- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02936284
Infant Environment Study
Enhancing Alternatives to Eating in Infancy
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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Buffalo, New York, United States, 14214
- University at Buffalo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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Active Comparator: Play Date
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Infant Food Reinforcing Ratio
Time Frame: 0-, 3-, 6-, 12-, 24- month
|
Infants will potentially change their FRR based on the randomized class
|
0-, 3-, 6-, 12-, 24- month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infant 24-Hour Dietary Recall- Change in Energy Intake
Time Frame: 0-, 3-, 6-, 12-, 24- month
|
Infants will potentially have a change in their energy intake as they age in randomized classes
|
0-, 3-, 6-, 12-, 24- month
|
Change in Infant z weight-for-length
Time Frame: 0-, 3-, 6-, 12-, 24- month
|
Infants will potentially change with z wfl based on the randomized class
|
0-, 3-, 6-, 12-, 24- month
|
Change in Home Enrichment Score
Time Frame: 0-, 6-, 12-, 24- month
|
Infant's home score will potentially change based on the randomized class
|
0-, 6-, 12-, 24- month
|
Collaborators and Investigators
Collaborators
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
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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