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Childcare Outdoor Learning Environments as Active Food Systems (COLEAFS)

26 апреля 2021 г. обновлено: Nilda Graciela Cosco, North Carolina State University

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.

Обзор исследования

Статус

Завершенный

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

286

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

    • North Carolina
      • Cary, North Carolina, Соединенные Штаты, 27511
        • White Plains Children's Center
      • Cary, North Carolina, Соединенные Штаты, 27513
        • The Goddard School
      • Fuquay-Varina, North Carolina, Соединенные Штаты, 27526
        • Kiddie Academy of Fuquay
      • Fuquay-Varina, North Carolina, Соединенные Штаты, 27526
        • Ready or Not, Here I Grow
      • Knightdale, North Carolina, Соединенные Штаты, 27545
        • Kids Educational Center
      • Knightdale, North Carolina, Соединенные Штаты, 27545
        • Touched by an Angel Open Arms
      • Raleigh, North Carolina, Соединенные Штаты, 276013
        • La Petite Academy - Leesville
      • Raleigh, North Carolina, Соединенные Штаты, 27604
        • KinderCare Learning Center
      • Raleigh, North Carolina, Соединенные Штаты, 27604
        • La Petite Academy - Hedingham
      • Raleigh, North Carolina, Соединенные Штаты, 27609
        • Raleigh Rainbow Child Care Center
      • Raleigh, North Carolina, Соединенные Штаты, 27610
        • Appletree Child Development Center, Inc. #3
      • Raleigh, North Carolina, Соединенные Штаты, 27610
        • Kids First Academy
      • Raleigh, North Carolina, Соединенные Штаты, 27610
        • Kreepers N Krawlers Child Care Center
      • Raleigh, North Carolina, Соединенные Штаты, 27620
        • Appletree Child Development Center, Inc. #4
      • Wake Forest, North Carolina, Соединенные Штаты, 27587
        • The Learning Experience

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 3 года до 6 лет (Ребенок)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Профилактика
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: Group 1 - Intervention
Participating children have daily access to the fruit and vegetable garden beginning Year 1.

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.

Экспериментальный: Group 2 - Wait-list control (delayed intervention)
Participating children have daily access to the fruit and vegetable garden beginning Year 2.

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.

Без вмешательства: Group 3 - Control
No intervention

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Временное ограничение: 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 from baseline to 5 months
Change in mean vegetable knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Временное ограничение: 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 from baseline to 5 months
Change in mean fruit liking 6-item, measured by 5-point scale pictorial questionnaire after 5 months of gardening.
Временное ограничение: 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 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.
Временное ограничение: 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
Change in fruit consumption, measured by mean weight of 6 snack-time fruit consumed after 5 months of gardening
Временное ограничение: 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 from baseline to 5 months
Change in vegetable consumption, measured by mean weight of six snack-time vegetables consumed after 5 months of gardening
Временное ограничение: 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
Change in physical activity level (percent of day at sedentary, moderate, and vigorous levels), measured by Actigraph GT3x+ after 5 months of gardening activities.
Временное ограничение: 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

Change from baseline to 5 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Главный следователь: Nilda G Cosco, PhD, NC State University, College of Design

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 июня 2017 г.

Первичное завершение (Действительный)

5 сентября 2019 г.

Завершение исследования (Действительный)

1 октября 2019 г.

Даты регистрации исследования

Первый отправленный

10 апреля 2021 г.

Впервые представлено, что соответствует критериям контроля качества

26 апреля 2021 г.

Первый опубликованный (Действительный)

29 апреля 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

29 апреля 2021 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

26 апреля 2021 г.

Последняя проверка

1 апреля 2021 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • 2017-68001-26354 NIFA

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

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

Сроки обмена IPD

Six months after publication

Критерии совместного доступа к 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.

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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