Clinical trial NCT04864574: Childcare Outdoor Learning Environments as Active Food Systems
Official title: Childcare Outdoor Learning Environments as Active Food Systems: Effectiveness of the Preventing Obesity by Design (POD) Gardening Component
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Sedentary Behavior
Keywords: Childhood obesity
Gardening
Fruit consumption
Vegetable consumption
Lead sponsor: North Carolina State University
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 286
Sex: ALL
Minimum age (years): 42
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
timeFrame: Change from baseline to 5 months
measure: Change in mean vegetable knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
timeFrame: Change from baseline to 5 months
measure: Change in mean fruit liking 6-item, measured by 5-point scale pictorial questionnaire after 5 months of gardening.
timeFrame: Change from baseline to 5 months
measure: Change in mean vegetable liking 6-item, measured by 5-point face scale pictorial questionnaire after 5 months of gardening.
timeFrame: Change from baseline to 5 months
measure: Change in fruit consumption, measured by mean weight of 6 snack-time fruit consumed after 5 months of gardening
timeFrame: Change from baseline to 5 months
measure: Change in vegetable consumption, measured by mean weight of six snack-time vegetables consumed after 5 months of gardening
timeFrame: Change from baseline to 5 months
measure: Change in physical activity level (percent of day at sedentary, moderate, and vigorous levels), measured by Actigraph GT3x+ after 5 months of gardening activities.
timeFrame: Change from baseline to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cary
country: United States
facility: White Plains Children's Center
state: North Carolina
city: Cary
country: United States
facility: The Goddard School
state: North Carolina
city: Fuquay-Varina
country: United States
facility: Kiddie Academy of Fuquay
state: North Carolina
city: Fuquay-Varina
country: United States
facility: Ready or Not, Here I Grow
state: North Carolina
city: Knightdale
country: United States
facility: Kids Educational Center
state: North Carolina
city: Knightdale
country: United States
facility: Touched by an Angel Open Arms
state: North Carolina
city: Raleigh
country: United States
facility: La Petite Academy - Leesville
state: North Carolina
city: Raleigh
country: United States
facility: KinderCare Learning Center
state: North Carolina
city: Raleigh
country: United States
facility: La Petite Academy - Hedingham
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Rainbow Child Care Center
state: North Carolina
city: Raleigh
country: United States
facility: Appletree Child Development Center, Inc. #3
state: North Carolina
city: Raleigh
country: United States
facility: Kids First Academy
state: North Carolina
city: Raleigh
country: United States
facility: Kreepers N Krawlers Child Care Center
state: North Carolina
city: Raleigh
country: United States
facility: Appletree Child Development Center, Inc. #4
state: North Carolina
city: Wake Forest
country: United States
facility: The Learning Experience
state: North Carolina
Study officials:
affiliation: NC State University, College of Design
name: Nilda G Cosco, PhD
role: PRINCIPAL_INVESTIGATOR
References: