Infant Environment Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Enhancing Alternatives to Eating in Infancy

Conditions
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Infant Development, Motivation

Intervention / Treatment
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* Behavioral: Music Enhancement
* Behavioral: Play Date


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 15 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Enhancement<br>37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year. | Behavioral: Music Enhancement<br> <br> |
| Active Comparator: Play Date<br>37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year. | Behavioral: Play Date<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Infant Food Reinforcing Ratio | Infants will potentially change their FRR based on the randomized class | 0-, 3-, 6-, 12-, 24- month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant 24-Hour Dietary Recall- Change in Energy Intake | Infants will potentially have a change in their energy intake as they age in randomized classes | 0-, 3-, 6-, 12-, 24- month | 
| Change in Infant z weight-for-length | Infants will potentially change with z wfl based on the randomized class | 0-, 3-, 6-, 12-, 24- month | 
| Change in Home Enrichment Score | Infant's home score will potentially change based on the randomized class | 0-, 6-, 12-, 24- month |