- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02166034
Effects of School Gardens on Children's Diet, Nutritional Knowledge, Etc. (HGHY)
June 15, 2014 updated by: Cornell University
Healthy Gardens, Healthy Youth (HGHY): A People's Garden School Pilot Program
The purpose of this study is to determine whether school gardens influence children's dietary intake, nutritional knowledge, and other outcomes.
Study Overview
Detailed Description
Schools in New York, Washington State, Iowa, and Arkansas were randomly assigned to receive school gardens and associated curriculum or to serve on the wait list control group that received gardens and curriculum at the end of the 2-year study.
Baseline data were collected in Fall 2011.
Garden interventions began in Spring 2012.
Follow-up data were collected at 6, 12, 18 months following baseline data collection.
Study Type
Interventional
Enrollment (Actual)
3531
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72204
- Schools in Arkansas
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Iowa
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Osceola, Iowa, United States, 50213
- Schools in Iowa
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New York
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Ithaca, New York, United States, 14850
- Schools in New York State
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Washington
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Tacoma, Washington, United States, 98418
- Schools in Washington State
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
- Schools did not already have a school garden.
Exclusion Criteria:
none.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: garden intervention
Schools assigned to the garden intervention receive raised bed garden kits and access to a toolkit of garden-based curriculum
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The intervention includes raised bed garden kits for participating classes as well as access to garden-based curriculum.
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No Intervention: Control
Wait-list control (no garden intervention + lessons) until end of the study.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in fruit + vegetable intake at school
Time Frame: change from baseline to follow-up at 6, 12, 18 months
|
Children's lunch trays are photographed before and after lunch for 3 days at each wave of data collection.
Digital Food Image Analysis software computes grams of fruit and grams of vegetables consumed for each pair of lunch tray photos.
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change from baseline to follow-up at 6, 12, 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Garden Intervention Fidelity
Time Frame: At 3 garden intervention time points -- 6, 12, 18 months after baseline
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fruit + vegetables planted, harvested; methods of fruit and vegetable distribution; and garden-based lessons delivered to the class are measures at each wave of data collection from Fall 2011 to Spring 2013.
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At 3 garden intervention time points -- 6, 12, 18 months after baseline
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change fruit & vegetable consumption at home
Time Frame: change from baseline (Fall 2011) to follow-up at 6 months, 12 months, 18 months.
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change from baseline (Fall 2011) to follow-up at 6 months, 12 months, 18 months.
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change in Nutritional Knowledge
Time Frame: change from baseline to follow-up at 6, 12, 18 months
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In the classroom, children complete a 7-item multiple choice questionnaire developed by the Healthy Gardens, Healthy Youth curriculum development team.
The questionnaire includes items about plant science (e.g., Which part of the plant uses the sun's energy to make food?
root, stem, leaf, flower) and nutrition (e.g., Which nutrient supplies our bodies with energy?
fiber, carbohydrates, water, vitamins).
Data represent the number of correct answers.
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change from baseline to follow-up at 6, 12, 18 months
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change in Science Technology Engineering Math (STEM) self efficacy
Time Frame: change from baseline (Fall 2011) to follow-up at 6, 12, 18 months.
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In the classroom, children complete a 15-item questionnaire, derived from the Science Process Skills Inventory (SPSI) (Arnold & Bourdeau, 2009) and the Iowa 4-H Science Youth Self-Assessment (Staker, 2011).
Items include, for example: "I can do an experiment to answer a question" and "I can develop a plan for a good garden I want to plant" with response options "Disagree."
"Not Sure." or "Agree" denoted 1, 2, or 3 respectively.
The STEM self-efficacy score range is thus 15-45, with higher scores indicating that participant has stronger positive beliefs in their abilities to use STEM to solve problems.
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change from baseline (Fall 2011) to follow-up at 6, 12, 18 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nancy M Wells, PhD, Cornell University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
May 15, 2014
First Submitted That Met QC Criteria
June 15, 2014
First Posted (Estimate)
June 18, 2014
Study Record Updates
Last Update Posted (Estimate)
June 18, 2014
Last Update Submitted That Met QC Criteria
June 15, 2014
Last Verified
May 1, 2014
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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