NCT05367674

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

4.5 years

First QC Date

May 3, 2022

Last Update Submit

May 9, 2022

Conditions

Childhood Obesity

Keywords

obesityyouthgardendietproduce

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Weight

    Baseline and 10 weeks

  • Family engagement

    Baseline and 10 weeks

  • Blood Pressure

    Baseline and 10 weeks

  • Height

    Baseline and 10 weeks

  • BMI percentile

    Baseline and 10 weeks

Study Arms (2)

Summer Harvest Adventure (SHA)

EXPERIMENTAL

Remote nutrition counseling, weekly produce harvesting, group nutrition education

Behavioral: Summer Harvest Adventure

My Summer Plate (MSP)

ACTIVE COMPARATOR

Nutrition education packet

Behavioral: My Summer Plate (MSP)

Interventions

Summer Harvest AdventureBEHAVIORAL

Biobehavioral intervention focusing on nutrition and lifestyle behaviors.

Summer Harvest Adventure (SHA)
My Summer Plate (MSP)BEHAVIORAL

My Summer Plate (MSP)

My Summer Plate (MSP)

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 36457073DERIVED

MeSH Terms

Conditions

Pediatric ObesityObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Clinical assessments for both groups (intervention and control) will be conducted by trained personnel that are blinded to participants' treatment arm assignment.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Phase 2 prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 10, 2022

Study Start

March 1, 2017

Primary Completion

August 31, 2021

Study Completion

March 31, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)