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Childcare Outdoor Learning Environments as Active Food Systems (COLEAFS)

26 de abril de 2021 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Real)

286

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

3 anos a 6 anos (Filho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.

Experimental: 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.

Sem intervenção: Group 3 - Control
No intervention

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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
Prazo: 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
Prazo: 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.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Nilda G Cosco, PhD, NC State University, College of Design

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de junho de 2017

Conclusão Primária (Real)

5 de setembro de 2019

Conclusão do estudo (Real)

1 de outubro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

10 de abril de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de abril de 2021

Primeira postagem (Real)

29 de abril de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

29 de abril de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de abril de 2021

Última verificação

1 de abril de 2021

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 2017-68001-26354 NIFA

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

Six months after publication

Critérios de acesso de compartilhamento 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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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