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

NCT ID: NCT05367674

Last Updated: 2022-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2022-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 2 prospective randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Clinical assessments for both groups (intervention and control) will be conducted by trained personnel that are blinded to participants' treatment arm assignment.

Study Groups

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Summer Harvest Adventure (SHA)

Remote nutrition counseling, weekly produce harvesting, group nutrition education

Group Type EXPERIMENTAL

Summer Harvest Adventure

Intervention Type BEHAVIORAL

Biobehavioral intervention focusing on nutrition and lifestyle behaviors.

My Summer Plate (MSP)

Nutrition education packet

Group Type ACTIVE_COMPARATOR

My Summer Plate (MSP)

Intervention Type BEHAVIORAL

My Summer Plate (MSP)

Interventions

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Summer Harvest Adventure

Biobehavioral intervention focusing on nutrition and lifestyle behaviors.

Intervention Type BEHAVIORAL

My Summer Plate (MSP)

My Summer Plate (MSP)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Colleen Spees

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36457073 (View on PubMed)

Other Identifiers

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2016-11075

Identifier Type: -

Identifier Source: org_study_id

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