Pattern - Reach Aim 2
2022年10月21日 更新者：Duke University
Pilot Adaptive Tool To Encourage Risk Reduction in iNfancy (PATTERN)
The purpose of this research study is to learn about different approaches to promoting healthy growth among infants, and understanding parents' likes and dislikes of an approach to reducing risk factors for obesity later in life.
The study includes filling out some forms with questions about your baby and your thoughts about your baby's growth and health, and engaging in a pattern of changes in or prevention of risk factors in the first year of life.
Parents will receive information about changes and some tools and materials to take home with them.
Some parents may receive phone calls between visits as well.
The study takes place from soon after birth through the infant's age of 9 months.
The estimated total time of interaction between the study staff and parents during the study period is 4 hours.
研究概览
详细说明
As this is a dyad study, each dyad is considered to be a participant and demographic information will reflect the infant in the dyad, per parent report.
研究类型
介入性
注册 (实际的)
28
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
-
-
North Carolina
-
Durham、North Carolina、美国、27705
- Duke University
-
-
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
2周 至 2个月 (孩子)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Non-Hispanic black (as documented in MaestroCare) parents/caregivers with; infants ages 2 weeks to 2 months of age; infant birthweight between 2500g and 4000g; infant gestational age is at least 36 weeks
Exclusion Criteria:
- non-English-speaking; infant with serious disease or disorder affecting growth and nutrition
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：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Response
|
Parents pick from a menu of behavior changes
|
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其他：Non-response
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Stepped up phone interaction with parents based on menu of behavior changes
|
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 |
|---|---|---|
|
Number of Participants Satisfied or Very Satisfied With Information Given to Them, as Measured by Follow up Questionnaire
大体时间：3 to 6 months after baseline assessment
|
Completed Likert scale with 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5=very satisfied
|
3 to 6 months after baseline assessment
|
|
Percentage of Successful Contacts With Families Via Telephone and/or in Clinic
大体时间：3 to 6 months after baseline assessment
|
Number of successful contacts with families divided by number of attempts to contact by research staff x 100
|
3 to 6 months after baseline assessment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent of Participants Exclusively Breastfeeding at 4 Months Postnatal Age
大体时间：3 to 6 months after baseline assessment
|
Dyad caregivers were asked what type of milk was being consumed by the infant, with 4 options available: 1) Formula only, 2) Mostly formula and some breast milk, 3) Mostly breast milk, but some formula, or 4) Breast milk only.
|
3 to 6 months after baseline assessment
|
|
Percent of Participants Delaying Complementary Feeding Until 4 Months Postnatal Age
大体时间：3 to 6 months after baseline assessment
|
Dyads caregivers were asked, "Is your baby eating solid foods yet or do you put any solid foods in the bottle?", with 2 options available: 1) Yes or 2) No
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3 to 6 months after baseline assessment
|
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Percent of Participants Reporting "Never" Engaging in Screentime While Feeding and With '0' Minutes of Active TV Watching at 4 Months Postnatal Age
大体时间：3 to 6 months after baseline assessment
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Dyad caregivers were asked "I watch TV or look at or use my phone while feeding my baby" and responded with one of 5 Likert-scale responses: 1) Never, 2) Seldom, 3) Half of the time, 4) Most of the time, 5) Always
|
3 to 6 months after baseline assessment
|
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：Charles Wood、Duke University
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)
2020年5月7日
初级完成 (实际的)
2021年5月4日
研究完成 (实际的)
2021年5月4日
研究注册日期
首次提交
2019年12月30日
首先提交符合 QC 标准的
2019年12月30日
首次发布 (实际的)
2020年1月2日
研究记录更新
最后更新发布 (实际的)
2022年11月16日
上次提交的符合 QC 标准的更新
2022年10月21日
最后验证
2022年10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.