制定和测试儿童保育中循证肥胖预防的实施策略
2021年8月10日 更新者：University of Arkansas
调查人员将使用持续的形成性评估试点测试强化实施策略对实施和儿童健康结果的影响。
调查人员将检验这样一个假设，即更好地忠实于实施策略 (WISE) 与儿童结果（例如，儿童水果和蔬菜摄入量、BMI）呈正相关。
研究概览
详细说明
调查人员将确定增强策略是否可行、可接受，并使用混合类型 3 实施设计展示改进的实施、保真度和可持续性。
调查人员预计 WISE 对儿童结果的有效性会因实施保真度的不同而有所不同，而 Hybrid 3 设计允许我们探索这一假设）。
研究类型
介入性
注册 (实际的)
696
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Arkansas
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Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
纳入标准：
- 来自我们合作启蒙机构的幼儿教育工作者
排除标准：
- 次要结果纳入标准：
- 我们的合作启蒙机构中 3-5 岁的儿童
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：基本 WISE 策略
这些参与者将被要求实施以前研究中使用的基本 WISE 策略。
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儿童保育中循证肥胖预防的强化实施策略
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实验性的：增强型 WISE 策略
这些参与者将被要求实施增强的 WISE 战略。
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儿童保育中循证肥胖预防的强化实施策略
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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教育工作者观察到的使用循证肥胖实践的实施保真度分数的变化
大体时间：从基线到 8 个月
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WISE 保真度衡量标准将在整个学年使用。
WISE 保真度仪器按 1 到 4 等级进行评级，其中 4 代表最高级别的保真度。
每个核心组件用 2 个项目进行评估。
高于 3 的平均保真度分数被认为反映了组件的足够保真度。
也就是说，对每个保真度组件的 2 个项目进行平均；平均超过 3 被认为已达到保真度。
我们正在报告春季（最终评估）在每个条件下实现 WISE 循证实践保真度的教室总数。
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从基线到 8 个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Taren M Swindle, PhD、University of Arkansas
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Sigman-Grant M, Christiansen E, Fernandez G, Fletcher J, Johnson SL, Branen L, Price BA. Child care provider training and a supportive feeding environment in child care settings in 4 states, 2003. Prev Chronic Dis. 2011 Sep;8(5):A113. Epub 2011 Aug 15.
- Woolf SH, Johnson RE. The break-even point: when medical advances are less important than improving the fidelity with which they are delivered. Ann Fam Med. 2005 Nov-Dec;3(6):545-52. doi: 10.1370/afm.406.
- Glasgow RE. What types of evidence are most needed to advance behavioral medicine? Ann Behav Med. 2008 Feb;35(1):19-25. doi: 10.1007/s12160-007-9008-5. Epub 2008 Feb 12.
- Clarke AM, Bunting B, Barry MM. Evaluating the implementation of a school-based emotional well-being programme: a cluster randomized controlled trial of Zippy's Friends for children in disadvantaged primary schools. Health Educ Res. 2014 Oct;29(5):786-98. doi: 10.1093/her/cyu047. Epub 2014 Aug 11.
- Atkins MS, Frazier SL, Leathers SJ, Graczyk PA, Talbott E, Jakobsons L, Adil JA, Marinez-Lora A, Demirtas H, Gibbons RB, Bell CC. Teacher key opinion leaders and mental health consultation in low-income urban schools. J Consult Clin Psychol. 2008 Oct;76(5):905-8. doi: 10.1037/a0013036.
- Noell GH, Witt JC, LaFleur LH, Mortenson BP, Ranier DD, LeVelle J. Increasing intervention implementation in general education following consultation: a comparison of two follow-up strategies. J Appl Behav Anal. 2000 Fall;33(3):271-84. doi: 10.1901/jaba.2000.33-271.
- Rabin BA, Glasgow RE, Kerner JF, Klump MP, Brownson RC. Dissemination and implementation research on community-based cancer prevention: a systematic review. Am J Prev Med. 2010 Apr;38(4):443-56. doi: 10.1016/j.amepre.2009.12.035.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月26日
初级完成 (实际的)
2019年12月15日
研究完成 (实际的)
2019年12月15日
研究注册日期
首次提交
2017年2月20日
首先提交符合 QC 标准的
2017年3月3日
首次发布 (实际的)
2017年3月9日
研究记录更新
最后更新发布 (实际的)
2021年9月5日
上次提交的符合 QC 标准的更新
2021年8月10日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.