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临床试验/NCT04253938
NCT04253938Unknown不适用

Evaluation of Feeding Practices in Latin American Infants at a Medical Home in Austin, Texas

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年12月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
Feeding Score

研究概览

简要总结

The purpose of this study is to determine the methods of formula preparation and feeding practices in Latin American households in the first 12 months of life. There is limited published information on the feeding practices of infants in disadvantaged households, and still less information is available regarding disadvantaged Latin American households.

Studies have shown that certain feeding practices such as diluting infant formula, warming bottles in a microwave, or storing partially used bottles in the refrigerator can be dangerous for the infant. Previous pilot data in other states have documented that up to 15-21% of parents dilute infant formula. Motives for doing so included an attempt to avoid infant hunger, save money, or make formula last longer.

详细描述

The study will include 2 visits, both occurring at the CommUnity Care clinic during the infant's regularly scheduled doctor's visit. Study visits will coincide with the American Academy of Pediatrics' (AAP) recommendations for timing of visits in the first year of life: prior to 2 months of age a baby will be scheduled for 2 visits (usually at 1 and 2 weeks of life), with subsequent well-child visits scheduled for 2, 4, 6, and 9 months of age. The investigators will seek to enroll subjects (Parent/Caregiver of infant less than 1 year of age) when the child attends any visit prior to the 9 month visit so that the investigators can complete both study visits prior to 1 year of age.

Visit 1 - Parent/Caregiver will complete a questionnaire about breastfeeding/formula feeding practices and food insecurity. The questionnaire includes a nutrition history, asking how much formula is consumed, number of times they are breastfed per day, what types and amounts of solid foods are consumed, and if vitamins and/or iron drops are given (including frequency and amount). After the questionnaire, the participant will be asked to demonstrate how they typically prepare infant formula. Finally, the PI or designee will provide a brief education about appropriate feeding practices as recommended by the AAP.

The study will include 2 visits, both occurring at the CommUnity Care clinic during the infant's regularly scheduled doctor's visit. Study visits will coincide with the American Academy of Pediatrics' (AAP) recommendations for timing of visits in the first year of life: prior to 2 months of age a baby will be scheduled for 2 visits (usually at 1 and 2 weeks of life), with subsequent well-child visits scheduled for 2, 4, 6, and 9 months of age. The investigators will seek to enroll subjects (Parent/Caregiver of infant less than 1 year of age) when the child attends any visit prior to the 9 month visit so that the investigators can complete both study visits prior to 1 year of age.

Visit 1 - Parent/Caregiver will complete a questionnaire about breastfeeding/formula feeding practices and food insecurity. The questionnaire includes a nutrition history, asking how much formula is consumed, number of times they are breastfed per day, what types and amounts of solid foods are consumed, and if vitamins and/or iron drops are given (including frequency and amount). After the questionnaire, the participant will be asked to demonstrate how they typically prepare infant formula. Finally, the PI or designee will provide a brief education about appropriate feeding practices as recommended by the AAP. This will include appropriate formula preparation methods, use of juice, introduction of cow's milk and solids, as well as basic nutrition information.

Visit 2 - If the family returns for a clinic visit again before the child turns 1 year of age, the same procedures as Visit 1 will be performed, including reinforcement of education.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
1 Week 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Caregivers of Latin American infants who are 9 months of age or younger
  • Patients at a local CommUnity Care Clinic

排除标准

  • Caregivers of Latin American infants over 9 months of age
  • Infants who are not Latin American
  • Infants with with significant underlying health problems that require feeding modifications such as naso-gastric feedings or concentrated feeds

结局指标

主要结局

Feeding Score

时间窗: Up to 1 year

The investigators will seek to answer the question, "Is there a difference in feeding score between first and second visit" where the feeding score is the sum of points given to 4 inappropriate liquid feeding practices (1. Overdilution of infant formula, 2. Use of sugar water, 3. Cow's milk, and 4. Juice, at 25 points each).

次要结局

  • Nutrition history(Up to 1 year)
  • Food insecurity(Up to 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana M. Avalos

Assistant Professor

University of Texas at Austin

研究点 (2)

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