Trials / Unknown
UnknownNCT04253938
Evaluation of Feeding Practices in Latin American Infants at a Medical Home in Austin, Texas
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- University of Texas at Austin · Academic / Other
- Sex
- All
- Age
- 1 Week – 12 Months
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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. The infant's anthropometrics and medical history will be obtained from the EMR. This pilot data would be the foundation for a larger, more intensive study to determine prevalence of inappropriate feeding strategies among Latin American families and best strategies to educate and inform.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Education | Subjects will be provided education about AAP approved feeding practices for infants 1 to 12 months of age. |
Timeline
- Start date
- 2019-12-15
- Primary completion
- 2020-12-01
- Completion
- 2021-06-01
- First posted
- 2020-02-05
- Last updated
- 2020-02-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04253938. Inclusion in this directory is not an endorsement.