Eating BehaviorNCT04114123
The Development of Reward Response to Food in Infancy
An observational study of Eating Behavior, run by University of Michigan at 1 site in United States.
Trial summary
In this study the researchers want to learn more about reward-driven eating behavior in children ages 2 to 18 months. The researchers hope to use this knowledge to help inform obesity prevention programs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Eating Behavior
- How many people
- 1,166 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 19 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The researchers will enroll infants and their mothers (age limit given is for minimum age for mothers) from the community and from sites allowed and approved by the IRB like pediatric clinics and childcare centers. They will be recruiting participants living within a 50 mile radius around Ann Arbor, MI.
Who may be able to join
- Baby is alive
- Baby is 6 to 16 weeks old at time of enrollment
- Baby and mother receive care at Michigan Medicine, and specifically:
- Baby was born at Michigan medicine
- Baby has had a 2 month well child check
- Mother received prenatal care at Michigan Medicine
Show all 16Show fewer
- Mother has a linked patient profile to baby's profile
- Baby has a length and weight measurement on record
- Mother is English speaking
- Enrolled in longitudinal arm of study
- Eligible to complete all three protocols (Two Oatmeal and Reaching) as per protocol screeners
- Baby is alive
- Baby is 5 to 7 months old at the time of enrollment
- Mother is biological mother
- Mother is legal guardian
- Mother is English speaking
Who cannot join
- Baby is a foster child
- Baby was still in hospital 4 days after birth
- Baby has severe perinatal or neonatal medical problems
- Baby has severe developmental delays
- Multiple births
- For the Cross Sectional:
Show all 12Show fewer
- Baby had severe perinatal or neonatal medical problems
- Baby currently has severe medical problems
- Baby has severe developmental delays
- Mom had severe complications during pregnancy
- Multiple Births
- Food allergies
Trial locations and contacts
1 site in 1 country.
About this study
In this study the researchers want to learn more about reward-driven eating behavior in children ages 2 to 18 months. The researchers hope to use this knowledge to help inform obesity prevention programs.
Read the detailed description
The study will comprise two arms and each arm has a different time perspective. The longitudinal arm is prospective in nature and the cross-sectional arm has a cross-sectional time perspective. The video observation is completed at a single time point (although standardized by inclusion criteria).
- Conditions
- Eating Behavior
- Keywords
- Reward-driven Eating, Infant, Maternal
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal | The researchers will be evaluating baseline indicators of wanting salience and liking between 2 and 6 month olds, with the goal of following up with these families at 24 months and beyond by reviewing the dyads' medical charts. The researchers will also examine direct and indirect associations between reward-driven eating, and maternal and infant characteristics and infant weight-for-length. | |
| Cross-sectional | The researchers will as the mother to answer questionnaires and participate in up to two video taped behavioral protocols when the infant is 6 months old. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of trajectory membership and body mass index z-score (BMIz)
Trajectory membership could be "wanting", "salience", or "liking"
Measured: Time Frame: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start13 Nov 2019
- Primary completion19 Jun 2024
- Study completion19 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating BehaviorStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Julie Lumeng, University of Michigan
- Investigators
- Julie Lumeng, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114123
- Sponsor's protocol ID
- HUM00164906
- Status last verified
- Nov 2024
- First submitted
- 1 Oct 2019
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research will generate demographic, anthropometric, dietary, behavioral questionnaire, and coded behavioral data. (Note the researchers will not make video data available.) The data will be stored as Statistical Package for the Social Sciences (SPSS) or Statistical Analysis System (SAS) files. Meta data will also be included in the selected repositories.The meta data will include the data dictionaries, which describe the generation of all variables, as well as the protocol manuals describing the behavioral protocols used to generate the variables.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Reward Response to Food in Infancy
- ClinicalTrials.gov ID
- NCT04114123
- Acronym / sponsor ID
- HUM00164906
- Conditions
- Eating Behavior
- Keywords
- Reward-driven Eating, Infant, Maternal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,166 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 19 Jun 2024 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the researchers want to learn more about reward-driven eating behavior in children ages 2 to 18 months. The researchers hope to use this knowledge to help inform obesity prevention programs.
Detailed description
The study will comprise two arms and each arm has a different time perspective. The longitudinal arm is prospective in nature and the cross-sectional arm has a cross-sectional time perspective. The video observation is completed at a single time point (although standardized by inclusion criteria).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Longitudinal | – | –The researchers will be evaluating baseline indicators of wanting salience and liking between 2 and 6 month olds, with the goal of following up with these families at 24 months and beyond by reviewing the dyads' medical charts. The researchers will also examine direct and indirect associations between reward-driven eating, and maternal and infant characteristics and infant weight-for-length. |
| Cross-sectional | – | –The researchers will as the mother to answer questionnaires and participate in up to two video taped behavioral protocols when the infant is 6 months old. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The researchers will enroll infants and their mothers (age limit given is for minimum age for mothers) from the community and from sites allowed and approved by the IRB like pediatric clinics and childcare centers. They will be recruiting participants living within a 50 mile radius around Ann Arbor, MI.
Key inclusion criteria (16 listed)
- Baby is alive
- Baby is 6 to 16 weeks old at time of enrollment
- Baby and mother receive care at Michigan Medicine, and specifically:
- Mother is English speaking
- Enrolled in longitudinal arm of study
Key exclusion criteria (12 listed)
- Baby is a foster child
- Baby was still in hospital 4 days after birth
- Baby has severe perinatal or neonatal medical problems
- Baby has severe developmental delays
- Multiple births
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of trajectory membership and body mass index z-score (BMIz)
Time frame: Time Frame: 24 months
Trajectory membership could be "wanting", "salience", or "liking"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Yes. The research will generate demographic, anthropometric, dietary, behavioral questionnaire, and coded behavioral data. (Note the researchers will not make video data available.) The data will be stored as Statistical Package for the Social Sciences (SPSS) or Statistical Analysis System (SAS) files. Meta data will also be included in the selected repositories.The meta data will include the data dictionaries, which describe the generation of all variables, as well as the protocol manuals describing the behavioral protocols used to generate the variables.
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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.
Julie Lumeng principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Behavior, run by University of Michigan 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 16 inclusion and 12 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 26 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association of trajectory membership and body mass index z-score (BMIz) (time frame: Time Frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2024.