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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04253938
Enrollment
200
Registered
2020-02-05
Start date
2019-12-15
Completion date
2021-06-01
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Feeding Behavior

Brief 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.

Interventions

OTHEREducation

Subjects will be provided education about AAP approved feeding practices for infants 1 to 12 months of age.

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 12 Months
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Feeding ScoreUp to 1 yearThe 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).

Secondary

MeasureTime frameDescription
Food insecurityUp to 1 yearFood insecurity questionnaire (from a validated short form of the Food Security Scale, Blumberg et al, Am J Public Health, 1999)
Nutrition historyUp to 1 yearIntake amount and frequency (solid foods, breastfeeding, infant formula), type of infant formula, vitamins and/or iron drops. Feeding practices questions are based on a similar validated survey by Burkhart et al, Clin Pediatri, 2012 and a Perrigo survey from 2018.

Countries

United States

Contacts

Primary ContactKeli Hawthorne, MS
keli.hawthorne@austin.utexas.edu512-495-4700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026