Clinical trial NCT02701868: Unintentional Overfeeding of Formula Fed Infants
Official title: Unintentional Overfeeding of Formula Fed Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Infant Development
Keywords: Infant Formula
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Up to 40 individuals will be recruited to participate in focus groups at Pennington Biomedical Research Center. Phase 1 will utilize qualitative data gathered from focus groups to direct the modification of infant formula manufacturer preparation instructions to enhance user understanding and accuracy. The modified instructions will be used in Phase 2.

Up to 150 individuals will be enrolled in Phase 2 to test the efficacy of the revised instructions on infant overfeeding in comparison with the instructions currently provided on the packaging.

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.

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

Primary outcomes:
measure: Focus Group Recommendations to Improve Infant Formula Preparation Instructions
timeFrame: Day 1
measure: Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Anne Gilmore, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: