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Completed

NCT Number: NCT02936284

Infant Environment Study

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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Key information

Conditions

Infant Development Motivation

Age range

9 month–15 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo

Buffalo, New York, 14214, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Enhancement

Behavioral

Play Date

Behavioral

Primary outcomes

  1. Change in Infant Food Reinforcing Proportion

    Time frame: 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 outcomes

  1. Infant 24-Hour Dietary Recall- Change in Energy Intake

    Time frame: 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

  2. Change in Infant Weight-for-length Z-score

    Time frame: 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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Official study title

Enhancing Alternatives to Eating in Infancy

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 18, 2016
Registry last updated
Sep 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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