Healthy ChildrenNCT02636998
Nutrition and Cognitive Function in Preadolescents
An observational study of Healthy Children, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
This study is designed to evaluate cognitive function in preadolescents who have different body mass indexes. Read more about this study
- Who is it for?
- Ages 9 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Dec 2025
- 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 9 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preadolescents and their mothers
Who may be able to join
- Normal weight (BMI: <85th percentile) or obese (BMI: >95th percentile)
- Right hand dominance
- Report eating breakfast at least 4 days/week
- Able to hear at least 20 dB stimulus
- Visual acuity must be at least 20/40
- Arithmetic Computation Task
- Biological mother available to attend the enrollment study visit
Who cannot join
- Full Scale IQ <80
- Children taking medications or having chronic illnesses/disorders that may independently affect study outcome measures (as determined by the PI)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Nutrition Center
Little Rock, Arkansas, 72202
About this study
This study is designed to evaluate cognitive function in preadolescents who have different body mass indexes.
Read the detailed description
The investigators plan to document differences between normal weight and obese preadolescents on psychological and neurocognitive measures of executive function controlling for factors known to influence brain function and behavior not considered in previous studies.
- Conditions
- Healthy Children
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 |
|---|---|---|
| Normal weight | BMI <85th percentile | |
| Obese | BMI > 95th percentile |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological assessments
Standardized assessments
Measured: 9-10 years
Neurocognitive measures
Brain Lab Recordings
Measured: 9-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJun 2015
- Primary completion6 Jan 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Larson-Prior, Ph.D, Principal investigator, Arkansas Children's Nutrition Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636998
- Sponsor's protocol ID
- 204071
- Status last verified
- Sep 2024
- First submitted
- 22 Jun 2015
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition and Cognitive Function in Preadolescents
- ClinicalTrials.gov ID
- NCT02636998
- Acronym / sponsor ID
- 204071
- Conditions
- Healthy Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- 6 Jan 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Dec 2015 (estimated)
- 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 is designed to evaluate cognitive function in preadolescents who have different body mass indexes.
Detailed description
The investigators plan to document differences between normal weight and obese preadolescents on psychological and neurocognitive measures of executive function controlling for factors known to influence brain function and behavior not considered in previous studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal weight | – | –BMI <85th percentile |
| Obese | – | –BMI > 95th percentile |
Who may qualify
- Ages
- 9 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preadolescents and their mothers
Key inclusion criteria (7 listed)
- Normal weight (BMI: <85th percentile) or obese (BMI: >95th percentile)
- Right hand dominance
- Report eating breakfast at least 4 days/week
- Able to hear at least 20 dB stimulus
- Visual acuity must be at least 20/40
Key exclusion criteria (2 listed)
- Full Scale IQ <80
- Children taking medications or having chronic illnesses/disorders that may independently affect study outcome measures (as determined by the PI)
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
Psychological assessments
Time frame: 9-10 years
Standardized assessments
Neurocognitive measures
Time frame: 9-10 years
Brain Lab Recordings
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
Linda Larson-Prior, Ph.D principal investigator
Arkansas Children's Nutrition Center
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 Healthy Children, run by Arkansas Children's Hospital Research Institute 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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jan 2025. 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?
Results are not available in the source record.
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?
Psychological assessments (time frame: 9-10 years). The study lists 2 primary outcomes in all. 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 29 Jan 2025.