NCT04864574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

2.3 years

First QC Date

April 10, 2021

Last Update Submit

April 26, 2021

Conditions

Keywords

Childhood obesityGardeningFruit consumptionVegetable consumption

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Group 1 - Intervention

EXPERIMENTAL

Participating children have daily access to the fruit and vegetable garden beginning Year 1.

Other: Garden installation

Group 2 - Wait-list control (delayed intervention)

EXPERIMENTAL

Participating children have daily access to the fruit and vegetable garden beginning Year 2.

Other: Garden installation

Group 3 - Control

NO INTERVENTION

No intervention

Interventions

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.

Group 1 - InterventionGroup 2 - Wait-list control (delayed intervention)

Eligibility Criteria

Age42 Months - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children enrolled in selected childcare centers
  • Parental consent
  • Child consent to participate at the time of data collection

You may not qualify if:

  • No parental consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

White Plains Children's Center

Cary, North Carolina, 27511, United States

Location

The Goddard School

Cary, North Carolina, 27513, United States

Location

Kiddie Academy of Fuquay

Fuquay-Varina, North Carolina, 27526, United States

Location

Ready or Not, Here I Grow

Fuquay-Varina, North Carolina, 27526, United States

Location

Kids Educational Center

Knightdale, North Carolina, 27545, United States

Location

Touched by an Angel Open Arms

Knightdale, North Carolina, 27545, United States

Location

La Petite Academy - Leesville

Raleigh, North Carolina, 276013, United States

Location

KinderCare Learning Center

Raleigh, North Carolina, 27604, United States

Location

La Petite Academy - Hedingham

Raleigh, North Carolina, 27604, United States

Location

Raleigh Rainbow Child Care Center

Raleigh, North Carolina, 27609, United States

Location

Appletree Child Development Center, Inc. #3

Raleigh, North Carolina, 27610, United States

Location

Kids First Academy

Raleigh, North Carolina, 27610, United States

Location

Kreepers N Krawlers Child Care Center

Raleigh, North Carolina, 27610, United States

Location

Appletree Child Development Center, Inc. #4

Raleigh, North Carolina, 27620, United States

Location

The Learning Experience

Wake Forest, North Carolina, 27587, United States

Location

Related Publications (1)

  • Cosco NG, Wells NM, Zhang D, Goodell LS, Monsur M, Xu T, Moore RC. Hands-on childcare garden intervention: A randomized controlled trial to assess effects on fruit and vegetable identification, liking, and consumption among children aged 3-5 years in North Carolina. Front Psychol. 2022 Nov 10;13:993637. doi: 10.3389/fpsyg.2022.993637. eCollection 2022.

MeSH Terms

Conditions

Pediatric ObesitySedentary Behavior

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Nilda G Cosco, PhD

    NC State University, College of Design

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 10, 2021

First Posted

April 29, 2021

Study Start

June 1, 2017

Primary Completion

September 5, 2019

Study Completion

October 1, 2019

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

The Study Protocol and Statistical Analysis Plan (SAP) will shared at the the end of the study after results and conclusion have been published.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Six months after publication
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.

Locations