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

Study Overview
=================
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.

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

Conditions
-----------------
Childhood Obesity

Intervention / Treatment
-----------------
* Behavioral: Summer Harvest Adventure
* Behavioral: My Summer Plate (MSP)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase 2 prospective randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Summer Harvest Adventure (SHA)<br>Remote nutrition counseling, weekly produce harvesting, group nutrition education | Behavioral: Summer Harvest Adventure<br>* Biobehavioral intervention focusing on nutrition and lifestyle behaviors.<br>|
| Active Comparator: My Summer Plate (MSP)<br>Nutrition education packet | Behavioral: My Summer Plate (MSP)<br>* My Summer Plate (MSP)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | Change in weight will be recorded with a precision of 0.1 kilogram | Baseline and 10 weeks | 
| Family engagement | Change in family engagement as assessed by the Expressed Emotion Adjective Checklist | Baseline and 10 weeks | 
| 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 | Baseline and 10 weeks | 
| 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 | Baseline and 10 weeks | 
| 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 | Baseline and 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, youth, garden, diet, produce