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Completed

NCT Number: NCT05367674

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

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.

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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

8 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Summer Harvest Adventure

Behavioral

Biobehavioral intervention focusing on nutrition and lifestyle behaviors.

My Summer Plate (MSP)

Behavioral

My Summer Plate (MSP)

Primary outcomes

  1. Produce Intake

    Time frame: Baseline and 10 weeks

    Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Raman Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3). Dermal skin carotenoid scores range 10,000-85,000, with higher scores indicating higher skin carotenoid levels.

Secondary outcomes

  1. Weight

    Time frame: Baseline and 10 weeks

    Change in weight will be recorded with a precision of 0.1 kilogram (kg)

  2. Family Engagement

    Time frame: Baseline and 10 weeks

    Change in family engagement as assessed by the Expressed Emotion Adjective Checklist. The Expressed Emotion Adjective Checklist (EEAC) is a self-reported measure of expressed emotions. Twenty items are summed to a total score (range 20-140); higher scores indicate more positive expressed emotion (better outcome).

  3. Blood Pressure

    Time frame: Baseline and 10 weeks

    Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain blood pressure readings

  4. Height

    Time frame: Baseline and 10 weeks

    Change in standing height will be measured to the nearest 1 mm using a standardized fixed stadiometer with a vertical backboard and moveable headboard

  5. BMI Percentile

    Time frame: Baseline and 10 weeks

    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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Acronym: SHA

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
May 10, 2022
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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