N/A
N=171
Unintentional Overfeeding of Formula Fed Infants
Childhood Obesity · Infant Development
Bottom Line
View on ClinicalTrials.gov: NCT02701868 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Focus Group Recommendations to Improve Infant Formula Preparation Instructions — 60; 80; 100; 60 percentage of focus group participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pennington Biomedical Research Center
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Focus Group Recommendations to Improve Infant Formula Preparation Instructions |
60; 80; 100; 60 | — |
| PRIMARY Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight |
-4.66; -0.67 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02701868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.