制定和测试儿童保育中循证肥胖预防的实施策略
2026年9月9日 更新者：University of Arkansas
Investigators will pilot test the impact of an enhanced implementation strategy on implementation and child health outcomes using continuous formative evaluation. Investigators will test the hypothesis that better fidelity to the implementation strategy (WISE) is positively related to child outcomes (e.g., child fruit and vegetable intake, BMI).
研究概览
详细说明
Investigators will determine whether the enhanced strategy is feasible, acceptable, and demonstrates improved implementation, fidelity, and sustainability using a Hybrid Type 3 implementation design. Investigators expect that the effectiveness of WISE on child outcomes will vary by the level of implementation fidelity, and a Hybrid 3 design allows for us to explore this hypothesis).
研究类型
介入性
注册 (实际的)
38
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
-
-
Arkansas
-
Little Rock、Arkansas、美国、72205
- University of Arkansas for Medical Sciences
-
-
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
Inclusion Criteria:
- Early childhood educators from our partnering Head Start agency
Exclusion Criteria:
- Secondary Outcome Inclusion Criteria:
- Children aged 3-5 years old in our partnering Head Start agency
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 |
|---|---|
|
有源比较器：Basic WISE strategy
These participants will be asked to implement the basic WISE strategy used in previous studies. |
An enhanced implementation strategy for evidence-based obesity prevention in childcare |
|
实验性的：Enhanced WISE strategy
These participants will be asked to implement the enhanced WISE strategy. |
An enhanced implementation strategy for evidence-based obesity prevention in childcare |
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 |
|---|---|---|
|
WISE Fidelity Scores for Use of Evidence-Based Obesity Practices
大体时间：From Baseline Up to 8 months
|
The WISE fidelity measure will be used across the school year. The WISE fidelity instrument is rated on a 1 to 4 scale with 4 representing the highest level of fidelity. Each core component is assessed with 2 items. Average fidelity scores above 3 are considered to reflect adequate fidelity on a component. That is, the 2 items on each fidelity component were averaged; an average of above 3 was considered as having achieved fidelity. We are reporting on the total number of classrooms that achieved fidelity in each condition at the spring (final assessment) for the evidence-based practices of WISE. |
From Baseline Up to 8 months
|
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.
- Bell AC, Davies L, Finch M, Wolfenden L, Francis JL, Sutherland R, Wiggers J. An implementation intervention to encourage healthy eating in centre-based child-care services: impact of the Good for Kids Good for Life programme. Public Health Nutr. 2015 Jun;18(9):1610-9. doi: 10.1017/S1368980013003364. Epub 2014 Jan 9.
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- Khoo HE, Prasad KN, Kong KW, Jiang Y, Ismail A. Carotenoids and their isomers: color pigments in fruits and vegetables. Molecules. 2011 Feb 18;16(2):1710-38. doi: 10.3390/molecules16021710.
- Darvin ME, Fluhr JW, Caspers P, van der Pool A, Richter H, Patzelt A, Sterry W, Lademann J. In vivo distribution of carotenoids in different anatomical locations of human skin: comparative assessment with two different Raman spectroscopy methods. Exp Dermatol. 2009 Dec;18(12):1060-3. doi: 10.1111/j.1600-0625.2009.00946.x.
- Blume-Peytavi U, Rolland A, Darvin ME, Constable A, Pineau I, Voit C, Zappel K, Schafer-Hesterberg G, Meinke M, Clavez RL, Sterry W, Lademann J. Cutaneous lycopene and beta-carotene levels measured by resonance Raman spectroscopy: high reliability and sensitivity to oral lactolycopene deprivation and supplementation. Eur J Pharm Biopharm. 2009 Sep;73(1):187-94. doi: 10.1016/j.ejpb.2009.04.017. Epub 2009 May 13.
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- Levi J, Segal L, St. Laurent R, Rayburn J. The state of obesity: Better policies for a healthier America. Princeton (NJ): Robert Wood Johnson Foundation and Trust for America's Health; 2014 Sept. Available from: http://www.rwjf.org/en/library/research/2014/09/the-state-of-obesity.html
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- Frisvold DE, Lumeng JC. Expanding exposure: Can increasing the daily duration of head start reduce childhood obesity? The Journal of Human Resources 46(2): 373-402, 2011.
- Faith MS, Pietrobelli A, Heo M, Johnson SL, Keller KL, Heymsfield SB, Allison DB. A twin study of self-regulatory eating in early childhood: estimates of genetic and environmental influence, and measurement considerations. Int J Obes (Lond). 2012 Jul;36(7):931-7. doi: 10.1038/ijo.2011.258. Epub 2012 Jan 17.
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- Dev DA, Speirs KE, McBride BA, Donovan SM, Chapman-Novakofski K. Head Start and child care providers' motivators, barriers and facilitators to practicing family-style meal service. Early Childhood Research Quarterly 29(4): 649-659, 2014.
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- Whiteside-Mansell L, Bradley R, Conners N, Bokony P. The family map: Structured family interview to identify risks and strength in Head Start families. NHSA Dialog 10(3-4): 189-209, 2007.
- Darvin ME, Sterry W, Lademann J, Vergou T. The role of carotenoids in human skin. Molecules 16(12): 10491-10506, 2011.
- Darvin ME, Gersonde I, Meinke M, Sterry W, Lademann J. Non-invasive in vivo determination of the carotenoids beta-carotene and lycopene concentrations in the human skin using the Raman spectroscopic method. Journal of Physics D: Applied Physics 38(15): 2696, 2005.
- Swindle T, McBride NM, Selig JP, Johnson SL, Whiteside-Mansell L, Martin J, Staley A, Curran GM. Stakeholder selected strategies for obesity prevention in childcare: results from a small-scale cluster randomized hybrid type III trial. Implement Sci. 2021 May 1;16(1):48. doi: 10.1186/s13012-021-01119-x.
- Swindle T, Selig JP, Rutledge JM, Whiteside-Mansell L, Curran G. Fidelity monitoring in complex interventions: a case study of the WISE intervention. Arch Public Health. 2018 Aug 29;76:53. doi: 10.1186/s13690-018-0292-2. eCollection 2018.
- Swindle T, Johnson SL, Whiteside-Mansell L, Curran GM. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial. Implement Sci. 2017 Jul 18;12(1):90. doi: 10.1186/s13012-017-0624-6.
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)
2020年3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)
2026年10月1日
上次提交的符合 QC 标准的更新
2026年9月9日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 205335
- K01DK110141-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.