- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT04864574
Childcare Outdoor Learning Environments as Active Food Systems (COLEAFS)
Childcare Outdoor Learning Environments as Active Food Systems: Effectiveness of the Preventing Obesity by Design (POD) Gardening Component
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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North Carolina
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Cary, North Carolina, Stany Zjednoczone, 27511
- White Plains Children's Center
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Cary, North Carolina, Stany Zjednoczone, 27513
- The Goddard School
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Fuquay-Varina, North Carolina, Stany Zjednoczone, 27526
- Kiddie Academy of Fuquay
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Fuquay-Varina, North Carolina, Stany Zjednoczone, 27526
- Ready or Not, Here I Grow
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Knightdale, North Carolina, Stany Zjednoczone, 27545
- Kids Educational Center
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Knightdale, North Carolina, Stany Zjednoczone, 27545
- Touched by an Angel Open Arms
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Raleigh, North Carolina, Stany Zjednoczone, 276013
- La Petite Academy - Leesville
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Raleigh, North Carolina, Stany Zjednoczone, 27604
- KinderCare Learning Center
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Raleigh, North Carolina, Stany Zjednoczone, 27604
- La Petite Academy - Hedingham
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Raleigh, North Carolina, Stany Zjednoczone, 27609
- Raleigh Rainbow Child Care Center
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Raleigh, North Carolina, Stany Zjednoczone, 27610
- Appletree Child Development Center, Inc. #3
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Raleigh, North Carolina, Stany Zjednoczone, 27610
- Kids First Academy
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Raleigh, North Carolina, Stany Zjednoczone, 27610
- Kreepers N Krawlers Child Care Center
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Raleigh, North Carolina, Stany Zjednoczone, 27620
- Appletree Child Development Center, Inc. #4
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Wake Forest, North Carolina, Stany Zjednoczone, 27587
- The Learning Experience
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Group 1 - Intervention
Participating children have daily access to the fruit and vegetable garden beginning Year 1.
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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. |
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Eksperymentalny: Group 2 - Wait-list control (delayed intervention)
Participating children have daily access to the fruit and vegetable garden beginning Year 2.
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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. |
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Brak interwencji: Group 3 - Control
No intervention
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Ramy czasowe: Change from baseline to 5 months
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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
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Change in mean vegetable knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Ramy czasowe: Change from baseline to 5 months
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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
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Change in mean fruit liking 6-item, measured by 5-point scale pictorial questionnaire after 5 months of gardening.
Ramy czasowe: Change from baseline to 5 months
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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
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Change in mean vegetable liking 6-item, measured by 5-point face scale pictorial questionnaire after 5 months of gardening.
Ramy czasowe: 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 from baseline to 5 months
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Change in fruit consumption, measured by mean weight of 6 snack-time fruit consumed after 5 months of gardening
Ramy czasowe: Change from baseline to 5 months
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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
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Change in vegetable consumption, measured by mean weight of six snack-time vegetables consumed after 5 months of gardening
Ramy czasowe: 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 from baseline to 5 months
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Change in physical activity level (percent of day at sedentary, moderate, and vigorous levels), measured by Actigraph GT3x+ after 5 months of gardening activities.
Ramy czasowe: Change from baseline to 5 months
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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
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Nilda G Cosco, PhD, NC State University, College of Design
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2017-68001-26354 NIFA
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Garden installation
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