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Clinical Trials/NCT05868811
NCT05868811
Completed
N/A

A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families

Children's Mercy Hospital Kansas City1 site in 1 country18 target enrollmentJanuary 16, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity, Infant
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
18
Locations
1
Primary Endpoint
Relative Reinforcing Value of Food (RRV) Task
Status
Completed
Last Updated
7 months ago

Overview

Brief Summary

The goal of this clinical trial is to learn about the effects of a music enrichment program on the quality of parent child interactions, a child's motivation to eat, and a child's language environment in 9 to 24 month-old children from low-income families. The main questions it aims to answer are:

  1. Does participation in a music enrichment program improve the quality of parent-child interactions?
  2. Does participation in a music enrichment program reduce motivation for food
  3. Does participation in a music enrichment program improve the quality of the language environment?

Participants will:

  1. Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.

  2. At the beginning, after the first 8 weeks and after the second 8 weeks, a researcher will come to the participants house and parent-child pairs will:

    1. be video recorded during 10 minutes of playtime and meal time.
    2. fill out questionnaires
    3. wear a small wearable language recorder for 16 hours
  3. At the beginning, after the first 8 weeks and after the second 8 weeks, the parent and child will come to the baby lab and will:

    1. Play a computer game to test motivation for food
    2. have height and weight measurements collected

Researchers will compare the music and play groups to see if there is a difference in the quality of parent child interaction, food motivation or language environment.

Registry
clinicaltrials.gov
Start Date
January 16, 2023
End Date
February 13, 2024
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City
Responsible Party
Principal Investigator
Principal Investigator

Kai Ling Kong

Doctoral Research Faculty, PhD

Children's Mercy Hospital Kansas City

Eligibility Criteria

Inclusion Criteria

  • Family income meets criteria for the National Women, Infant, and Children (WIC) program
  • Family is able and willing to commit to a 6-month program

Exclusion Criteria

  • Mother \<18 years old at the time of delivery
  • During pregnancy:
  • Mother smoked \>10 cigarettes/day
  • Mother used \>1 marijuana joint/day
  • Mother used any other illicit drugs
  • Mother drank \> 3 standard drinks on a single occasion or \>1 standard drink on a daily basis
  • Preterm birth \<37 weeks gestation
  • Child with significant health issues, and/or genetic conditions (e.g., cerebral palsy, down's syndrome)
  • Mother with major health concerns during pregnancy (e.g., gestational diabetes, pre-eclampsia, etc)
  • Parent/child who do not speak English

Outcomes

Primary Outcomes

Relative Reinforcing Value of Food (RRV) Task

Time Frame: Baseline, Mid (8 weeks), Post (16 weeks)

RRVfood is a proximal measure of obesity risk. It measures how motivated one is to work to gain access to food versus non-food activity. RRVfood is the score for food divided by the total score (food + music). Scale range is 0-1. Lower number is the better outcome. The score for food is determined by a computer game to test motivation for food. The score for music is determined by a computer game to test motivation for music.

Use of Music at Home

Time Frame: Baseline and Post (16 weeks)

The Music @ Home Questionnaire was used to quantitatively assess the range of musical behaviors occurring in the home environment of families with young children. Participant score is based on a questionnaire with 18 questions each with a range of 1-7. Total score range of the questionnaire is 7- 126. The higher outcome is better.

Conversational Turns

Time Frame: Baseline, Mid (8 weeks), Post (16 weeks)

Back-and-forth vocalizations between a parent and child, even with pre-linguistic children, are considered a pivotal component of a high-quality early language environment because they associate with growth in specific brain regions responsible for language and cognitive development.

Study Sites (1)

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