Childhood Obesity, Infant Development
Conditions
Keywords
Infant Formula
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.
Interventions
None listed
Sponsors
Pennington Biomedical Research Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Focus Group Recommendations to Improve Infant Formula Preparation Instructions | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 21 |
| Phase 2 Standard Instructions Up to 75 individuals who did not participate in Whoa Baby Phase 1 were recruited to prepare bottles using the standard infant formula preparation instructions. | 75 |
| Phase 2 Modified Instructions Up to 75 individuals who did not participate in Whoa Baby Phase 1 were recruited to prepare bottles using the modified infant formula preparation instructions. The modified instructions were developed as a result of the focus groups' conditions in Phase 1. | 75 |
| Total | 171 |
Baseline characteristics
| Characteristic | Phase 2 Modified Instructions | Total | Phase 2 Standard Instructions | Phase 1 |
|---|---|---|---|---|
| Age, Continuous | 40.6 years STANDARD_DEVIATION 17.6 | 37.8 years STANDARD_DEVIATION 16.5 | 36.0 years STANDARD_DEVIATION 15.8 | 32.5 years STANDARD_DEVIATION 11.7 |
| BMI, Continuous | 29.5 kg/m^2 STANDARD_DEVIATION 7.9 | 29.2 kg/m^2 STANDARD_DEVIATION 7.5 | 29.6 kg/m^2 STANDARD_DEVIATION 6.6 | 26.8 kg/m^2 STANDARD_DEVIATION 8.1 |
| Education, Categorical 1-3 Years College | 37 Participants | 68 Participants | 26 Participants | 5 Participants |
| Education, Categorical College Degree | 17 Participants | 51 Participants | 25 Participants | 9 Participants |
| Education, Categorical High School Diploma/GED or Less | 5 Participants | 14 Participants | 8 Participants | 1 Participants |
| Education, Categorical Post-Graduate Degree | 16 Participants | 38 Participants | 16 Participants | 6 Participants |
| Income, Categorical $30,000-$99,999/year | 28 Participants | 69 Participants | 32 Participants | 9 Participants |
| Income, Categorical <$30,000/year | 21 Participants | 47 Participants | 21 Participants | 5 Participants |
| Income, Categorical >$80,000/year | 25 Participants | 53 Participants | 21 Participants | 7 Participants |
| Income, Categorical No answer | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 7 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 46 Participants | 25 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 54 Participants | 115 Participants | 46 Participants | 15 Participants |
| Sex: Female, Male Female | 59 Participants | 141 Participants | 65 Participants | 17 Participants |
| Sex: Female, Male Male | 16 Participants | 30 Participants | 10 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 75 | 0 / 75 |
| other Total, other adverse events | 0 / 21 | 0 / 75 | 0 / 75 |
| serious Total, serious adverse events | 0 / 21 | 0 / 75 | 0 / 75 |
Outcome results
Primary
Focus Group Recommendations to Improve Infant Formula Preparation Instructions
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.
Time frame: Day 1
Population: The focus groups were only completed for Phase 1 participants. This outcome measure does not apply to Phase 2 participants who did not participate in focus groups and provide infant formula preparation instructions.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1 | Focus Group Recommendations to Improve Infant Formula Preparation Instructions | Move mixing guide to the top | 60 percentage of focus group participants |
| Phase 1 | Focus Group Recommendations to Improve Infant Formula Preparation Instructions | Pictures were helpful | 60 percentage of focus group participants |
| Phase 1 | Focus Group Recommendations to Improve Infant Formula Preparation Instructions | Clarify Safety Information | 80 percentage of focus group participants |
| Phase 1 | Focus Group Recommendations to Improve Infant Formula Preparation Instructions | Define and emphasize level and unpacked scoop | 100 percentage of focus group participants |
Primary
Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight
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.
Time frame: Day 1
Population: This outcome measure does not apply to Phase 1 participants because Phase 1 participants did not participate in the double blind, randomized controlled portion of the trial. Phase 1 participants did not prepare infant formula bottles according to either the standard or modified instructions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 2 | Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight | -4.66 percentage of error | Standard Deviation 0.74 |
| Phase 2 Modified Instructions | Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight | -0.67 percentage of error | Standard Deviation 0.76 |