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

Childhood Obesity Clinical Trial

— SHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367674
• Other study ID #: 2016-11075
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 31, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Summer Harvest Adventure
Biobehavioral intervention focusing on nutrition and lifestyle behaviors.
• My Summer Plate (MSP)
My Summer Plate (MSP)

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight	Change in weight will be recorded with a precision of 0.1 kilogram	Baseline and 10 weeks
Secondary	Family engagement	Change in family engagement as assessed by the Expressed Emotion Adjective Checklist	Baseline and 10 weeks
Secondary	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
Secondary	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
Secondary	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