N/A
Completed N=94
Infant Environment Study
Infant Development · Motivation
Source: ClinicalTrials.gov NCT02936284 ↗
Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcomePrimary: Change in Infant Food Reinforcing Proportion — 0.66; 0.64; 0.53; 0.54 proportion food response/total response — p=0.016
Summary
This study evaluates the effect of a music enhancement program to strengthen the motivation to engage in music related behaviors rather than eating in infants who are high in motivation to eat. Half the participants will participate in a Music Together Program, while the other half will participate in a Play Date control. For both groups, participants will attend 34 weekly sessions for one year, and 12 monthly sessions the next year, in 6 cohorts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Infant Food Reinforcing Proportion |
0.66; 0.64; 0.53; 0.54; 0.48; 0.58 | 0.016 sig |
| SECONDARY Infant 24-Hour Dietary Recall- Change in Energy Intake |
914.2; 898.2; 1163.5; 1092.2; 1247.8; 1201.9 | 0.70 |
| SECONDARY Change in Infant Weight-for-length Z-score |
0.5825; 0.5646; 0.5566; 0.5417; 0.6650; 0.5681 | 0.540 |
Eligibility Criteria
Inclusion Criteria
- High food reinforcement
Exclusion Criteria
- born preterm (<37 weeks gestation)
- a low birth weight (< 2500 grams)
- known developmental delay(s)
- subject's mother was < 18 years old at the time of pregnancy
- not yet eating finger foods
Data sourced from ClinicalTrials.gov (NCT02936284). 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. Informational only — not medical advice.