Unintentional Overfeeding of Formula Fed Infants (Whoa Baby)
研究概览
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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Louisiana
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Baton Rouge、Louisiana、美国、70808-4124
- Pennington Biomedical Research Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Phase 1 will utilize qualitative data gathered from focus groups to direct the modification of infant formula manufacturer preparation instructions to enhance user understanding and accuracy. The modified instructions will be used in Phase 2.
Up to 150 individuals will be enrolled in Phase 2 to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.
描述
Inclusion Criteria:
- ≥18 years of age
- Willing to participate in 1 assessment visit at Pennington Biomedical Research Center
- English speaking
Exclusion Criteria:
- <18 years of age
- Not willing to participate in 1 assessment visit at Pennington Biomedical Research Center
- Non-English speaking
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Phase 1
Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center.
Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.
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Phase 2
Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.
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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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Focus Group Recommendations to Improve Infant Formula Preparation Instructions
大体时间：Day 1
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Focus groups were used to evaluate and provide recommendations to improve the reading and comprehension of powdered infant formula package preparation instructions.
Five focus groups provided primary recommendations.
The percentage of focus group participants reporting specific recommendations are summarized.
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Day 1
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Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight
大体时间：Day 1
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Percent Error of the formula weight prepared by Phase 2 study participants as compared to the expected formula weight from the manufacturer's label. Phase 2 participants were either randomly assigned the standard instructions or the instructions that were modified as a result of the Phase 1 focus groups. Percent error was calculated as the measured formula weight prepared by Phase 2 study participants subtracted from the expected formula weight found on the manufacturer's label with that result being divided by the expected formula weight found on the manufacturer's label. The final result is multiplied by 100 to provide the percent error. Percent error is presented as opposed to formula weight because each participant prepared two 2, 4, 6, and 8 oz bottles. Percent error analysis includes all bottles prepared regardless of size. |
Day 1
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合作者和调查者
调查人员
- 首席研究员：Anne Gilmore, Ph.D.、Pennington Biomedical Research Center
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.