Unintentional Overfeeding of Formula Fed Infants

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.

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Key information

Conditions

Childhood Obesity Body Weight Infant Development Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808-4124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Focus Group Recommendations to Improve Infant Formula Preparation Instructions

Time frame: Day 1

Focus groups were used to evaluate and provide recommendations to improve the reading and comprehension of powdered infant formula package preparation instructions. Five focus groups provided primary recommendations. The percentage of focus group participants reporting specific recommendations are summarized.
Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight

Time frame: Day 1

Percent Error of the formula weight prepared by Phase 2 study participants as compared to the expected formula weight from the manufacturer's label. Phase 2 participants were either randomly assigned the standard instructions or the instructions that were modified as a result of the Phase 1 focus groups.

Percent error was calculated as the measured formula weight prepared by Phase 2 study participants subtracted from the expected formula weight found on the manufacturer's label with that result being divided by the expected formula weight found on the manufacturer's label. The final result is multiplied by 100 to provide the percent error. Percent error is presented as opposed to formula weight because each participant prepared two 2, 4, 6, and 8 oz bottles. Percent error analysis includes all bottles prepared regardless of size.

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Registry information

Acronym: Whoa Baby

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Mar 8, 2016
Registry last updated: Jan 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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