Trial Outcomes & Findings for Music and Child Health and Development (NCT NCT05868811)
NCT ID: NCT05868811
Last Updated: 2025-09-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Baseline, Mid (8 weeks), Post (16 weeks)
Results posted on
2025-09-23
Participant Flow
The Protocol Enrollment represents the total number of dyads enrolled.
4 participants dropped out after enrollment before group assignment.
Participant milestones
| Measure |
Music Together-child
Music Together-child: 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 Group-child
Play Group-child: 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.
|
Music Together- Parent
Music Together-parent: 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 Group- Parent
Play Group-parent: 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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
8
|
8
|
|
Overall Study
COMPLETED
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Parents were not assessed for this Baseline Measure.
Baseline characteristics by cohort
| Measure |
Music Together-child
n=8 Participants
Music Together-child: 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 Group-child
n=8 Participants
Play Group-child: 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.
|
Music Together-parent
n=8 Participants
Music Together-parent: 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 Group-parent
n=8 Participants
Play Group-parent: 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.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
1.32 years
STANDARD_DEVIATION 0.40 • n=8 Participants
|
1.43 years
STANDARD_DEVIATION 0.39 • n=8 Participants
|
30.43 years
STANDARD_DEVIATION 5.02 • n=8 Participants
|
33.25 years
STANDARD_DEVIATION 5.06 • n=8 Participants
|
16.61 years
STANDARD_DEVIATION 2.72 • n=32 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
24 Participants
n=32 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=32 Participants
|
|
Age, Categorical
<=18 years
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
16 Participants
n=32 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
16 Participants
n=32 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
30 Participants
n=32 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
19 Participants
n=32 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
8 Participants
n=32 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
5 Participants
n=32 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=32 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
8 participants
n=8 Participants
|
16 participants
n=32 Participants
|
|
Relative reinforcing value of food (RRVfood)
|
0.50 units on a scale
STANDARD_DEVIATION 0.06 • n=8 Participants • Parents were not assessed for this Baseline Measure.
|
0.40 units on a scale
STANDARD_DEVIATION 0.06 • n=8 Participants • Parents were not assessed for this Baseline Measure.
|
—
|
—
|
0.45 units on a scale
STANDARD_DEVIATION 0.06 • n=16 Participants • Parents were not assessed for this Baseline Measure.
|
|
Conversational turns
|
280.19 count
STANDARD_DEVIATION 69.99 • n=8 Participants • Parents were not assessed for this Baseline Measure.
|
216.07 count
STANDARD_DEVIATION 74.82 • n=8 Participants • Parents were not assessed for this Baseline Measure.
|
—
|
—
|
248.13 count
STANDARD_DEVIATION 72.41 • n=16 Participants • Parents were not assessed for this Baseline Measure.
|
|
Use of music at home
|
94.87 units on a scale
STANDARD_DEVIATION 7.25 • n=8 Participants • Parents were not assessed for this Baseline Measure.
|
98.83 units on a scale
STANDARD_DEVIATION 8.26 • n=8 Participants • Parents were not assessed for this Baseline Measure.
|
—
|
—
|
96.85 units on a scale
STANDARD_DEVIATION 7.76 • n=16 Participants • Parents were not assessed for this Baseline Measure.
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Together Baseline
n=8 Participants
Music Together: 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 Group Baseline
n=8 Participants
Play Group: 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.
|
Music Together Mid
n=8 Participants
Music Together: 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 Group Mid
n=8 Participants
Play Group: 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.
|
Music Together Post
n=8 Participants
Music Together: 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 Group Post
n=8 Participants
Play Group: 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.
|
|---|---|---|---|---|---|---|
|
Relative Reinforcing Value of Food (RRV) Task
|
0.48 units on a scale
Standard Error 0.08
|
0.35 units on a scale
Standard Error 0.08
|
0.5 units on a scale
Standard Error 0.07
|
0.4 units on a scale
Standard Error 0.07
|
0.53 units on a scale
Standard Error 0.08
|
0.62 units on a scale
Standard Error 0.08
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Together Baseline
n=8 Participants
Music Together: 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 Group Baseline
n=8 Participants
Play Group: 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.
|
Music Together Mid
n=8 Participants
Music Together: 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 Group Mid
n=8 Participants
Play Group: 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.
|
Music Together Post
Music Together: 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 Group Post
Play Group: 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.
|
|---|---|---|---|---|---|---|
|
Use of Music at Home
|
95 units on a scale
Standard Error 14
|
100.5 units on a scale
Standard Error 12.13
|
106.33 units on a scale
Standard Error 11.33
|
98.25 units on a scale
Standard Error 9.81
|
—
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Together Baseline
n=8 Participants
Music Together: 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 Group Baseline
n=8 Participants
Play Group: 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.
|
Music Together Mid
n=8 Participants
Music Together: 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 Group Mid
n=8 Participants
Play Group: 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.
|
Music Together Post
n=8 Participants
Music Together: 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 Group Post
n=8 Participants
Play Group: 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.
|
|---|---|---|---|---|---|---|
|
Conversational Turns
|
8392.67 count
Standard Error 1625.78
|
13535.00 count
Standard Error 1407.96
|
6116.33 count
Standard Error 1867.00
|
13410.88 count
Standard Error 1616.87
|
9974.50 count
Standard Error 4227.72
|
10913.88 count
Standard Error 3661.32
|
Adverse Events
Music Together
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Play Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place