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

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Summer Harvest Adventure
My Summer Plate (MSP)
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring obesity, youth, garden, diet, produce

Eligibility Criteria

8 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Summer Harvest Adventure (SHA)

My Summer Plate (MSP)

Arm Description

Remote nutrition counseling, weekly produce harvesting, group nutrition education

Nutrition education packet

Outcomes

Primary Outcome Measures

Produce intake
Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Ramon Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3)

Secondary Outcome Measures

Weight
Change in weight will be recorded with a precision of 0.1 kilogram
Family engagement
Change in family engagement as assessed by the Expressed Emotion Adjective Checklist
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
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
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

Full Information

First Posted
May 3, 2022
Last Updated
May 9, 2022
Sponsor
Ohio State University
Collaborators
Nationwide Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05367674
Brief Title
Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities
Acronym
SHA
Official Title
Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
August 31, 2021 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Nationwide Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
obesity, youth, garden, diet, produce

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Phase 2 prospective randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Clinical assessments for both groups (intervention and control) will be conducted by trained personnel that are blinded to participants' treatment arm assignment.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Summer Harvest Adventure (SHA)
Arm Type
Experimental
Arm Description
Remote nutrition counseling, weekly produce harvesting, group nutrition education
Arm Title
My Summer Plate (MSP)
Arm Type
Active Comparator
Arm Description
Nutrition education packet
Intervention Type
Behavioral
Intervention Name(s)
Summer Harvest Adventure
Intervention Description
Biobehavioral intervention focusing on nutrition and lifestyle behaviors.
Intervention Type
Behavioral
Intervention Name(s)
My Summer Plate (MSP)
Intervention Description
My Summer Plate (MSP)
Primary Outcome Measure Information:
Title
Produce intake
Description
Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Ramon Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3)
Time Frame
Baseline and 10 weeks
Secondary Outcome Measure Information:
Title
Weight
Description
Change in weight will be recorded with a precision of 0.1 kilogram
Time Frame
Baseline and 10 weeks
Title
Family engagement
Description
Change in family engagement as assessed by the Expressed Emotion Adjective Checklist
Time Frame
Baseline and 10 weeks
Title
Blood Pressure
Description
Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain BP readings
Time Frame
Baseline and 10 weeks
Title
Height
Description
Change in standing height will be measured to the nearest 1 mm using a standardized fixed stadiometer with a vertical backboard and moveable headboard
Time Frame
Baseline and 10 weeks
Title
BMI percentile
Description
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
Time Frame
Baseline and 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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