- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864574
Childcare Outdoor Learning Environments as Active Food Systems (COLEAFS)
Childcare Outdoor Learning Environments as Active Food Systems: Effectiveness of the Preventing Obesity by Design (POD) Gardening Component
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Objective: To assess the effectiveness of a gardening component on preschool children's knowledge, liking and consumption of fruit and vegetable consumption, and their level of physical activity during gardening season.
Intervention: Fruit and vegetable garden installation. Childcare centers were randomly assigned to one of three groups: Group 1, intervention (5 centers); Group 2, wait list control (5 centers); Group 3, no-intervention control (5 centers).
In Year 1 (Spring), baseline data was collected from Groups 1 and Group 2 (waitlist). Group 1, initial intervention centers, received the garden intervention in the Summer and both groups were assessed in the Fall, post intervention. No further data was collected from Group 1.
In Year 2 (Spring), Group 2 (waitlist, now intervention) and Group 3 were assessed. Group 2, received the garden intervention in the Summer of Year 2 and both groups were assessed in the Fall of Year 2.
No further data was collected.
Sample: 15 centers. Children: 286 (4 and 5 years old). Center demographic profile includes child data: age, gender, parental education, race/ethnicity, special needs, and height/weight (BMI). To avoid losing "graduating" five year old children, post-intervention data was gathered before school start date.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Cary, North Carolina, United States, 27511
- White Plains Children's Center
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Cary, North Carolina, United States, 27513
- The Goddard School
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Fuquay-Varina, North Carolina, United States, 27526
- Kiddie Academy of Fuquay
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Fuquay-Varina, North Carolina, United States, 27526
- Ready or Not, Here I Grow
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Knightdale, North Carolina, United States, 27545
- Kids Educational Center
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Knightdale, North Carolina, United States, 27545
- Touched by an Angel Open Arms
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Raleigh, North Carolina, United States, 276013
- La Petite Academy - Leesville
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Raleigh, North Carolina, United States, 27604
- KinderCare Learning Center
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Raleigh, North Carolina, United States, 27604
- La Petite Academy - Hedingham
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Raleigh, North Carolina, United States, 27609
- Raleigh Rainbow Child Care Center
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Raleigh, North Carolina, United States, 27610
- Appletree Child Development Center, Inc. #3
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Raleigh, North Carolina, United States, 27610
- Kids First Academy
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Raleigh, North Carolina, United States, 27610
- Kreepers N Krawlers Child Care Center
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Raleigh, North Carolina, United States, 27620
- Appletree Child Development Center, Inc. #4
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Wake Forest, North Carolina, United States, 27587
- The Learning Experience
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Children enrolled in selected childcare centers
- Parental consent
- Child consent to participate at the time of data collection
Exclusion Criteria:
- No parental consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1 - Intervention
Participating children have daily access to the fruit and vegetable garden beginning Year 1.
|
Garden installation: 6 raised planting beds (4x6x16") configured in a single line with direct sun at least 6 hrs./day, close to hose bib, sufficient distances to allow working from most sides, vegetable vines spill over space, and storage unit for tools. Planting beds constructed from a standard kit. Beds filled with high quality growing medium. Plants selection criteria: a) documented harvest success in NC Piedmont; b) able to be eaten raw, c) harvest times at the same time (except strawberries). Designated beds and plants: Bed 1: 4 pepper, 2 tomato; Bed 2: 20 bean on 2 mini-teepees, 2 cucumber (trellised); Bed 3: 1 yellow squash, 1 zucchini; Bed 4: 2 blueberry bushes, 12 strawberry; Bed 5: 2 cantaloupe. Bed 6: 2 watermelon. 2 Blackberries planted at ground level on trellis. |
Experimental: Group 2 - Wait-list control (delayed intervention)
Participating children have daily access to the fruit and vegetable garden beginning Year 2.
|
Garden installation: 6 raised planting beds (4x6x16") configured in a single line with direct sun at least 6 hrs./day, close to hose bib, sufficient distances to allow working from most sides, vegetable vines spill over space, and storage unit for tools. Planting beds constructed from a standard kit. Beds filled with high quality growing medium. Plants selection criteria: a) documented harvest success in NC Piedmont; b) able to be eaten raw, c) harvest times at the same time (except strawberries). Designated beds and plants: Bed 1: 4 pepper, 2 tomato; Bed 2: 20 bean on 2 mini-teepees, 2 cucumber (trellised); Bed 3: 1 yellow squash, 1 zucchini; Bed 4: 2 blueberry bushes, 12 strawberry; Bed 5: 2 cantaloupe. Bed 6: 2 watermelon. 2 Blackberries planted at ground level on trellis. |
No Intervention: Group 3 - Control
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Time Frame: Change from baseline to 5 months
|
Measured by presenting child with an image of each of 6 fruit on a tablet screen and asking the child if he/she knows (Y/N) the fruit. Pictorial questionnaire based on Carraway-Stage, V., Spangler, H., Borges, M., & Goodell, L. S. (2014). Evaluation of a pictorial method to assess liking of familiar fruits and vegetables among preschool children. Appetite, 75, 11-20. Six fruits: apple, blueberries, blackberry, strawberry, cantaloupe, watermelon. Same fruits were planted in the garden except for apple that takes too long to produce fruit |
Change from baseline to 5 months
|
Change in mean vegetable knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Time Frame: Change from baseline to 5 months
|
Measured by presenting child with an image of each of 6 vegetables on a tablet screen and asking the child if he/she knows (Y/N) the vegetable. Pictorial questionnaire based on Carraway-Stage, V., Spangler, H., Borges, M., & Goodell, L. S. (2014). Evaluation of a pictorial method to assess liking of familiar fruits and vegetables among preschool children. Appetite, 75, 11-20. Six vegetables: cucumber, green bean, red pepper, yellow squash, tomato, and zucchini. Same vegetables were planted in the garden. |
Change from baseline to 5 months
|
Change in mean fruit liking 6-item, measured by 5-point scale pictorial questionnaire after 5 months of gardening.
Time Frame: Change from baseline to 5 months
|
Measured by presenting child with an image of each of the 6 fruit (one by one) on a tablet screen and asking she/he to indicate whether the fruit is super yummy, yummy, just okay, yucky, super yucky by pointing at one of 5 non-gendered faces representing a 5-point scale of liking. This age-appropriate measure is based upon Carraway-Stage, V., Spangler, H., Borges, M., & Goodell, L. S. (2014). Evaluation of a pictorial method to assess liking of familiar fruits and vegetables among preschool children. Appetite, 75, 11-20. Six fruits: apple, blueberries, blackberry, strawberry, cantaloupe, watermelon. Same fruits were planted in the garden except for apple that takes too long to produce fruit. |
Change from baseline to 5 months
|
Change in mean vegetable liking 6-item, measured by 5-point face scale pictorial questionnaire after 5 months of gardening.
Time Frame: Change from baseline to 5 months
|
Measured by presenting child with an image of each of the 6 vegetables (one by one) on a tablet screen and asking she/he to indicate whether the vegetable is super yummy, yummy, just okay, yucky, super yucky by pointing at a one of 5 non-gendered faces representing a 5-point scale of liking. This age-appropriate measure is based upon Carraway-Stage, V., Spangler, H., Borges, M., & Goodell, L. S. (2014). Evaluation of a pictorial method to assess liking of familiar fruits and vegetables among preschool children. Appetite, 75, 11-20. Six vegetables: cucumber, green bean, red pepper, yellow squash, tomato, and zucchini. Same vegetables were planted in the garden. |
Change from baseline to 5 months
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Change in fruit consumption, measured by mean weight of 6 snack-time fruit consumed after 5 months of gardening
Time Frame: Change from baseline to 5 months
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Objective measurement of grams of fruit consumed during snack time data collection. Store-bought, standard pieces of fruits offered on individual segmented trays (6" x 12"). Each tray is labeled with a child's ID number. Six fruits (approximately 50gr/each are served). The measure is based on the Fruit & Vegetable Snack Tool, Witt KE, Dunn C. Increasing Fruit and Vegetable Consumption among Preschoolers: Evaluation of Color Me Healthy. J Nutr Educ Behav. 2012;44(2):107-113. Fruit servings are weighed in grams before and after the snack consumption session to the nearest .01gr. Fruits offered for consumption are the same as shown on pictorial tablet questionnaires (knowledge and liking) and planted in the intervention gardens except for apple that takes too long to produce fruit. Six fruits: apple, blueberries, blackberry, strawberry, cantaloupe, watermelon. |
Change from baseline to 5 months
|
Change in vegetable consumption, measured by mean weight of six snack-time vegetables consumed after 5 months of gardening
Time Frame: Change from baseline to 5 months
|
Objective measurement of grams of vegetable consumed during snack time data collection. Store-bought, standard pieces of vegetables offered on individual segmented trays (6" x 12"). Each tray is labeled with a child's ID number. Six vegetables (approximately 50gr/each) are served. The measure is based on the Fruit & Vegetable Snack Tool, Witt KE, Dunn C. Increasing Fruit and Vegetable Consumption among Preschoolers: Evaluation of Color Me Healthy. J Nutr Educ Behav. 2012;44(2):107-113. Vegetable servings are weighed in grams before and after the snack consumption session to the nearest .01gr. Vegetables offered for consumption are the same shown on pictorial tablet questionnaires (knowledge and liking) and planted in the intervention gardens. Six vegetables: cucumber, green bean, red pepper, yellow squash, tomato, and zucchini. |
Change from baseline to 5 months
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Change in physical activity level (percent of day at sedentary, moderate, and vigorous levels), measured by Actigraph GT3x+ after 5 months of gardening activities.
Time Frame: Change from baseline to 5 months
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Children wear Actigraph GT3x+ accelerometers for three consecutive days during same weeks of Outcome 1 - 6 data collection in April (before garden installation) and August (end of garden season) each study year. Minutes of sedentary (< 8.3 counts/5 sec), light (8.4-191 counts/5 sec), moderate (192-334 counts/5 sec), and vigorous (≥335 counts/5 sec) physical activity is computed based on METS. The measure is based on Evenson KR, Catellier DJ, Gill K, Ondrak KS, McMurray RG. Calibration of two objective measures of physical activity for children. J Sports Sci. 2008;26(14):1557-1565. doi:10.1080/02640410802334196 |
Change from baseline to 5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nilda G Cosco, PhD, NC State University, College of Design
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-68001-26354 NIFA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Selected data will be shared via corresponding authors of scientific articles.
Corresponding authors will review requests and release Study Protocols and Statistical Plan as appropriate.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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