Trial Outcomes & Findings for Unintentional Overfeeding of Formula Fed Infants (NCT NCT02701868)
NCT ID: NCT02701868
Last Updated: 2021-01-14
Results Overview
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.
COMPLETED
171 participants
Day 1
2021-01-14
Participant Flow
Participant milestones
| Measure |
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 Research Center Demonstration Kitchen over the course of approximately 3 months.
|
Phase 2 Standard Instructions
Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using standard instructions.
|
Phase 2 Modified Instructions
Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
75
|
75
|
|
Overall Study
COMPLETED
|
21
|
75
|
75
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Unintentional Overfeeding of Formula Fed Infants
Baseline characteristics by cohort
| Measure |
Phase 1
n=21 Participants
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.
|
Phase 2 Standard Instructions
n=75 Participants
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.
|
Phase 2 Modified Instructions
n=75 Participants
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.
|
Total
n=171 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
32.5 years
STANDARD_DEVIATION 11.7 • n=93 Participants
|
36.0 years
STANDARD_DEVIATION 15.8 • n=4 Participants
|
40.6 years
STANDARD_DEVIATION 17.6 • n=27 Participants
|
37.8 years
STANDARD_DEVIATION 16.5 • n=483 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
59 Participants
n=27 Participants
|
141 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
46 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
115 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
BMI, Continuous
|
26.8 kg/m^2
STANDARD_DEVIATION 8.1 • n=93 Participants
|
29.6 kg/m^2
STANDARD_DEVIATION 6.6 • n=4 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 7.9 • n=27 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 7.5 • n=483 Participants
|
|
Education, Categorical
High School Diploma/GED or Less
|
1 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Education, Categorical
1-3 Years College
|
5 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
|
Education, Categorical
College Degree
|
9 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
51 Participants
n=483 Participants
|
|
Education, Categorical
Post-Graduate Degree
|
6 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Income, Categorical
<$30,000/year
|
5 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
47 Participants
n=483 Participants
|
|
Income, Categorical
$30,000-$99,999/year
|
9 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
69 Participants
n=483 Participants
|
|
Income, Categorical
>$80,000/year
|
7 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
|
Income, Categorical
No answer
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Phase 1
n=21 Participants
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.
|
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.
|
Phase 2 Modified Instructions
Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.
|
|---|---|---|---|
|
Focus Group Recommendations to Improve Infant Formula Preparation Instructions
Pictures were helpful
|
60 percentage of focus group participants
|
—
|
—
|
|
Focus Group Recommendations to Improve Infant Formula Preparation Instructions
Clarify Safety Information
|
80 percentage of focus group participants
|
—
|
—
|
|
Focus Group Recommendations to Improve Infant Formula Preparation Instructions
Define and emphasize "level" and "unpacked" scoop
|
100 percentage of focus group participants
|
—
|
—
|
|
Focus Group Recommendations to Improve Infant Formula Preparation Instructions
Move mixing guide to the top
|
60 percentage of focus group participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
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.
|
Phase 2
n=75 Participants
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.
|
Phase 2 Modified Instructions
n=75 Participants
Up to 150 individuals who did not participate in Whoa Baby Phase 1 will be recruited for Phase 2. Up to 75 individuals will be randomized to prepare infant formula using modified instructions.
|
|---|---|---|---|
|
Percent Error of Dispensed Formula Weight as Compared to Expected Formula Weight
|
—
|
-4.66 percentage of error
Standard Deviation 0.74
|
-0.67 percentage of error
Standard Deviation 0.76
|
Adverse Events
Phase 1
Phase 2 Standard Instructions
Phase 2 Modified Instructions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place