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Childcare Outdoor Learning Environments as Active Food Systems (COLEAFS)

2021年4月26日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

286

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

3年~6年 (子)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:防止
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.

実験的: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.

介入なし:Group 3 - Control
No intervention

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in mean fruit knowledge 6-item, measured by pictorial questionnaire after 5 months of gardening.
時間枠: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.
時間枠: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.
時間枠: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.
時間枠: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
時間枠: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
時間枠: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.
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Nilda G Cosco, PhD、NC State University, College of Design

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年6月1日

一次修了 (実際)

2019年9月5日

研究の完了 (実際)

2019年10月1日

試験登録日

最初に提出

2021年4月10日

QC基準を満たした最初の提出物

2021年4月26日

最初の投稿 (実際)

2021年4月29日

学習記録の更新

投稿された最後の更新 (実際)

2021年4月29日

QC基準を満たした最後の更新が送信されました

2021年4月26日

最終確認日

2021年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 2017-68001-26354 NIFA

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

Six months after publication

IPD 共有アクセス基準

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.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Garden installationの臨床試験

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