Infant Environment Study

Infant Development Clinical Trial

Official title:

Enhancing Alternatives to Eating in Infancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02936284
• Other study ID #: 1134699-1-75860
• Secondary ID: 1R01HD087082-01A
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: July 2021

Study information

• Verified date: March 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: July 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Months to 15 Months

Eligibility

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

Related Conditions & MeSH terms

• Infant Development
• Motivation

Intervention

Behavioral:
• Music Enhancement

• Play Date

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
State University of New York at Buffalo	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Infant Food Reinforcing Ratio	Infants will potentially change their FRR based on the randomized class	0-, 3-, 6-, 12-, 24- month
Secondary	Infant 24-Hour Dietary Recall- Change in Energy Intake	Infants will potentially have a change in their energy intake as they age in randomized classes	0-, 3-, 6-, 12-, 24- month
Secondary	Change in Infant z weight-for-length	Infants will potentially change with z wfl based on the randomized class	0-, 3-, 6-, 12-, 24- month
Secondary	Change in Home Enrichment Score	Infant's home score will potentially change based on the randomized class	0-, 6-, 12-, 24- month