Infant Environment Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2021-07-31

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.

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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.

Conditions

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Infant Development Motivation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Music Enhancement

37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.

Group Type EXPERIMENTAL

Music Enhancement

Intervention Type BEHAVIORAL

Play Date

37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.

Group Type ACTIVE_COMPARATOR

Play Date

Intervention Type BEHAVIORAL

Interventions

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Music Enhancement

Intervention Type BEHAVIORAL

Play Date

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

9 Months

Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes