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

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ClinicalTrials.gov Identifier: NCT04253938
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ana M. Avalos, University of Texas at Austin

Tracking Information
First Submitted Date  ICMJE January 9, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE December 15, 2019
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
Feeding Score [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
  • Food insecurity [ Time Frame: Up to 1 year ]
    Food insecurity questionnaire (from a validated short form of the Food Security Scale, Blumberg et al, Am J Public Health, 1999)
  • Nutrition history [ Time Frame: Up to 1 year ]
    Intake 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Feeding Practices in Latin American Infants at a Medical Home in Austin, Texas
Official Title  ICMJE Evaluation of Feeding Practices in Latin American Infants at a Medical Home in Austin, Texas
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Feeding Behavior
Intervention  ICMJE Other: Education
Subjects will be provided education about AAP approved feeding practices for infants 1 to 12 months of age.
Study Arms  ICMJE 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.

Intervention: Other: Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 12 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Keli Hawthorne, MS 512-495-4700 keli.hawthorne@austin.utexas.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04253938
Other Study ID Numbers  ICMJE 2019-05-0141
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ana M. Avalos, University of Texas at Austin
Study Sponsor  ICMJE University of Texas at Austin
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Texas at Austin
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP