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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.


Condition or disease Intervention/treatment Phase
Feeding Behavior Other: Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Feeding Practices in Latin American Infants at a Medical Home in Austin, Texas
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04253938


Contacts
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Contact: Keli Hawthorne, MS 512-495-4700 keli.hawthorne@austin.utexas.edu

Locations
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United States, Texas
Dell Medical School Recruiting
Austin, Texas, United States, 78715
Contact: Keli Hawthorne, MS    512-495-4700    keli.hawthorne@austin.utexas.edu   
Principal Investigator: Ana Avalos, MD         
Sponsors and Collaborators
University of Texas at Austin
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Responsible Party: Ana M. Avalos, Assistant Professor, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT04253938    
Other Study ID Numbers: 2019-05-0141
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No