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Infant Environment Study

University at Buffalo (UB) logo

University at Buffalo (UB)

Status

Completed

Conditions

Motivation
Infant Development

Treatments

Behavioral: Play Date
Behavioral: Music Enhancement

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02936284
1R01HD087082-01A1 (U.S. NIH Grant/Contract)
1134699-1-75860

Details and patient eligibility

About

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.

Full 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.

Enrollment

94 patients

Sex

All

Ages

9 to 15 months old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

94 participants in 2 patient groups

Music Enhancement
Experimental group
Description:
37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.
Treatment:
Behavioral: Music Enhancement
Play Date
Active Comparator group
Description:
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Treatment:
Behavioral: Play Date

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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