Unintentional Overfeeding of Formula Fed Infants (Whoa Baby)

Pennington Biomedical Research Center

Status: Completed

Conditions: Childhood Obesity; Infant Development

Study type: Observational

Funder types: Other

Identifiers

NCT02701868

PBRC2016-002

Details and patient eligibility

About

Although breast milk is recommended exclusively until 6 months of age, two-thirds of infants in the U.S. are fed infant formula. Despite an almost identical energy density between infant formula and breast milk, formula fed infants experience greater weight gain in the first year of life. The investigators propose that unintentional overfeeding, of nearly one additional day of calories per week, due to the "over-scooping" of powdered formula contributes significantly to this phenomenon and potentially to the early development of childhood obesity, a significant public health problem.

Full description

In the proposed study the investigators will assess the literacy and understanding of individuals to follow commercially available infant formula instructions. The investigators will collaborate with the LA CaTS Health Literacy Core to improve the reading and comprehension of the manufacturer package instruction, and will solicit the input of caregivers and key stakeholders to inform the development of educational intervention around infant feeding. Following modification of infant formula preparation instructions, the investigators will conduct a randomized controlled trial that will test the efficacy of the modified instructions on infant overfeeding in comparison with the manufacturer package instructions. One hundred and fifty participants will be asked to complete one study visit during which they will be asked to measure various serving sizes of infant formula following either the manufacturer package instructions or the modified instructions.

Enrollment: 171 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ≥18 years of age
• Willing to participate in 1 assessment visit at Pennington Biomedical Research Center
• English speaking

Exclusion criteria

• <18 years of age
• Not willing to participate in 1 assessment visit at Pennington Biomedical Research Center
• Non-English speaking

Trial design

171 participants in 2 patient groups

Phase 1

Description:

Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Approximately six focus groups (each with 5-10 participants) will be conducted at the Pennington Biomedical Demonstration Kitchen over the course of approximately 3 months.

Phase 2

Description:

Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.