Childcare Outdoor Learning Environments as Active Food Systems (COLEAFS)
Primary Purpose
Pediatric Obesity, Sedentary Behavior
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Garden installation
Sponsored by
About this trial
This is an interventional prevention trial for Pediatric Obesity focused on measuring Childhood obesity, Gardening, Fruit consumption, Vegetable consumption
Eligibility Criteria
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
Sites / Locations
- White Plains Children's Center
- The Goddard School
- Kiddie Academy of Fuquay
- Ready or Not, Here I Grow
- Kids Educational Center
- Touched by an Angel Open Arms
- La Petite Academy - Leesville
- KinderCare Learning Center
- La Petite Academy - Hedingham
- Raleigh Rainbow Child Care Center
- Appletree Child Development Center, Inc. #3
- Kids First Academy
- Kreepers N Krawlers Child Care Center
- Appletree Child Development Center, Inc. #4
- The Learning Experience
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Group 1 - Intervention
Group 2 - Wait-list control (delayed intervention)
Group 3 - Control
Arm Description
Participating children have daily access to the fruit and vegetable garden beginning Year 1.
Participating children have daily access to the fruit and vegetable garden beginning Year 2.
No intervention
Outcomes
Primary Outcome Measures
Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
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 in mean vegetable knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
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 in mean fruit liking 6-item, measured by 5-point scale pictorial questionnaire after 5 months of gardening.
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 in mean vegetable liking 6-item, measured by 5-point face scale pictorial questionnaire after 5 months of gardening.
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 in fruit consumption, measured by mean weight of 6 snack-time fruit consumed after 5 months of gardening
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 in vegetable consumption, measured by mean weight of six snack-time vegetables consumed after 5 months of gardening
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 in physical activity level (percent of day at sedentary, moderate, and vigorous levels), measured by Actigraph GT3x+ after 5 months of gardening activities.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04864574
First Posted
April 10, 2021
Last Updated
April 26, 2021
Sponsor
North Carolina State University
1. Study Identification
Unique Protocol Identification Number
NCT04864574
Brief Title
Childcare Outdoor Learning Environments as Active Food Systems
Acronym
COLEAFS
Official Title
Childcare Outdoor Learning Environments as Active Food Systems: Effectiveness of the Preventing Obesity by Design (POD) Gardening Component
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Carolina State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this project is to assess the effectiveness of the fruit and vegetable (FV) gardening component of the Preventing Obesity by Design strategy to support preschool fresh fruit and vegetable knowledge, liking and consumption, and physical activity in children 3-5 years old living in under-resourced communities and attending childcare using a Randomized Controlled Trial research design. Sample: 15 childcare centers, 286 children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity, Sedentary Behavior
Keywords
Childhood obesity, Gardening, Fruit consumption, Vegetable consumption
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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 2. Group 1, initial intervention centers, received the garden intervention in the summer of Year 1 and both groups were assessed in the Fall, post intervention. No further data was collected from Group 1.
In Year 2, Groups 2 and 3 were assessed in the Spring. Group 2, the wait-list control centers, received the garden intervention in the summer of Year 2, and both Groups 2 and 3 were assessed in the Fall of Year 2.
No further data was collected.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - Intervention
Arm Type
Experimental
Arm Description
Participating children have daily access to the fruit and vegetable garden beginning Year 1.
Arm Title
Group 2 - Wait-list control (delayed intervention)
Arm Type
Experimental
Arm Description
Participating children have daily access to the fruit and vegetable garden beginning Year 2.
Arm Title
Group 3 - Control
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Garden installation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Description
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
Time Frame
Change from baseline to 5 months
Title
Change in mean vegetable knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Description
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.
Time Frame
Change from baseline to 5 months
Title
Change in mean fruit liking 6-item, measured by 5-point scale pictorial questionnaire after 5 months of gardening.
Description
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.
Time Frame
Change from baseline to 5 months
Title
Change in mean vegetable liking 6-item, measured by 5-point face scale pictorial questionnaire after 5 months of gardening.
Description
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.
Time Frame
Change from baseline to 5 months
Title
Change in fruit consumption, measured by mean weight of 6 snack-time fruit consumed after 5 months of gardening
Description
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.
Time Frame
Change from baseline to 5 months
Title
Change in vegetable consumption, measured by mean weight of six snack-time vegetables consumed after 5 months of gardening
Description
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.
Time Frame
Change from baseline to 5 months
Title
Change in physical activity level (percent of day at sedentary, moderate, and vigorous levels), measured by Actigraph GT3x+ after 5 months of gardening activities.
Description
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
Time Frame
Change from baseline to 5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
42 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilda G Cosco, PhD
Organizational Affiliation
NC State University, College of Design
Official's Role
Principal Investigator
Facility Information:
Facility Name
White Plains Children's Center
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
The Goddard School
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Facility Name
Kiddie Academy of Fuquay
City
Fuquay-Varina
State/Province
North Carolina
ZIP/Postal Code
27526
Country
United States
Facility Name
Ready or Not, Here I Grow
City
Fuquay-Varina
State/Province
North Carolina
ZIP/Postal Code
27526
Country
United States
Facility Name
Kids Educational Center
City
Knightdale
State/Province
North Carolina
ZIP/Postal Code
27545
Country
United States
Facility Name
Touched by an Angel Open Arms
City
Knightdale
State/Province
North Carolina
ZIP/Postal Code
27545
Country
United States
Facility Name
La Petite Academy - Leesville
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
276013
Country
United States
Facility Name
KinderCare Learning Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27604
Country
United States
Facility Name
La Petite Academy - Hedingham
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27604
Country
United States
Facility Name
Raleigh Rainbow Child Care Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Appletree Child Development Center, Inc. #3
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Kids First Academy
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Kreepers N Krawlers Child Care Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Appletree Child Development Center, Inc. #4
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27620
Country
United States
Facility Name
The Learning Experience
City
Wake Forest
State/Province
North Carolina
ZIP/Postal Code
27587
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The Study Protocol and Statistical Analysis Plan (SAP) will shared at the the end of the study after results and conclusion have been published.
IPD Sharing Time Frame
Six months after publication
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.
Learn more about this trial
Childcare Outdoor Learning Environments as Active Food Systems
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