Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD087082-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Enhancement | Experimental | 37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year. |
|
| Play Date | Active Comparator | 37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music Enhancement | Behavioral |
| ||
| Play Date |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant 24-Hour Dietary Recall- Change in Energy Intake | Energy intake was measured using a 24-recall with the parent and average kcals are reported. One participant was excluded for underreporting | 0-, 12-, 24- month |
| Change in Infant Weight-for-length Z-score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leonard Epstein, Ph.D | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University at Buffalo | Buffalo | New York | 14214 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37823562 | Derived | 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. | |
| 36250608 | Derived | 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. |
Not provided
Not provided
Data will be shared upon request to PI
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Music Enhancement | 37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year. Music Enhancement |
| FG001 | Play Date | 37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year. Play Date |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Mother-infant dyads
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Music Enhancement | 37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year. Music Enhancement |
| BG001 | Play Date | 37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year. Play Date |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intent to treat analysis | Posted | Mean | Standard Deviation | proportion food response/total response | 0-, 3-, 6-, 12-, 24- month |
|
Baseline - two years
Adverse events were collected for the children only.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Music Enhancement | 37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year. Music Enhancement |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kai Ling Kong, PhD | Children's Mercy Hospital, Kansas University | 816-731-7239 | kkong@cmh.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2020 | Aug 8, 2024 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Weight for length is a measure of an infant (child under 5-years of age) height (cm) and weight (kg) scored using the World Health Organization (WHO) infant growth chart. Overweight cut-offs at a z-score between 1.0-1.99 and obese cut offs are at a z-score of >=2.0 |
| 0-, 3-, 6-, 12-, 24- month |
| 35021890 | Derived | 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. |
| BG002 | Total | Total of all reporting groups |
| months |
|
| Sex: Female, Male | Infant sex | Count of Participants | Participants |
|
| Sex: Female, Male | Parent sex | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Infant Ethnicity | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Mother Ethnicity | Count of Participants | Participants |
|
| Race (NIH/OMB) | Infant Race | Count of Participants | Participants |
|
| Race (NIH/OMB) | Mother Race | Count of Participants | Participants |
|
| Region of Enrollment | Buffalo, NY. Both members of the dyad were enrolled from the same region | Number | participants |
|
| Weight-for-length z-score | Weight for length is a measure of an infant (child under 5-years of age) height (cm) and weight (kg) scored using the World Health Organization (WHO) infant growth chart. Overweight cut-offs at a z-score between 1.0-1.99 and obese cut offs are at a z-score of >=2.0 | Mean | Standard Deviation | z-score |
|
| Mother Age | Mean | Standard Deviation | years |
|
| Household income, categorical | Count of Participants | Participants |
|
37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year.
Play Date
|
|
|
| Secondary | Infant 24-Hour Dietary Recall- Change in Energy Intake | Energy intake was measured using a 24-recall with the parent and average kcals are reported. One participant was excluded for underreporting | one participant excluded for underreporting | Posted | Mean | Standard Error | kilocalories | 0-, 12-, 24- month |
|
|
|
|
| Secondary | Change in Infant Weight-for-length Z-score | Weight for length is a measure of an infant (child under 5-years of age) height (cm) and weight (kg) scored using the World Health Organization (WHO) infant growth chart. Overweight cut-offs at a z-score between 1.0-1.99 and obese cut offs are at a z-score of >=2.0 | Intent to treat | Posted | Mean | Standard Deviation | standardized z-score | 0-, 3-, 6-, 12-, 24- month |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 0 |
| 45 |
| EG001 | Play Date | 37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year. Play Date | 0 | 45 | 0 | 45 | 0 | 45 |
Not provided
Not provided
| 24-month child average kcal |
|
| 6-month child z-weight-for-length |
|
| 12-month child z-weight-for-length |
|
| 24-month child z-weight-for-length |
|