Infant Environment Study

Enhancing Alternatives to Eating in Infancy

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.

Study Overview

• Status: Completed
• Conditions: Motivation; Infant Development
• Intervention / Treatment: Behavioral: Music Enhancement; Behavioral: Play Date

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • University at Buffalo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Infant Food Reinforcing Proportion	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	0-, 3-, 6-, 12-, 24- month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant 24-Hour Dietary Recall- Change in Energy Intake	Energy intake was measured using a 24-recall with the parent and average kcals are reported. One participant was excluded for underreporting	0-, 12-, 24- month
Change in Infant Weight-for-length Z-score	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	0-, 3-, 6-, 12-, 24- month

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Leonard Epstein, Ph.D, University at Buffalo

Publications and helpful links

General Publications

• Kong KL, Eiden RD, Morris KS, Paluch RA, Carr KA, Epstein LH. Reducing relative food reinforcement of infants using a music enrichment program: a randomized, controlled trial. Am J Clin Nutr. 2022 Dec 19;116(6):1642-1653. doi: 10.1093/ajcn/nqac209.
• Kong KL, Shisler S, Eiden RD, Anzman-Frasca S, Piazza J. Examining the Relationship between Infant Weight Status and Parent-Infant Interactions within a Food and Nonfood Context. Child Obes. 2022 Sep;18(6):422-432. doi: 10.1089/chi.2021.0126. Epub 2022 Jan 12.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimated): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1134699-1-75860; 1R01HD087082-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared upon request to PI