MedPath

Infant Environment Study

Not Applicable
Completed
Conditions
Infant Development
Motivation
Interventions
Behavioral: Play Date
Behavioral: Music Enhancement
Registration Number
NCT02936284
Lead Sponsor
State University of New York at Buffalo
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
94
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Play DatePlay Date37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Music EnhancementMusic Enhancement37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Primary Outcome Measures
NameTimeMethod
Change in Infant Food Reinforcing Proportion0-, 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 Outcome Measures
NameTimeMethod
Infant 24-Hour Dietary Recall- Change in Energy Intake0-, 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-score0-, 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

Trial Locations

Locations (1)

University at Buffalo

🇺🇸

Buffalo, New York, United States

© Copyright 2025. All Rights Reserved by MedPath