Infant Development, Motivation
Conditions
Brief 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.
Detailed description
Obesity is a disorder of positive energy balance in which energy intake exceeds energy expenditure. The motivation to eat is a basic human need, which is present at birth. One factor that may lead to increased energy intake is the imbalance between the motivation to eat and the motivation to engage in other behaviors. The motivation to eat versus engaging in other behaviors can be operationalized as the relative reinforcing value of eating versus alternative behaviors. A strong motivation to eat instead of engaging in alternative behaviors has been related to increased energy intake in adults. The motivation to eat is cross-sectionally and prospectively related to obesity in children, adolescents, and adults, and cross-sectionally related to weight status in infants. Shifting the balance from high motivation to eat to increased motivation to engage in alternative behaviors can reduce energy intake, and may be protective against weight gain. A structured program to enhance music engagement in infants who are strongly motivated to eat can shift their choice from food to music. This study will expand on this preliminary research and examine long-term effects of this intervention in infants who are highly motivated to eat.
Interventions
BEHAVIORALMusic Enhancement
BEHAVIORALPlay Date
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 15 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Infant Food Reinforcing Proportion | 0-, 3-, 6-, 12-, 24- month | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant 24-Hour Dietary Recall- Change in Energy Intake | 0-, 12-, 24- month | Energy intake was measured using a 24-recall with the parent and average kcals are reported. One participant was excluded for underreporting |
| Change in Infant Weight-for-length Z-score | 0-, 3-, 6-, 12-, 24- month | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Music Enhancement 37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Music Enhancement | 45 |
| Play Date 37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 8 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Music Enhancement | Play Date | Total |
|---|---|---|---|
| Age, Continuous | 12.1 months STANDARD_DEVIATION 1.7 | 11.9 months STANDARD_DEVIATION 2.1 | 12.0 months STANDARD_DEVIATION 1.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 45 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Household income, categorical <$50,000/year | 7 Participants | 9 Participants | 16 Participants |
| Household income, categorical >=$50,000/year | 35 Participants | 35 Participants | 70 Participants |
| Household income, categorical No Response | 3 Participants | 1 Participants | 4 Participants |
| Mother Age | 31.6 years STANDARD_DEVIATION 3.9 | 33.2 years STANDARD_DEVIATION 4.1 | 32.4 years STANDARD_DEVIATION 4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 4 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 35 Participants | 39 Participants | 72 Participants |
| Region of Enrollment United States | 45 participants | 45 participants | 90 participants |
| Sex: Female, Male Female | 45 Participants | 23 Participants | 90 Participants |
| Sex: Female, Male Male | 21 Participants | 22 Participants | 43 Participants |
| Weight-for-length z-score | -0.96 z-score STANDARD_DEVIATION 1.63 | -0.55 z-score STANDARD_DEVIATION 1.72 | -0.755 z-score STANDARD_DEVIATION 1.68 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 45 |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
Change in Infant Food Reinforcing Proportion
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
Time frame: 0-, 3-, 6-, 12-, 24- month
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Enhancement | Change in Infant Food Reinforcing Proportion | 3-month food reinforcing proportion | 0.53 proportion food response/total response | Standard Deviation 0.2 |
| Music Enhancement | Change in Infant Food Reinforcing Proportion | 12-month food reinforcing proportion | 0.44 proportion food response/total response | Standard Deviation 0.22 |
| Music Enhancement | Change in Infant Food Reinforcing Proportion | 6-month food reinforcing proportion | 0.48 proportion food response/total response | Standard Deviation 0.2 |
| Music Enhancement | Change in Infant Food Reinforcing Proportion | 24-month food reinforcing proportion | 0.47 proportion food response/total response | Standard Deviation 0.22 |
| Music Enhancement | Change in Infant Food Reinforcing Proportion | Baseline food reinforcing proportion | 0.66 proportion food response/total response | Standard Deviation 0.19 |
| Play Date | Change in Infant Food Reinforcing Proportion | 24-month food reinforcing proportion | 0.50 proportion food response/total response | Standard Deviation 0.22 |
| Play Date | Change in Infant Food Reinforcing Proportion | Baseline food reinforcing proportion | 0.64 proportion food response/total response | Standard Deviation 0.19 |
| Play Date | Change in Infant Food Reinforcing Proportion | 3-month food reinforcing proportion | 0.54 proportion food response/total response | Standard Deviation 0.22 |
| Play Date | Change in Infant Food Reinforcing Proportion | 6-month food reinforcing proportion | 0.58 proportion food response/total response | Standard Deviation 0.23 |
| Play Date | Change in Infant Food Reinforcing Proportion | 12-month food reinforcing proportion | 0.63 proportion food response/total response | Standard Deviation 0.23 |
p-value: 0.016Mixed Models Analysis
Secondary
Change in Infant Weight-for-length Z-score
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
Time frame: 0-, 3-, 6-, 12-, 24- month
Population: Intent to treat
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Enhancement | Change in Infant Weight-for-length Z-score | 3-month child z-weight-for-length | 0.5566 standardized z-score | Standard Deviation 0.6929 |
| Music Enhancement | Change in Infant Weight-for-length Z-score | 12-month child z-weight-for-length | 0.6554 standardized z-score | Standard Deviation 0.705 |
| Music Enhancement | Change in Infant Weight-for-length Z-score | 6-month child z-weight-for-length | 0.6650 standardized z-score | Standard Deviation 0.7023 |
| Music Enhancement | Change in Infant Weight-for-length Z-score | 24-month child z-weight-for-length | 0.8271 standardized z-score | Standard Deviation 0.7366 |
| Music Enhancement | Change in Infant Weight-for-length Z-score | Baseline child z-weight-for-length | 0.5825 standardized z-score | Standard Deviation 0.6775 |
| Play Date | Change in Infant Weight-for-length Z-score | 24-month child z-weight-for-length | 0.7275 standardized z-score | Standard Deviation 0.7452 |
| Play Date | Change in Infant Weight-for-length Z-score | Baseline child z-weight-for-length | 0.5646 standardized z-score | Standard Deviation 0.6977 |
| Play Date | Change in Infant Weight-for-length Z-score | 3-month child z-weight-for-length | 0.5417 standardized z-score | Standard Deviation 0.7345 |
| Play Date | Change in Infant Weight-for-length Z-score | 6-month child z-weight-for-length | 0.5681 standardized z-score | Standard Deviation 0.7681 |
| Play Date | Change in Infant Weight-for-length Z-score | 12-month child z-weight-for-length | 0.7444 standardized z-score | Standard Deviation 0.7896 |
Comparison: mixed-effect regression analysis with covariates: child sex, birth weight, breastfeeding duration, percent class attendance and covid categoriesp-value: 0.54Mixed Models Analysis
Secondary
Infant 24-Hour Dietary Recall- Change in Energy Intake
Energy intake was measured using a 24-recall with the parent and average kcals are reported. One participant was excluded for underreporting
Time frame: 0-, 12-, 24- month
Population: one participant excluded for underreporting
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Music Enhancement | Infant 24-Hour Dietary Recall- Change in Energy Intake | Baseline child average kcal | 914.2 kilocalories | Standard Error 33.5 |
| Music Enhancement | Infant 24-Hour Dietary Recall- Change in Energy Intake | 12-month child average kcal | 1163.5 kilocalories | Standard Error 46.7 |
| Music Enhancement | Infant 24-Hour Dietary Recall- Change in Energy Intake | 24-month child average kcal | 1247.8 kilocalories | Standard Error 42.9 |
| Play Date | Infant 24-Hour Dietary Recall- Change in Energy Intake | Baseline child average kcal | 898.2 kilocalories | Standard Error 33.8 |
| Play Date | Infant 24-Hour Dietary Recall- Change in Energy Intake | 12-month child average kcal | 1092.2 kilocalories | Standard Error 52.1 |
| Play Date | Infant 24-Hour Dietary Recall- Change in Energy Intake | 24-month child average kcal | 1201.9 kilocalories | Standard Error 43.9 |
Comparison: mixed effect regression analysis, unstructured covariance, no covariates. Reporting group x time interactionp-value: 0.7Mixed Models Analysis