Eating BehaviorNCT04723264
The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age
A study testing Food protocols in people with Eating Behavior, run by University of Michigan at 1 site in United States.
Trial summary
This study will examine children's eating behavior. The study will enroll approximately 400 participants (200 child/parent pairs). At certain time points, participants will engage in activities involving the presentation of food and the observation of behavioral responses to these presentations, as well as the… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Eating Behavior
- What is being tested?
- Food protocols
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2021to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Significant developmental delays that would impede child's ability to participate
- Foster child
- Child has developed significant health problems that affect appetite, eating, or growth.
Trial locations and contacts
1 site in 1 country.
About this study
This study will examine children's eating behavior. The study will enroll approximately 400 participants (200 child/parent pairs).
At certain time points, participants will engage in activities involving the presentation of food and the observation of behavioral responses to these presentations, as well as the completion of questionnaires
Read the detailed description
This research study is a complex, long term investigation of the relationships between children's eating behaviors, and parent-child interaction during eating and their associations with BMI and dietary intake. It builds on earlier observational research which, like this research, had small experimental components used to classify children into different phenotypic groups based on different responses to the experimental conditions. The small activities and experiments of this follow up study constitute a trial as defined by NIH, registered here. The exploratory outcomes measured from these activities are not listed in this registration for reasons of scientific integrity. To be clear, the bigger structure of this research is essentially an observational follow up study with the same children who were previously studied as infants. The goal of the project is to identify potential future intervention targets.
- Conditions
- Eating Behavior
- Being tested
- Food protocols
- Keywords
- Body mass index, Dietary quality, Children
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food protocolsBehavioural
Participants will engage in several activities (i.e. offering a variety of foods and age appropriate games, etc.) regarding eating behaviors.
Participants will be asked to videotape interactions using a secure system. An alternative option may be provided if this videotaping is not acceptable.
| Study group | Role | What they receive |
|---|---|---|
| Eating behavior activities | Experimental | Not described Receives: Behavioral: Food protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Mass Index z - score (BMIz)
Children will be weighed and measured using a portable stadiometer. BMI will be calculated and child BMI z-score derived using age- and sex-specific norms from Centers for Disease Control and Prevention (CDC) growth charts.
Measured: 1- 2 years
Secondary outcomes (1)
Dietary Intake
Mean dietary intake of macro- and micro-nutrients using an automated self-administered 24-hour dietary assessment tool across two recall days.
Measured: 1- 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start28 Apr 2021
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Julie Lumeng, University of Michigan
- Investigators
- Julie Lumeng, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723264
- Sponsor's protocol ID
- HUM00181248
- Other IDs
- R01HD084163
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2021
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The research will generate demographic, behavioral, videorecorded, and anthropometric data. (Note the researchers will not make video data available). Meta data will also be included in the selected repositories. Of note, this will include only child age, but not birthdate or date of study visit as these would violate confidentiality. The metadata will include the data dictionaries, which describe the generation of all variables.
Publications
Ventura AK, Ross KJ, Miller AL, DeJesus JM, Tan CC, Lumeng JC. Co-Development of Infant Satiation Cues and Maternal Feeding Behaviors during Infancy. Curr Dev Nutr. 2025 Sep 3;9(10):107542. doi: 10.1016/j.cdnut.2025.107542. eCollection 2025 Oct.
PubMed 41081012
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Eating Behavior in Infancy: Associations With Behavior, Diet, and Growth at School Age
- ClinicalTrials.gov ID
- NCT04723264
- Acronym / sponsor ID
- HUM00181248
- Conditions
- Eating Behavior
- Keywords
- Body mass index, Dietary quality, Children
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 28 Apr 2021 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 Jan 2021 (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.
This study will examine children's eating behavior. The study will enroll approximately 400 participants (200 child/parent pairs).
At certain time points, participants will engage in activities involving the presentation of food and the observation of behavioral responses to these presentations, as well as the completion of questionnaires
Detailed description
This research study is a complex, long term investigation of the relationships between children's eating behaviors, and parent-child interaction during eating and their associations with BMI and dietary intake. It builds on earlier observational research which, like this research, had small experimental components used to classify children into different phenotypic groups based on different responses to the experimental conditions. The small activities and experiments of this follow up study constitute a trial as defined by NIH, registered here. The exploratory outcomes measured from these activities are not listed in this registration for reasons of scientific integrity. To be clear, the bigger structure of this research is essentially an observational follow up study with the same children who were previously studied as infants. The goal of the project is to identify potential future intervention targets.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eating behavior activities | Experimental | Behavioral: Food protocols |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Significant developmental delays that would impede child's ability to participate
- Foster child
- Child has developed significant health problems that affect appetite, eating, or growth.
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 |
|---|---|---|
| Food protocolsParticipants will engage in several activities (i.e. offering a variety of foods and age appropriate games, etc.) regarding eating behaviors. Participants will be asked to videotape interactions using a secure system. An alternative option may be provided if this videotaping is not acceptable. | Behavioural | Eating behavior activities |
Primary outcome
Body Mass Index z - score (BMIz)
Time frame: 1- 2 years
Children will be weighed and measured using a portable stadiometer. BMI will be calculated and child BMI z-score derived using age- and sex-specific norms from Centers for Disease Control and Prevention (CDC) growth charts.
1 secondary outcome
Dietary Intake
Time frame: 1- 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Derived from this study: PubMed 41081012Ventura AK, Ross KJ, Miller AL, DeJesus JM, Tan CC, Lumeng JC. Co-Development of Infant Satiation Cues and Maternal Feeding Behaviors during Infancy. Curr Dev Nutr. 2025 Sep 3;9(10):107542. doi: 10.1016/j.cdnut.2025.107542. eCollection 2025 Oct.
- Individual participant dataSharing planned: Yes. The research will generate demographic, behavioral, videorecorded, and anthropometric data. (Note the researchers will not make video data available). Meta data will also be included in the selected repositories. Of note, this will include only child age, but not birthdate or date of study visit as these would violate confidentiality. The metadata will include the data dictionaries, which describe the generation of all 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, MD 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?
A study testing Food protocols in people with 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 0 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Body Mass Index z - score (BMIz) (time frame: 1- 2 years). 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 NCT04723264, 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 21 Jul 2026.