Clinical trial NCT05367674: Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities
Official title: Summer Harvest Adventure: A Garden-based Obesity Prevention Program for Children Residing in Low-resource Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: obesity
youth
garden
diet
produce
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2022-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 2 prospective randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Produce intake
timeFrame: Baseline and 10 weeks
Secondary outcomes:
measure: Weight
timeFrame: Baseline and 10 weeks
measure: Family engagement
timeFrame: Baseline and 10 weeks
measure: Blood Pressure
timeFrame: Baseline and 10 weeks
measure: Height
timeFrame: Baseline and 10 weeks
measure: BMI percentile
timeFrame: Baseline and 10 weeks
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References: