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

NCT04253938 | Unknown

• 1 other identifier: 2019-05-0141
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Feeding Score

  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).

  Up to 1 year

Secondary Outcomes (2)

• Food insecurity

  Up to 1 year

• Nutrition history

  Up to 1 year

Study Arms (1)

Education

OTHER

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.

Other: Education

Interventions

Education OTHER

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

Education

Eligibility Criteria

• Age: 1 Week - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

Dell Medical School

Austin, Texas, 78715, United States

RECRUITING

MeSH Terms

Conditions

Feeding Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Keli Hawthorne, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: February 5, 2020
• Study Start: December 15, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)