Obesity, InfantNCT05868811
Music and Child Health and Development
A study testing Music Together and Play Group in people with Obesity, Infant and Language Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Infant, Language Development, Parent-Child Relations
- What is being tested?
- Music Together and Play Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2023to 13 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families
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:
- Does participation in a music enrichment program improve the quality of parent-child interactions?
- Does participation in a music enrichment program reduce motivation for food
- Does participation in a music enrichment program improve the quality of the language environment?
Read more
Participants will:
- Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.
- 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:
- be video recorded during 10 minutes of playtime and meal time.
- fill out questionnaires
- wear a small wearable language recorder for 16 hours
- 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:
- Play a computer game to test motivation for food
- 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.
- Being tested
- Music Together, Play Group
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TogetherBehavioural
The intervention consists of 45-minute weekly classes for 16 weeks. Each class is delivered by a trained Music Together facilitator and includes music activities such as singing, dancing, moving and playing musical instruments. At the start of the program, participants receive materials for home use that consist of a song book and online access code for song recordings used in the class.
Play GroupBehavioural
The play group consists of 45-minute weekly classes for 16 weeks. During each class parents are encouraged to play with their child and interact with other participants using the provided age appropriate toys. At the start of the program participants receive an age appropriate toy for use at home.
| Study group | Role | What they receive |
|---|---|---|
| Music Together | Experimental | Not described Receives: Behavioral: Music Together |
| Play Group | Placebo comparator | Not described Receives: Behavioral: Play Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Reinforcing Value of Food (RRV) Task
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.
Measured: Baseline, Mid (8 weeks), Post (16 weeks)
Use of Music at Home
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.
Measured: Baseline and Post (16 weeks)
Conversational Turns
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.
Measured: Baseline, Mid (8 weeks), Post (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start16 Jan 2023
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity, InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kansas Medical Center, University of Kansas, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Kai Ling Kong, Children's Mercy Hospital Kansas City
- Investigators
- Kai Ling Kong, PhD, Principal investigator, Children's Mercy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868811
- Sponsor's protocol ID
- STUDY00002451
- Other IDs
- UL1TR002366
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2023
- Last updated
- 23 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kong KL, Smith AR, Salley B, Hanson-Abromeit D, Engel H, Serwatka CA. A Feasibility Study of a Music Enrichment Program on Relative Reinforcing Value of Food and Home Environmental Enrichment among Families of Low Socioeconomic Status. Children (Basel). 2024 Oct 11;11(10):1229. doi: 10.3390/children11101229.
PubMed 39457194
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Music and Play to Enhance Health and Developmental Outcomes in Infants From Low-income Families
- ClinicalTrials.gov ID
- NCT05868811
- Acronym / sponsor ID
- STUDY00002451
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- University of Kansas Medical Center, University of Kansas, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 16 Jan 2023 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 22 May 2023 (actual)
- Results
- Posted 3 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does participation in a music enrichment program improve the quality of parent-child interactions?
- Does participation in a music enrichment program reduce motivation for food
- Does participation in a music enrichment program improve the quality of the language environment?
Participants will:
- Be randomly assigned to participate in either 2, 8-week semesters of weekly music enrichment classes or play group sessions.
- 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:
- be video recorded during 10 minutes of playtime and meal time.
- fill out questionnaires
- wear a small wearable language recorder for 16 hours
- 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:
- Play a computer game to test motivation for food
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Together | Experimental | Behavioral: Music Together |
| Play Group | Placebo comparator | Behavioral: Play Group |
Who may qualify
- Ages
- 9 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music TogetherThe intervention consists of 45-minute weekly classes for 16 weeks. Each class is delivered by a trained Music Together facilitator and includes music activities such as singing, dancing, moving and playing musical instruments. At the start of the program, participants receive materials for home use that consist of a song book and online access code for song recordings used in the class. | Behavioural | Music Together |
| Play GroupThe play group consists of 45-minute weekly classes for 16 weeks. During each class parents are encouraged to play with their child and interact with other participants using the provided age appropriate toys. At the start of the program participants receive an age appropriate toy for use at home. | Behavioural | Play Group |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39457194Kong KL, Smith AR, Salley B, Hanson-Abromeit D, Engel H, Serwatka CA. A Feasibility Study of a Music Enrichment Program on Relative Reinforcing Value of Food and Home Environmental Enrichment among Families of Low Socioeconomic Status. Children (Basel). 2024 Oct 11;11(10):1229. doi: 10.3390/children11101229.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai Ling Kong, PhD principal investigator
Children's Mercy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Together and Play Group in people with Obesity, Infant and Language Development, run by Children's Mercy Hospital Kansas City at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Reinforcing Value of Food (RRV) Task (time frame: Baseline, Mid (8 weeks), Post (16 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05868811, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.