健康的孩子,健康的家庭:父母发挥作用
2022年3月8日 更新者:Cornell University
健康的孩子,健康的家庭:父母发挥作用:一项随机对照试验
健康儿童、健康家庭的影响:父母发挥作用! (HCHF) 与延迟干预对照组相比,将调查参加扩大食品和营养教育计划的低收入父母如何使用有效的育儿实践来影响儿童的健康饮食和积极游戏行为。
研究概览
详细说明
健康的孩子,健康的家庭:父母有所作为! (HCHF) 课程是康奈尔大学为父母和看护人开设的课程,重点关注最有可能帮助孩子避免不健康体重增加的行为。
这些行为包括喝水或牛奶而不是甜味饮料、多吃蔬菜和水果、积极玩耍、少吃高脂肪和高糖食物、限制看屏幕的时间以及合理的份量。
8 节课程采用以学习者为中心的对话方法、实践活动和角色扮演。
该研究将包括 300 名参与者,他们有 3-5 岁的幼儿参加纽约市的启蒙计划和儿童保育计划,采用随机对照设计。
在第 1 期(9 周),一半的小组将接受 HCHF 教育(即时教育,IE),另一半将作为对照组,不接受任何教育(延迟教育,DE)。
在第 2 期(9 周),DE 将接受教育; IE 将不接受任何教育,并在第 2 和第 3 期进行纵向跟踪。
在第 3 期(16 周),两组都不会接受教育,并且都将进行纵向跟踪。
将使用经过验证的措施在每个时间点收集数据,包括研究人员开发的 HCHF 清单和评估育儿喂养方式、父母的食物行为、儿童的食物行为以及父母围绕肥胖预防行为的自我效能的补充措施。
据推测,HCHF 前后的变化将大于对照组,并且行为的变化将在教育后保留。
研究类型
介入性
注册 (实际的)
391
阶段
- 不适用
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
- 孩子
- 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:有 3-5 岁幼儿的父母/看护人
- 排除标准:任何没有 3-5 岁孩子的人
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:交叉作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:立即干预
即时教育 (IE) 小组将接受干预,健康的儿童,健康的家庭:父母有所作为!在第 1 期。
在第 2 期,IE 将不接受任何教育,并将在第 2 期和第 3 期进行纵向跟踪。
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健康的孩子,健康的家庭:父母有所作为!干预措施是由研究人员针对低收入父母和看护人开发的,重点关注最有可能帮助儿童避免不健康的体重增加的行为。
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有源比较器:延迟干预
延迟教育 (DE) 组将作为第 1 期的对照,不接受任何干预。
在第 2 期,治疗将交叉进行,因此 DE 将收到健康的孩子,健康的家庭:父母有所作为!干涉。
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健康的孩子,健康的家庭:父母有所作为!干预措施是由研究人员针对低收入父母和看护人开发的,重点关注最有可能帮助儿童避免不健康的体重增加的行为。
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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 |
---|---|---|
健康儿童、健康家庭清单
大体时间:长达 8 个月
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该清单是一个包含 16 项的工具,用于评估父母/看护人在食物和身体活动方面的养育和个人行为,以及目标儿童的食物和身体活动行为。
该清单要求家长报告在 5 点李克特式量表上的练习频率(每天/每周/每月)。
这些结构衡量父母的饮食质量和身体活动、儿童的饮食质量和身体活动以及养育方式。
仪器上的每个问题都被转换为一个数值,1 表示最不理想的回答,5 表示最理想的回答。
将整个工具的值相加(范围 1 - 80 - 仅包括至少具有一个响应的清单)并除以具有响应的项目数 (0 - 16),得到平均分数范围 0 - 5. 每个分量表内的问题处理方式相同,分量表范围为0-5。
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长达 8 个月
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综合喂养习惯问卷 (CFPQ)
大体时间:长达 8 个月
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从最初的 CFPQ 中选择了六个与干预学习目标一致的子量表(24 个项目)。
子量表评估的结构包括鼓励平衡和多样性、使用食物作为奖励、父母允许孩子控制饮食、父母榜样、父母对孩子消耗更多食物的压力以及家庭环境。
6 个项目的响应选项包括 Likert 量表的频率(从不总是),18 个项目的响应选项包括 Likert 量表(强烈不同意到强烈同意)。
每个响应都转换为一个数值,1 表示最不理想的选项,5 表示最理想的选项。
然后将这些值相加(范围 0 - 120)并除以具有响应的项目数,得到 0 - 5 的平均量表分数范围。每个子量表中的项目以相同的方式处理,与子刻度范围为 0 - 5。
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长达 8 个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
父母自我效能感
大体时间:长达 8 个月
|
选择了四个项目来评估父母对干预措施中所涉及行为的影响力:儿童的身体活动;以及水果、蔬菜和含糖饮料的摄入量。
项目响应包括 5 点李克特式量表(不确定到非常确定)。
每个问题都转换为一个数值,1 表示最不理想,5 表示最理想。
这些值相加(范围 0 - 20)并除以具有响应的项目数 (0 - 4),得到 0 - 5 的平均量表分数范围。
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长达 8 个月
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含糖饮料和食品的食用频率
大体时间:长达 8 个月
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从 10 个项目的仪器中选择了 5 个项目;精选商品特别关注含糖饮料和添加糖分的食品。
父母报告孩子每天食用的次数。
根据最初的反应,设计了一个评分系统,将零摄入量(最理想)的反应分配为 7,每天> 2.5 次(最不希望)的反应为 1。
然后将响应值相加(范围 0 - 35)并除以 5,得到 0 - 7 的平均量表分数范围。
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长达 8 个月
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父母的食物选择行为
大体时间:长达 8 个月
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使用食物行为检查表中的两个量表来评估父母自我报告的水果和蔬菜食物摄入量(9 项)和整体饮食质量(4 项)。
九个项目有李克特类型的反应,其中 8 个是从不到总是(得分 1-4),一个从差到极好(得分 1-5),在所有情况下得分越高是最理想的。
对两项的回答是否或是,分别记 1 分或 5 分。
两个项目询问每天消耗的份数,并分配给提供的值。
水果和蔬菜 9 项量表响应值相加(范围 = 1 -(26+2 个频率响应的总和)。
饮食质量 4 项量表响应值相加(范围 1 - 17)。
每个量表的总和除以量表中的项目数,得出 9 项量表的平均量表得分范围为 0-7,4 项量表的平均量表得分范围为 0-4.25。
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长达 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:Jamie S Dollahite、Cornell University
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。
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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)
2017年1月1日
初级完成 (实际的)
2018年8月30日
研究完成 (实际的)
2019年12月31日
研究注册日期
首次提交
2018年9月7日
首先提交符合 QC 标准的
2019年11月25日
首次发布 (实际的)
2019年11月27日
研究记录更新
最后更新发布 (实际的)
2022年3月22日
上次提交的符合 QC 标准的更新
2022年3月8日
最后验证
2022年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
将提供所有主要和次要结果测量的去标识化个人参与者数据。
IPD 共享时间框架
2020
IPD 共享访问标准
数据访问请求将由未参与该研究的康奈尔大学营养科学系的调查人员审查。
请求者将被要求签署数据访问协议。
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
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.
健康儿童 健康家庭的临床试验
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University of Texas at AustinUniversity of Maryland; The University of Texas Health Science Center at San Antonio; The University...主动,不招人
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University of Wisconsin, MadisonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)主动,不招人
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University of California, DavisUniversity of California, Irvine完全的
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University of California, San DiegoFamily Health Centers of San Diego; UCSD Center for Community Health招聘中
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Kaohsiung Medical UniversityNational Science Council, Taiwan完全的