Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study)
赞助:
University of Pennsylvania
合作者:
信息的提供 (责任方):
Jianghong Liu，University of Pennsylvania
| 追踪信息 | |||
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| 首次提交日期 ICMJE | July 30, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | May 15, 2018 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Sleep[ Time Frame: 3 months ] For parent sleep patterns, we will use the Pittsburgh Sleep Quality Index to evaluate changes. For children's sleep, we will use the Child Sleep Habits questionnaire. |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Effect of Omega-3 Fatty Acids on Sleep and Behavior (Pilot Study) | ||
| 正式标题 ICMJE | Pilot Study on the Effects of Omega-3 Fatty Acid Supplements on Sleep and Behavior of Mother-child Pairs | ||
| 简要概况 | The aim of this feasibility study is to determine whether a nutritional intervention in children and their parents can improve their sleep quality and behavior. The study is a randomized, double-blind, placebo-controlled parallel trial of omega-3 supplementation to children and their mothers. |
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| 详细说明 | Previous studies show omega-3 fatty acid supplements improve adolescent's antisocial behavior. However it is less known whether the same effect could be achieved in younger children. Furthermore it is not known whether omega-3 fatty acids could also improve parental behavior and parenting style which could further reduce behavioral problems in children. Moreover, we recently found that children who consume fish more frequently have less sleep problems but it is not known whether omega-3 supplements could also potentially improve children's sleep. We aim to test several hypotheses in this random controlled trial of omega-3 fatty acids. The study design will consist of a double-blind, randomized placebo-controlled trial of children and their caregivers in a community sample in the city of Philadelphia. It will utilize a random parallel design, in which child and mother pairs will be randomly assigned to either omega-3 supplementation (treatment condition) or a placebo (control condition). This results in 2 groups: (1) child and caregiver both receiving omega-3 and (2) both parent and child receiving the placebo. Treatment will last 45 days. Assessments will take place at 0 months (baseline), 45 days (end of supplementation) and 90 days (45 days after the end of treatment). | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | N/A | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Factorial Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
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| 招募信息 | |||
| 招募状态 ICMJE | Recruiting | ||
| 预计入组 ICMJE |
72 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | June 30, 2019 | ||
| 预计主要完成日期 | June 30, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - child between ages 5-9 with mother available to participate in intervention study Exclusion Criteria: - intellectual disability - significant psychiatric and physical illness - extensive use of nutritional supplements within the past three months - seafood allergy - diabetes | ||
| 性别 |
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| 年龄 | 最小年龄：5 Years ，最大年龄：9 Years | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | United States | ||
| 管理信息 | 数据检测委员会 | ||
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Jianghong Liu，University of Pennsylvania | ||
| 研究赞助商 ICMJE | University of Pennsylvania | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | University of Pennsylvania | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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