Building Blocks for Healthy Preschoolers
2021年5月5日 更新者：Maureen Black、University of Maryland, Baltimore
Building Blocks for Healthy Preschoolers: Child Care and Family Models
Pediatric obesity, a defining health problem of the century, leads to long-term health disparities. This application evaluates strategies to prevent health disparities early in life by developing environmental wellness-related interventions focused on child-care center staff and families.
Childcare centers provide an excellent opportunity to build healthy dietary and physical activity lifestyle habits and avoid the rapid weight gain that leads to health disparities. Building on a statewide survey among childcare centers and a pilot evaluation of an environmental intervention, this 3-cell randomized trial evaluates the impact of a staff-led wellness intervention and a staff-led and family-focused intervention, against a control condition.
調査の概要
詳細な説明
The intervention trial will be conducted in 48-55 childcare centers throughout Maryland, enrolling 864 children age 30-54 months from childcare centers serving low-income families. The aims are:
- to examine the impact of the wellness intervention individually and combined with the family intervention versus control on BMI z-score, food preferences and knowledge, and physical activity among children
- to examine the sustainability of the interventions
- to examine whether changes in outcomes measures for children's BMI z-score, gross motor skills, food preferences and knowledge, and physical activity are mediated by changes in the childcare staff wellness-related attitudes and behaviors and/or parent wellness-related attitudes and behaviors (exploratory).
Findings from the trial will inform programs and policies in childcare centers to prevent obesity and reduce disparities, and will be disseminated locally, regionally, and nationally through conferences, information briefs, social media, and peer-reviewed journal articles. The overall objective is to promote statewide strategies that reduce pediatric obesity and the long-term health disparities.
研究の種類
介入
入学 (実際)
1943
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
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Maryland
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Baltimore、Maryland、アメリカ、21201
- University of Maryland Growth and Nutrition Division
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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
18年歳以上 (大人、高齢者)
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:
- Preschooler 30-54 months
- Caregiver and childcare staff must be at least 18 years old
- Childcare center staff members willing to participate
- Licensed childcare centers serving low-income communities
- Children attending participating childcare centers (at least 3 days per week)
Exclusion Criteria:
- Caregivers and staff who do not speak or read English
- Childcare staff and preschoolers with health problems that would interfere with participation in physical activities
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：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：CHAMP group
Childcare centers randomly assigned the CHAMP group will receive an intervention that promotes physical activity in the classroom by developing gross motor skills through movement and enhances the nutritional environment in the centers by exposing preschoolers to new foods.
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The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
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実験的：CHAMP+ group
These childcare centers, also randomly assigned, will have the same intervention as the CHAMP group in addition to a parenting intervention that promotes wellness and healthy behaviors within families.
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The CHAMP only group intervention is based on "Food Friends & Mighty Moves", a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences.
In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills.
The CHAMP+ component is comprised of a curriculum of parenting, wellness, physical activity, and feeding in the home environment.
The CHAMP+ intervention will span over the course of the CHAMP intervention.
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介入なし：Control
This group will not receive theCHAMP intervention at the childcare center nor will this group receive the CHAMP+ parenting intervention.
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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 |
|---|---|---|
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Change of BMI Z-score for preschoolers
時間枠：Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Measured weight and height for the preschoolers, calculated as age and gender-specific BMI Z-score
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Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change of Physical Activity for preschoolers and childcare center staff
時間枠：Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Moderate to Vigorous Physical Activity (MVPA) based on anthropometrics
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Baseline to 6 month (Midline) Follow-up or 1 year (Post Intervention) Follow-up
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Change in Gross Motor Skills
時間枠：Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Test of Gross Motor Development-2
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
時間枠：Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Food Neophobia Scale (Caregiver report)
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
時間枠：Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Fruit & Vegetable Knowledge & Preference Test
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Change in Preschoolers to try new foods
時間枠：Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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Measured by Food Tasting Assessment
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Baseline to 6 month (Post Intervention) Follow-up or 1 year (Delayed Intervention) Follow-up
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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：Maureen M Black, PhD、University of Maryland, Baltimore
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Rahmaty Z, Johantgen ME, Storr CL, Wang Y, Black MM. Preschoolers BMI: Associations with Patterns of Caregivers' Feeding Practices Using Structural Equation Models. Child Obes. 2022 Jun 1. doi: 10.1089/chi.2022.0026. Online ahead of print.
- Armstrong B, Trude ACB, Johnson C, Castelo RJ, Zemanick A, Haber-Sage S, Arbaiza R, Black MM. CHAMP: A cluster randomized-control trial to prevent obesity in child care centers. Contemp Clin Trials. 2019 Nov;86:105849. doi: 10.1016/j.cct.2019.105849. Epub 2019 Sep 13.
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)
2016年6月17日
一次修了 (実際)
2020年3月13日
研究の完了 (実際)
2020年3月13日
試験登録日
最初に提出
2017年3月27日
QC基準を満たした最初の提出物
2017年4月6日
最初の投稿 (実際)
2017年4月12日
学習記録の更新
投稿された最後の更新 (実際)
2021年5月10日
QC基準を満たした最後の更新が送信されました
2021年5月5日
最終確認日
2021年5月1日
詳しくは
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。
CHAMPの臨床試験
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Lori EricksonChildren's Mercy Hospital Kansas City; The Gerber Foundation招待による登録
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University of TorontoUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Unity Health募集
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Indiana UniversityNational Institute on Aging (NIA)完了