NCT02936284

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
14 days until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 4, 2024

Completed
Last Updated

September 4, 2024

Status Verified

August 1, 2024

Enrollment Period

4.7 years

First QC Date

August 19, 2016

Results QC Date

June 27, 2024

Last Update Submit

August 8, 2024

Conditions

Infant DevelopmentMotivation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Infant 24-Hour Dietary Recall- Change in Energy Intake

    0-, 12-, 24- month

  • Change in Infant Weight-for-length Z-score

    0-, 3-, 6-, 12-, 24- month

Study Arms (2)

Music Enhancement

EXPERIMENTAL

37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year.

Behavioral: Music Enhancement

Play Date

ACTIVE COMPARATOR

37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.

Behavioral: Play Date

Interventions

Music EnhancementBEHAVIORAL
Music Enhancement
Play DateBEHAVIORAL
Play Date

Eligibility Criteria

Age9 Months - 15 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • High food reinforcement

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

Related Publications (3)

  • Smith AR, McGregor CM, Carr K, Epstein LH, Serwatka C, Paluch R, Piazza J, Shisler S, Kong KL. The impact of a music enrichment program during infancy and early toddlerhood on effortful control at age 3: A preliminary investigation. Infancy. 2024 Jan-Feb;29(1):72-79. doi: 10.1111/infa.12563. Epub 2023 Oct 12.

    PMID: 37823562DERIVED

  • 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.

    PMID: 36250608DERIVED

  • 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.

    PMID: 35021890DERIVED

Results Point of Contact

Title
Kai Ling Kong, PhD
Organization
Children's Mercy Hospital, Kansas University
kkong@cmh.edu
816-731-7239

Study Officials

  • Leonard Epstein, Ph.D

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 19, 2016

First Posted

October 18, 2016

Study Start

November 1, 2016

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

September 4, 2024

Results First Posted

September 4, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Data will be shared upon request to PI

Locations

US(1)