Dietary HabitsHGHYNCT02166034
Effects of School Gardens on Children's Diet, Nutritional Knowledge, Etc.
A study testing garden intervention in people with Dietary Habits, run by Cornell University at 4 sites in United States.
Trial summary
The purpose of this study is to determine whether school gardens influence children's dietary intake, nutritional knowledge, and other outcomes. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Dietary Habits
- What is being tested?
- garden intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,531 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2011to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
- Schools did not already have a school garden.
Who cannot join
- none.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Schools in New York State
Ithaca, New York, 14850
Schools in Arkansas
Little Rock, Arkansas, 72204
Schools in Iowa
Osceola, Iowa, 50213
Schools in Washington State
Tacoma, Washington, 98418
About this study
Official title: 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.
Read the 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.
- Conditions
- Dietary Habits
- Being tested
- garden intervention
- Keywords
- children, fruit, vegetable, diet, school, garden
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
garden interventionBehavioural
The intervention includes raised bed garden kits for participating classes as well as access to garden-based curriculum.
| Study group | Role | What they receive |
|---|---|---|
| garden intervention | Experimental | Schools assigned to the garden intervention receive raised bed garden kits and access to a toolkit of garden-based curriculum Receives: Behavioral: garden intervention |
| Control | No intervention | Wait-list control (no garden intervention + lessons) until end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in fruit + vegetable intake at school
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.
Measured: change from baseline to follow-up at 6, 12, 18 months
Secondary outcomes (4)
Garden Intervention Fidelity
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.
Measured: At 3 garden intervention time points -- 6, 12, 18 months after baseline
change fruit & vegetable consumption at home
Measured: change from baseline (Fall 2011) to follow-up at 6 months, 12 months, 18 months.
change in Nutritional Knowledge
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.
Measured: change from baseline to follow-up at 6, 12, 18 months
change in Science Technology Engineering Math (STEM) self efficacy
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.
Measured: change from baseline (Fall 2011) to follow-up at 6, 12, 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startAug 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dietary HabitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Washington State University, University of Arkansas, Iowa State University
- Responsible party
- Sponsor
- Investigators
- Nancy M Wells, PhD, Study director, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166034
- Sponsor's protocol ID
- CN-CGP-11-0047
- Acronym
- HGHY
- Status last verified
- May 2014
- First submitted
- 15 May 2014
- Last updated
- 18 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wells NM, Meyers BM, Todd LE, Henderson CR Jr, Barale K, Gaolach B, Ferenz G, Aitken M, Tse CC, Pattison KO, Hendrix L, Carson JB, Taylor C, Franz NK. The carry-over effects of school gardens on fruit and vegetable availability at home: A randomized controlled trial with low-income elementary schools. Prev Med. 2018 Jul;112:152-159. doi: 10.1016/j.ypmed.2018.03.022. Epub 2018 Apr 5.
PubMed 29627512
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Gardens, Healthy Youth (HGHY): A People's Garden School Pilot Program
- ClinicalTrials.gov ID
- NCT02166034
- Acronym / sponsor ID
- HGHY / CN-CGP-11-0047
- Conditions
- Dietary Habits
- Keywords
- children, fruit, vegetable, diet, school, garden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,531 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- Washington State University, University of Arkansas, Iowa State University
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether school gardens influence children's dietary intake, nutritional knowledge, and other outcomes.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| garden intervention | Experimental | Behavioral: garden interventionSchools assigned to the garden intervention receive raised bed garden kits and access to a toolkit of garden-based curriculum |
| Control | No intervention | –Wait-list control (no garden intervention + lessons) until end of the study. |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Schools had at least 50% of enrolled children qualifying for free + reduced price meals (FRPM)
- Schools did not already have a school garden.
Key exclusion criteria (1 listed)
- none.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| garden interventionThe intervention includes raised bed garden kits for participating classes as well as access to garden-based curriculum. | Behavioural | garden intervention |
Primary outcome
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.
4 secondary outcomes
Garden Intervention Fidelity
Time frame: At 3 garden intervention time points -- 6, 12, 18 months after baseline
change fruit & vegetable consumption at home
Time frame: change from baseline (Fall 2011) to follow-up at 6 months, 12 months, 18 months.
change in Nutritional Knowledge
Time frame: change from baseline to follow-up at 6, 12, 18 months
change in Science Technology Engineering Math (STEM) self efficacy
Time frame: change from baseline (Fall 2011) to follow-up at 6, 12, 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2014.
- Derived from this study: PubMed 29627512Wells NM, Meyers BM, Todd LE, Henderson CR Jr, Barale K, Gaolach B, Ferenz G, Aitken M, Tse CC, Pattison KO, Hendrix L, Carson JB, Taylor C, Franz NK. The carry-over effects of school gardens on fruit and vegetable availability at home: A randomized controlled trial with low-income elementary schools. Prev Med. 2018 Jul;112:152-159. doi: 10.1016/j.ypmed.2018.03.022. Epub 2018 Apr 5.
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Dietary Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy M Wells, PhD study director
Cornell University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing garden intervention in people with Dietary Habits, run by Cornell University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in fruit + vegetable intake at school (time frame: change from baseline to follow-up at 6, 12, 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02166034, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2014.