Physical ActivityNCT02148315
School Gardens and Physical Activity
A study testing garden in people with Physical Activity, run by Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether school gardens affect children's physical activity. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Physical Activity
- What is being tested?
- garden
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited 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 8 to 12 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
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether school gardens affect children's physical activity.
Read the detailed description
New York State schools 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
- Physical Activity
- Being tested
- garden
- Keywords
- physical activity, children, school, garden
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gardenBehavioural
| Study group | Role | What they receive |
|---|---|---|
| garden intervention | Experimental | garden kit and access to garden-based lessons Receives: Behavioral: garden |
| no garden | No intervention | control - receives garden and lessons at end of study |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in physical activity
Physical activity was measured using a survey measure, accelerometry, and direct observation.
Measured: change from baseline to follow-ups at 6, 12, 18 months
Secondary outcomes (1)
change in time spent outdoors
Time spent outdoors was measured by lux using accelerometry
Measured: baseline to follow-ups 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 posted28 May 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 (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies 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
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy M Wells, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148315
- Sponsor's protocol ID
- RWFJ 69550
- Status last verified
- May 2014
- First submitted
- 23 May 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wells NM, Myers BM, Henderson CR Jr. Study protocol: effects of school gardens on children's physical activity. Arch Public Health. 2014 Dec 8;72(1):43. doi: 10.1186/2049-3258-72-43. eCollection 2014.
PubMed 25671113Wells NM, Myers BM, Henderson CR Jr. School gardens and physical activity: a randomized controlled trial of low-income elementary schools. Prev Med. 2014 Dec;69 Suppl 1:S27-33. doi: 10.1016/j.ypmed.2014.10.012. Epub 2014 Oct 16.
PubMed 25456803
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Gardens and Physical Activity
- ClinicalTrials.gov ID
- NCT02148315
- Acronym / sponsor ID
- RWFJ 69550
- Conditions
- Physical Activity
- Keywords
- physical activity, children, school, garden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 May 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 affect children's physical activity.
Detailed description
New York State schools 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: gardengarden kit and access to garden-based lessons |
| no garden | No intervention | –control - receives garden and lessons at end of study |
Who may qualify
- Ages
- 8 to 12 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)
- -
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 | Behavioural | garden intervention |
Primary outcome
change in physical activity
Time frame: change from baseline to follow-ups at 6, 12, 18 months
Physical activity was measured using a survey measure, accelerometry, and direct observation.
1 secondary outcome
change in time spent outdoors
Time frame: baseline to follow-ups 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 28 May 2014.
- Derived from this study: PubMed 25671113Wells NM, Myers BM, Henderson CR Jr. Study protocol: effects of school gardens on children's physical activity. Arch Public Health. 2014 Dec 8;72(1):43. doi: 10.1186/2049-3258-72-43. eCollection 2014.
- Derived from this study: PubMed 25456803Wells NM, Myers BM, Henderson CR Jr. School gardens and physical activity: a randomized controlled trial of low-income elementary schools. Prev Med. 2014 Dec;69 Suppl 1:S27-33. doi: 10.1016/j.ypmed.2014.10.012. Epub 2014 Oct 16.
- Wells lab at Cornell UniversityLink provided by the sponsor.
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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 principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing garden in people with Physical Activity, run by Cornell University at 1 site 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 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 physical activity (time frame: change from baseline to follow-ups 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 NCT02148315, which also lists 2 linked publications.
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 28 May 2014.