Self-regulationNCT06108128
Food for Thought: Executive Functioning Around Eating Among Children
A study testing Executive functioning observational tasks in people with Self-regulation and Appetitive Behavior, run by Temple University at 1 site in United States.
Trial summary
Scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited. This investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make… Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Self-regulation, Appetitive Behavior, Eating Behavior
- What is being tested?
- Executive functioning observational tasks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2023to 29 Jun 2026
- Phase
- Interventional
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child ages 4 to 6 years of age
- Caregiver reporting primary responsibility for child feeding outside of childcare
- Caregiver legal guardian
Who cannot join
- Caregiver <18 years of age
- Child major food allergies
- Child medication use, developmental disability, or medical conditions known to affect food intake and/or growth; color blindness
- Child in foster care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing Top-down Dimensions of Appetite Self-regulation Among Preschoolers
Scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited. This investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make healthy food choices and eat in moderation.
Read the detailed description
Appetite self-regulation (ASR) has been described as involving children's use of eating-specific, "top-down" cognitive processes to moderate "bottom-up" biological drives to eat. Much of the research to date on ASR has focused on the role of bottom-up drives in shaping children's behavioral susceptibility to obesity. Alternatively, little is known about the cognitive-developmental processes that shape children's ability to make healthy food choices and eat in moderation during early childhood. The goal of this exploratory investigation is to produce rigorous evidence of cognitive developmental influences on healthy eating behaviors and weight status during preschool through the development of new measures of top-down ASR. Participants will be 125 preschoolers and their primary caregiver. Existing measures of executive functioning in children will be adapted to create new measures of eating-specific, top-down ASR. Associations with children's eating behaviors, body mass index z-scores, food parenting will be assessed.
- Conditions
- Self-regulation, Appetitive Behavior, Eating Behavior, Child Obesity
- Being tested
- Executive functioning observational tasks
- Medical subject headings
- Self-Control, Appetitive Behavior, Feeding Behavior, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Executive functioning observational tasksOther
Interventions take place solely at the measurement level, where children will be seen in observational tasks of general executive functioning and executive functioning around eating in which various food and non-food stimuli are presented and children's responses to task instructions are recorded.
| Study group | Role | What they receive |
|---|---|---|
| Caregiver-child dyads | Other | Observational study of executive functioning around eating and parenting Receives: Other: Executive functioning observational tasks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Food choice
Children's forced-choice selection of fruits, vegetables, and water over alternatives at a meal
Measured: Assessed at 1 of 2 study visits over 2 weeks
Eating in the absence of hunger
Children's intake of palatable foods following a standard meal
Measured: Assessed at 1 of 2 study visits over 2 weeks
Body mass index z-score
Age and sex specific z-score using CDC reference data
Measured: Assessed at 1 of 2 study visits over 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start5 Oct 2023
- Primary completion29 Jun 2026
- Study completion29 Jun 2026
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 Self-regulationStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an observational, cross-sectional study that involves interventions ONLY at the measurement level.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor College of Medicine, University of Nevada, Reno
- Responsible party
- Principal investigator, Jennifer Orlet Fisher, Temple University
- Investigators
- Jennifer O Fisher, PHD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108128
- Sponsor's protocol ID
- R21HD109362
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Research data generated by the project will be supported by TUScholarShare (https://scholarshare.temple.edu/), the institutional repository for Temple University. This is a repository service that is managed by the Temple University Libraries and uses Open Repository, an enhanced DSpace platform that is hosted by Atmire. TUScholarShare has been developed with the intent of helping researchers comply with grant-funding agency requirements. It enables dissemination and long-term preservation and curation (management, use, and re-use) of data.
Publications
Russell CG, Russell A. "Food" and "non-food" self-regulation in childhood: a review and reciprocal analysis. Int J Behav Nutr Phys Act. 2020 Mar 10;17(1):33. doi: 10.1186/s12966-020-00928-5.
PubMed 32151265
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Top-down Dimensions of Appetite Self-regulation Among Preschoolers
- ClinicalTrials.gov ID
- NCT06108128
- Acronym / sponsor ID
- R21HD109362
- Conditions
- Self-regulation, Appetitive Behavior, Eating Behavior, Child Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- Baylor College of Medicine, University of Nevada, Reno
- Study start
- 5 Oct 2023 (actual)
- Primary completion
- 29 Jun 2026 (actual)
- Study completion
- 29 Jun 2026 (actual)
- First posted
- 30 Oct 2023 (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.
Scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited. This investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make healthy food choices and eat in moderation.
Detailed description
Appetite self-regulation (ASR) has been described as involving children's use of eating-specific, "top-down" cognitive processes to moderate "bottom-up" biological drives to eat. Much of the research to date on ASR has focused on the role of bottom-up drives in shaping children's behavioral susceptibility to obesity. Alternatively, little is known about the cognitive-developmental processes that shape children's ability to make healthy food choices and eat in moderation during early childhood. The goal of this exploratory investigation is to produce rigorous evidence of cognitive developmental influences on healthy eating behaviors and weight status during preschool through the development of new measures of top-down ASR. Participants will be 125 preschoolers and their primary caregiver. Existing measures of executive functioning in children will be adapted to create new measures of eating-specific, top-down ASR. Associations with children's eating behaviors, body mass index z-scores, food parenting will be assessed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an observational, cross-sectional study that involves interventions ONLY at the measurement level.
| Arm | Type | Receives |
|---|---|---|
| Caregiver-child dyads | Other | Other: Executive functioning observational tasksObservational study of executive functioning around eating and parenting |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child ages 4 to 6 years of age
- Caregiver reporting primary responsibility for child feeding outside of childcare
- Caregiver legal guardian
Key exclusion criteria (4 listed)
- Caregiver <18 years of age
- Child major food allergies
- Child medication use, developmental disability, or medical conditions known to affect food intake and/or growth; color blindness
- Child in foster care
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 |
|---|---|---|
| Executive functioning observational tasksInterventions take place solely at the measurement level, where children will be seen in observational tasks of general executive functioning and executive functioning around eating in which various food and non-food stimuli are presented and children's responses to task instructions are recorded. | Other | Caregiver-child dyads |
Primary outcome
Food choice
Time frame: Assessed at 1 of 2 study visits over 2 weeks
Children's forced-choice selection of fruits, vegetables, and water over alternatives at a meal
Eating in the absence of hunger
Time frame: Assessed at 1 of 2 study visits over 2 weeks
Children's intake of palatable foods following a standard meal
Body mass index z-score
Time frame: Assessed at 1 of 2 study visits over 2 weeks
Age and sex specific z-score using CDC reference data
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 28 Sep 2026.
- Background: PubMed 32151265Russell CG, Russell A. "Food" and "non-food" self-regulation in childhood: a review and reciprocal analysis. Int J Behav Nutr Phys Act. 2020 Mar 10;17(1):33. doi: 10.1186/s12966-020-00928-5.
- Individual participant dataSharing planned: Yes. Research data generated by the project will be supported by TUScholarShare (https://scholarshare.temple.edu/), the institutional repository for Temple University. This is a repository service that is managed by the Temple University Libraries and uses Open Repository, an enhanced DSpace platform that is hosted by Atmire. TUScholarShare has been developed with the intent of helping researchers comply with grant-funding agency requirements. It enables dissemination and long-term preservation and curation (management, use, and re-use) of data.
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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.
Jennifer O Fisher, PHD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Executive functioning observational tasks in people with Self-regulation and Appetitive Behavior, run by Temple University 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 3 inclusion and 4 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 28 Sep 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?
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?
Food choice (time frame: Assessed at 1 of 2 study visits over 2 weeks). The study lists 3 primary outcomes in all. 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 NCT06108128, 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 28 Sep 2026.