Childcare Outdoor Learning Environments as Active Food Systems

Pediatric Obesity Clinical Trial

— COLEAFS  

Official title:

Childcare Outdoor Learning Environments as Active Food Systems: Effectiveness of the Preventing Obesity by Design (POD) Gardening Component

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864574
• Other study ID #: 2017-68001-26354 NIFA
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: April 2021
• Source: North Carolina State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: October 1, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 42 Months to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity
• Sedentary Behavior

Intervention

Other:
• Garden installation
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.

Locations

Country	Name	City	State
United States	The Goddard School	Cary	North Carolina
United States	White Plains Children's Center	Cary	North Carolina
United States	Kiddie Academy of Fuquay	Fuquay-Varina	North Carolina
United States	Ready or Not, Here I Grow	Fuquay-Varina	North Carolina
United States	Kids Educational Center	Knightdale	North Carolina
United States	Touched by an Angel Open Arms	Knightdale	North Carolina
United States	Appletree Child Development Center, Inc. #3	Raleigh	North Carolina
United States	Appletree Child Development Center, Inc. #4	Raleigh	North Carolina
United States	Kids First Academy	Raleigh	North Carolina
United States	KinderCare Learning Center	Raleigh	North Carolina
United States	Kreepers N Krawlers Child Care Center	Raleigh	North Carolina
United States	La Petite Academy - Hedingham	Raleigh	North Carolina
United States	La Petite Academy - Leesville	Raleigh	North Carolina
United States	Raleigh Rainbow Child Care Center	Raleigh	North Carolina
United States	The Learning Experience	Wake Forest	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
North Carolina State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from baseline to 5 months
Primary	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 from baseline to 5 months
Primary	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 from baseline to 5 months
Primary	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 from baseline to 5 months
Primary	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 from baseline to 5 months
Primary	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 from baseline to 5 months
Primary	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	Change from baseline to 5 months