Unintentional Overfeeding of Formula Fed Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Focus Group Recommendations to Improve Infant Formula Preparation Instructions
研究概览
简要总结
Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the U.S. are fed infant formula. Despite an almost identical energy density between infant formula and breast milk, formula fed infants experience greater weight gain in the first year of life. The investigators propose that unintentional overfeeding, of nearly one additional day of calories per week, due to the "over-scooping" of powdered formula contributes significantly to this phenomenon and potentially to the early development of childhood obesity, a significant public health problem.
详细描述
In the proposed study the investigators will assess the literacy and understanding of individuals to follow commercially available infant formula instructions. The investigators will collaborate with the LA CaTS Health Literacy Core to improve the reading and comprehension of the manufacturer package instruction, and will solicit the input of caregivers and key stakeholders to inform the development of educational intervention around infant feeding. Following modification of infant formula preparation instructions, the investigators will conduct a randomized controlled trial that will test the efficacy of the modified instructions on infant overfeeding in comparison with the manufacturer package instructions. One hundred and fifty participants will be asked to complete one study visit during which they will be asked to measure various serving sizes of infant formula following either the manufacturer package instructions or the modified instructions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age
- •Willing to participate in 1 assessment visit at Pennington Biomedical Research Center
- •English speaking
排除标准
- •<18 years of age
- •Not willing to participate in 1 assessment visit at Pennington Biomedical Research Center
- •Non-English speaking
结局指标
主要结局
Focus Group Recommendations to Improve Infant Formula Preparation Instructions
时间窗: Day 1
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.
Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight
时间窗: Day 1
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.
次要结局
未报告次要终点
研究者
Anne Gilmore
Postdoctoral Fellow
Pennington Biomedical Research Center