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Childhood ObesitySHANCT05367674

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

A study testing Summer Harvest Adventure and My Summer Plate (MSP) in people with Childhood Obesity, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 8 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
What is being tested?
Summer Harvest Adventure and My Summer Plate (MSP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteUnited States
Study dates
1 Mar 2017to 31 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

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.

Read the 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.

Being tested
Summer Harvest Adventure, My Summer Plate (MSP)
Keywords
obesity, youth, garden, diet, produce
Medical subject headings
Pediatric Obesity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Summer Harvest AdventureBehavioural

    Biobehavioral intervention focusing on nutrition and lifestyle behaviors.

  • My Summer Plate (MSP)Behavioural

    My Summer Plate (MSP)

Study groups in NCT05367674
Study groupRoleWhat they receive
Summer Harvest Adventure (SHA)ExperimentalRemote nutrition counseling, weekly produce harvesting, group nutrition education
Receives: Behavioral: Summer Harvest Adventure
My Summer Plate (MSP)Active comparatorNutrition education packet
Receives: Behavioral: My Summer Plate (MSP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Produce Intake

    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.

    Measured: Baseline and 10 weeks

Secondary outcomes (5)

  1. Weight

    Change in weight will be recorded with a precision of 0.1 kilogram (kg)

    Measured: Baseline and 10 weeks

  2. Family Engagement

    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).

    Measured: Baseline and 10 weeks

  3. Blood Pressure

    Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain blood pressure readings

    Measured: Baseline and 10 weeks

  4. 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

    Measured: Baseline and 10 weeks

  5. 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

    Measured: Baseline and 10 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 May 2022
  2. Study start1 Mar 2017
  3. Primary completion31 Aug 2021
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 2 prospective randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05367674
Sponsor's protocol ID
2016-11075
Other IDs
2016
Acronym
SHA
Status last verified
Feb 2026
First submitted
3 May 2022
Last updated
30 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 40886942

  • 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.

    PubMed 36981636

  • 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.

    PubMed 36471397

  • 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.

    PubMed 36457073

  • 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.

    PubMed 33866297

Questions about this trial

What is this clinical trial studying?

A study testing Summer Harvest Adventure and My Summer Plate (MSP) in people with Childhood Obesity, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Produce Intake (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05367674, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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