Trial Outcomes & Findings for Infant Environment Study (NCT NCT02936284)
NCT ID: NCT02936284
Last Updated: 2024-09-04
Results Overview
Food reinforcing proportion measures responding for food / total responding for both food and music as a proportion score. Scores range from 0 to 1.0 and higher scores indicate more responding for food than for non-food alternative reinforcer of music. Means reported here are estimated from the mixed-model regression analysis
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
94 participants
Primary outcome timeframe
0-, 3-, 6-, 12-, 24- month
Results posted on
2024-09-04
Participant Flow
Participant milestones
| Measure |
Music Enhancement
37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Music Enhancement
|
Play Date
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
47
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
10
|
9
|
Reasons for withdrawal
| Measure |
Music Enhancement
37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Music Enhancement
|
Play Date
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
7
|
8
|
Baseline Characteristics
Infant Environment Study
Baseline characteristics by cohort
| Measure |
Music Enhancement
n=45 Participants
37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Music Enhancement
|
Play Date
n=45 Participants
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.1 months
STANDARD_DEVIATION 1.7 • n=5 Participants
|
11.9 months
STANDARD_DEVIATION 2.1 • n=7 Participants
|
12.0 months
STANDARD_DEVIATION 1.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Weight-for-length z-score
|
-0.96 z-score
STANDARD_DEVIATION 1.63 • n=5 Participants
|
-0.55 z-score
STANDARD_DEVIATION 1.72 • n=7 Participants
|
-0.755 z-score
STANDARD_DEVIATION 1.68 • n=5 Participants
|
|
Mother Age
|
31.6 years
STANDARD_DEVIATION 3.9 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Household income, categorical
<$50,000/year
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Household income, categorical
>=$50,000/year
|
35 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Household income, categorical
No Response
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-, 3-, 6-, 12-, 24- monthPopulation: Intent to treat analysis
Food reinforcing proportion measures responding for food / total responding for both food and music as a proportion score. Scores range from 0 to 1.0 and higher scores indicate more responding for food than for non-food alternative reinforcer of music. Means reported here are estimated from the mixed-model regression analysis
Outcome measures
| Measure |
Music Enhancement
n=45 Participants
37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Music Enhancement
|
Play Date
n=45 Participants
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date
|
|---|---|---|
|
Change in Infant Food Reinforcing Proportion
Baseline food reinforcing proportion
|
0.66 proportion food response/total response
Standard Deviation 0.19
|
0.64 proportion food response/total response
Standard Deviation 0.19
|
|
Change in Infant Food Reinforcing Proportion
3-month food reinforcing proportion
|
0.53 proportion food response/total response
Standard Deviation 0.20
|
0.54 proportion food response/total response
Standard Deviation 0.22
|
|
Change in Infant Food Reinforcing Proportion
6-month food reinforcing proportion
|
0.48 proportion food response/total response
Standard Deviation 0.20
|
0.58 proportion food response/total response
Standard Deviation 0.23
|
|
Change in Infant Food Reinforcing Proportion
12-month food reinforcing proportion
|
0.44 proportion food response/total response
Standard Deviation 0.22
|
0.63 proportion food response/total response
Standard Deviation 0.23
|
|
Change in Infant Food Reinforcing Proportion
24-month food reinforcing proportion
|
0.47 proportion food response/total response
Standard Deviation 0.22
|
0.50 proportion food response/total response
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: 0-, 12-, 24- monthPopulation: one participant excluded for underreporting
Energy intake was measured using a 24-recall with the parent and average kcals are reported. One participant was excluded for underreporting
Outcome measures
| Measure |
Music Enhancement
n=44 Participants
37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Music Enhancement
|
Play Date
n=45 Participants
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date
|
|---|---|---|
|
Infant 24-Hour Dietary Recall- Change in Energy Intake
Baseline child average kcal
|
914.2 kilocalories
Standard Error 33.5
|
898.2 kilocalories
Standard Error 33.8
|
|
Infant 24-Hour Dietary Recall- Change in Energy Intake
12-month child average kcal
|
1163.5 kilocalories
Standard Error 46.7
|
1092.2 kilocalories
Standard Error 52.1
|
|
Infant 24-Hour Dietary Recall- Change in Energy Intake
24-month child average kcal
|
1247.8 kilocalories
Standard Error 42.9
|
1201.9 kilocalories
Standard Error 43.9
|
SECONDARY outcome
Timeframe: 0-, 3-, 6-, 12-, 24- monthPopulation: Intent to treat
Weight for length is a measure of an infant (child under 5-years of age) height (cm) and weight (kg) scored using the World Health Organization (WHO) infant growth chart. Overweight cut-offs at a z-score between 1.0-1.99 and obese cut offs are at a z-score of \>=2.0
Outcome measures
| Measure |
Music Enhancement
n=45 Participants
37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Music Enhancement
|
Play Date
n=45 Participants
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date
|
|---|---|---|
|
Change in Infant Weight-for-length Z-score
Baseline child z-weight-for-length
|
0.5825 standardized z-score
Standard Deviation 0.6775
|
0.5646 standardized z-score
Standard Deviation 0.6977
|
|
Change in Infant Weight-for-length Z-score
3-month child z-weight-for-length
|
0.5566 standardized z-score
Standard Deviation 0.6929
|
0.5417 standardized z-score
Standard Deviation 0.7345
|
|
Change in Infant Weight-for-length Z-score
6-month child z-weight-for-length
|
0.6650 standardized z-score
Standard Deviation 0.7023
|
0.5681 standardized z-score
Standard Deviation 0.7681
|
|
Change in Infant Weight-for-length Z-score
12-month child z-weight-for-length
|
0.6554 standardized z-score
Standard Deviation 0.7050
|
0.7444 standardized z-score
Standard Deviation 0.7896
|
|
Change in Infant Weight-for-length Z-score
24-month child z-weight-for-length
|
0.8271 standardized z-score
Standard Deviation 0.7366
|
0.7275 standardized z-score
Standard Deviation 0.7452
|
Adverse Events
Music Enhancement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Play Date
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kai Ling Kong, PhD
Children's Mercy Hospital, Kansas University
Phone: 816-731-7239
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place