Recruiting

Observational Study

Sponsor:

University of Texas at Austin

Code:

NCT04253938

Conditions

Feeding Behavior

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

Interventions

Education

Study Details

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.

Conditions

Feeding Behavior

Study ID

NCT04253938

Start date

Dec 15, 2019

Status verified date

Jan, 2020

Completion date

Jun 1, 2021

Anticipated

Primary completion date

Dec 1, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Accepted

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

Study Design

Enrollment

200 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Education

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.

Interventions

Education

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

Primary outcome measure

  • Feeding Score [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Keli Hawthorne, MS

512-495-4700keli.hawthorne@austin.utexas.edu

Locations

Dell Medical School

Recruiting

Austin, Texas, United States, 78715

Contacts

Keli Hawthorne, MS

512-495-4700keli.hawthorne@austin.utexas.edu

Principal Investigator:

Ana Avalos, MD

More Information

Sponsor

University of Texas at Austin

Last update posted

Feb 5, 2020

Last verified

Jan, 2020

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2020-02-05.