Pediatric ObesityCOLEAFSNCT04864574
Childcare Outdoor Learning Environments as Active Food Systems
A study testing Garden installation in people with Pediatric Obesity and Sedentary Behavior, run by North Carolina State University at 15 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 42 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Sedentary Behavior
- What is being tested?
- Garden installation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 15 sitesUnited States
- Study dates
- 1 Jun 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children enrolled in selected childcare centers
- Parental consent
- Child consent to participate at the time of data collection
Who cannot join
- No parental consent
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
White Plains Children's Center
Cary, North Carolina, 27511
The Goddard School
Cary, North Carolina, 27513
Kiddie Academy of Fuquay
Fuquay-Varina, North Carolina, 27526
Ready or Not, Here I Grow
Fuquay-Varina, North Carolina, 27526
Kids Educational Center
Knightdale, North Carolina, 27545
Touched by an Angel Open Arms
Knightdale, North Carolina, 27545
La Petite Academy - Leesville
Raleigh, North Carolina, 276013
KinderCare Learning Center
Raleigh, North Carolina, 27604
La Petite Academy - Hedingham
Raleigh, North Carolina, 27604
Raleigh Rainbow Child Care Center
Raleigh, North Carolina, 27609
Appletree Child Development Center, Inc. #3
Raleigh, North Carolina, 27610
Kids First Academy
Raleigh, North Carolina, 27610
Kreepers N Krawlers Child Care Center
Raleigh, North Carolina, 27610
Appletree Child Development Center, Inc. #4
Raleigh, North Carolina, 27620
The Learning Experience
Wake Forest, North Carolina, 27587
About this study
Official title: Childcare Outdoor Learning Environments as Active Food Systems: Effectiveness of the Preventing Obesity by Design (POD) Gardening Component
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.
Read the 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.
- Conditions
- Pediatric Obesity, Sedentary Behavior
- Being tested
- Garden installation
- Keywords
- Childhood obesity, Gardening, Fruit consumption, Vegetable consumption
- Medical subject headings
- Pediatric Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Garden installationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Intervention | Experimental | Participating children have daily access to the fruit and vegetable garden beginning Year 1. Receives: 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. Receives: Other: Garden installation |
| Group 3 - Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Change from baseline to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 Jun 2017
- Primary completion5 Sep 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Carolina State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilda Graciela Cosco, North Carolina State University
- Investigators
- Nilda G Cosco, PhD, Principal investigator, NC State University, College of Design
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864574
- Sponsor's protocol ID
- 2017-68001-26354 NIFA
- Other IDs
- 2017
- Acronym
- COLEAFS
- Status last verified
- Apr 2021
- First submitted
- 10 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Study Protocol and Statistical Analysis Plan (SAP) will shared at the the end of the study after results and conclusion have been published.
Publications
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.
PubMed 36438334
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Childcare Outdoor Learning Environments as Active Food Systems: Effectiveness of the Preventing Obesity by Design (POD) Gardening Component
- ClinicalTrials.gov ID
- NCT04864574
- Acronym / sponsor ID
- COLEAFS / 2017-68001-26354 NIFA
- Conditions
- Pediatric Obesity, Sedentary Behavior
- Keywords
- Childhood obesity, Gardening, Fruit consumption, Vegetable consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- North Carolina State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 5 Sep 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 29 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Intervention | Experimental | Other: Garden installationParticipating children have daily access to the fruit and vegetable garden beginning Year 1. |
| Group 2 - Wait-list control (delayed intervention) | Experimental | Other: Garden installationParticipating children have daily access to the fruit and vegetable garden beginning Year 2. |
| Group 3 - Control | No intervention | –No intervention |
Who may qualify
- Ages
- 42 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children enrolled in selected childcare centers
- Parental consent
- Child consent to participate at the time of data collection
Key exclusion criteria (1 listed)
- No parental consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Garden installationGarden 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. | Other | Group 1 - Intervention, Group 2 - Wait-list control (delayed intervention) |
Primary outcome
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 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 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 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 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
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
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 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 36438334Cosco 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.
- Individual participant dataSharing planned: Yes. The Study Protocol and Statistical Analysis Plan (SAP) will shared at the the end of the study after results and conclusion have been published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilda G Cosco, PhD principal investigator
NC State University, College of Design
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Garden installation in people with Pediatric Obesity and Sedentary Behavior, run by North Carolina State University at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening. (time frame: Change from baseline to 5 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04864574, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.