Unintentional Overfeeding of Formula Fed Infants

NCT ID: NCT02701868

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 171 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-04-30

Brief Summary

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.

Detailed 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.

Conditions

Childhood Obesity; Infant Development

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Phase 1

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.

No interventions assigned to this group

Phase 2

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Anne Gilmore

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Gilmore, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

PBRC2016-002

Identifier Type: -

Identifier Source: org_study_id