Infant DevelopmentNCT02936284
Infant Environment Study
A study testing Music Enhancement and Play Date in people with Infant Development and Motivation, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Motivation
- What is being tested?
- Music Enhancement and Play Date
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Jul 2021
- 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 15 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- High food reinforcement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Alternatives to Eating in Infancy
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.
Read the detailed description
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.
- Conditions
- Infant Development, Motivation
- Being tested
- Music Enhancement, Play Date
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music EnhancementBehavioural
Play DateBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Music Enhancement | Experimental | 37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year. Receives: 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. Receives: Behavioral: Play Date |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-, 3-, 6-, 12-, 24- month
Secondary outcomes (2)
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
Measured: 0-, 12-, 24- month
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
Measured: 0-, 3-, 6-, 12-, 24- month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2021
- Study completionJul 2021
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 (3)Papers the sponsor has linked to this study.
- Other trials for Infant DevelopmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Leonard Epstein, State University of New York at Buffalo
- Investigators
- Leonard Epstein, Ph.D, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02936284
- Sponsor's protocol ID
- 1134699-1-75860
- Other IDs
- 1R01HD087082-01A1
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2016
- Last updated
- 4 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be shared upon request to PI
Publications
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.
PubMed 37823562Kong 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.
PubMed 36250608Kong 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.
PubMed 35021890
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Alternatives to Eating in Infancy
- ClinicalTrials.gov ID
- NCT02936284
- Acronym / sponsor ID
- 1134699-1-75860
- Conditions
- Infant Development, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Nov 2016
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 4 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Enhancement | Experimental | Behavioral: Music Enhancement37 weekly Music Together classes for one year, then 12 monthly Music Together classes the following year. |
| Play Date | Active comparator | Behavioral: Play Date37 weekly group Play Date sessions for one year, then 12 monthly group Play Date sessions the following year. |
Who may qualify
- Ages
- 9 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- High food reinforcement
Key exclusion criteria (5 listed)
- 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
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 Enhancement | Behavioural | Music Enhancement |
| Play Date | Behavioural | Play Date |
Primary outcome
Change in Infant Food Reinforcing Proportion
Time frame: 0-, 3-, 6-, 12-, 24- month
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
2 secondary outcomes
Infant 24-Hour Dietary Recall- Change in Energy Intake
Time frame: 0-, 12-, 24- month
Change in Infant Weight-for-length Z-score
Time frame: 0-, 3-, 6-, 12-, 24- month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37823562Smith 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.
- Derived from this study: PubMed 36250608Kong 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.
- Derived from this study: PubMed 35021890Kong 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.
- Individual participant dataSharing planned: No. Data will be shared upon request to PI
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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.
Leonard Epstein, Ph.D principal investigator
University at Buffalo
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 Enhancement and Play Date in people with Infant Development and Motivation, run by State University of New York at Buffalo 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 1 inclusion and 5 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 4 Sep 2024. 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. 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 4 Sep 2024). 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?
Change in Infant Food Reinforcing Proportion (time frame: 0-, 3-, 6-, 12-, 24- month). 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 NCT02936284, which also lists 3 linked publications.
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 4 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.