- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636998
Nutrition and Cognitive Function in Preadolescents
December 18, 2023 updated by: Arkansas Children's Hospital Research Institute
This study is designed to evaluate cognitive function in preadolescents who have different body mass indexes.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
116
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Arkansas
-
Little Rock, Arkansas, United States, 72202
- Arkansas Children's Nutrition Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years to 11 years (Child)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Preadolescents and their mothers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Full Scale IQ <80
- Children taking medications or having chronic illnesses/disorders that may independently affect study outcome measures (as determined by the PI)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Normal weight
BMI <85th percentile
|
Obese
BMI > 95th percentile
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Psychological assessments
Time Frame: 9-10 years
|
Standardized assessments
|
9-10 years
|
Neurocognitive measures
Time Frame: 9-10 years
|
Brain Lab Recordings
|
9-10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Linda Larson-Prior, Ph.D, Arkansas Children's Nutrition Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2015
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
December 1, 2023
Study Registration Dates
First Submitted
June 22, 2015
First Submitted That Met QC Criteria
December 18, 2015
First Posted (Estimated)
December 22, 2015
Study Record Updates
Last Update Posted (Actual)
December 20, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 204071
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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