMI percentile	BMI will be calculated using weight (kg) divided by the square of height (m). BMI-for-age percentile growth charts will be used to measure the size and growth patterns of children in the study	Baseline and 10 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 10, 2022

Study Record Updates

• Last Update Posted (Actual): May 10, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: obesity; diet; youth; garden; produce
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2016-11075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No