- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05367674
Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities (SHA)
June 20, 2026 updated by: Colleen Spees, PhD, RD, FAND, FAHA, Ohio State University
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
Intervention / Treatment
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)
192
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
-
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 11 years (Child)
Accepts Healthy Volunteers
Yes
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
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Summer Harvest Adventure (SHA)
Remote nutrition counseling, weekly produce harvesting, group nutrition education
|
Biobehavioral intervention focusing on nutrition and lifestyle behaviors.
|
|
Active Comparator: My Summer Plate (MSP)
Nutrition education packet
|
My Summer Plate (MSP)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Produce Intake
Time Frame: Baseline and 10 weeks
|
Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Raman Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3).
Dermal skin carotenoid scores range 10,000-85,000, with higher scores indicating higher skin carotenoid levels.
|
Baseline and 10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Height
Time Frame: Baseline and 10 weeks
|
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
|
|
Weight
Time Frame: Baseline and 10 weeks
|
Change in weight will be recorded with a precision of 0.1 kilogram (kg)
|
Baseline and 10 weeks
|
|
Family Engagement
Time Frame: Baseline and 10 weeks
|
Change in family engagement as assessed by the Expressed Emotion Adjective Checklist.
The Expressed Emotion Adjective Checklist (EEAC) is a self-reported measure of expressed emotions.
Twenty items are summed to a total score (range 20-140); higher scores indicate more positive expressed emotion (better outcome).
|
Baseline and 10 weeks
|
|
Blood Pressure
Time Frame: Baseline and 10 weeks
|
Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain blood pressure readings
|
Baseline and 10 weeks
|
|
BMI Percentile
Time Frame: Baseline and 10 weeks
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Loman B, Hill E, Bailey M, et al. A High-Fiber Diet Intervention Improves Diet Quality and Is Related to Blood Pressure and Bacteriome Composition in Caregiver-Child Dyads. Curr Dev Nutr. 2021;5(Suppl 2):1168. Published 2021 Jun 7. doi:10.1093/cdn/nzab054_023
- Gao S, Chen L, Zhang H, Khalsa AS, Bailey MT, Loman BR, Spees CK, Zhu J. Comparing and optimizing protein extraction methods with different lysis buffers for the analyses of human fecal microbiome via metaproteomics approach. J Microbiol Methods. 2025 Oct;237:107244. doi: 10.1016/j.mimet.2025.107244. Epub 2025 Aug 29.
- Braun A, Portner J, Xu M, Weaver L, Pratt K, Darragh A, Spees CK. Preliminary Support for the Use of Motivational Interviewing to Improve Parent/Adult Caregiver Behavior for Obesity and Cancer Prevention. Int J Environ Res Public Health. 2023 Mar 7;20(6):4726. doi: 10.3390/ijerph20064726.
- Khalsa AS, Burton J, Bailey MT, Zhu J, Kelleher KJ, Maltz RM, Loman BR, Spees CK. Collection of biospecimens from parent-child dyads in a community garden-based nutrition intervention: protocol and feasibility. BMC Nutr. 2022 Dec 5;8(1):141. doi: 10.1186/s40795-022-00640-6.
- Hill EB, Chen L, Bailey MT, Singh Khalsa A, Maltz R, Kelleher K, Spees CK, Zhu J, Loman BR. Facilitating a high-quality dietary pattern induces shared microbial responses linking diet quality, blood pressure, and microbial sterol metabolism in caregiver-child dyads. Gut Microbes. 2022 Jan-Dec;14(1):2150502. doi: 10.1080/19490976.2022.2150502.
- Chen L, Sun X, Khalsa AS, Bailey MT, Kelleher K, Spees C, Zhu J. Accurate and reliable quantitation of short chain fatty acids from human feces by ultra high-performance liquid chromatography-high resolution mass spectrometry (UPLC-HRMS). J Pharm Biomed Anal. 2021 Jun 5;200:114066. doi: 10.1016/j.jpba.2021.114066. Epub 2021 Apr 6.
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)
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)
June 30, 2026
Last Update Submitted That Met QC Criteria
June 20, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
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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