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

  • United States
    • 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
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.

Sponsor

Arkansas Children's Hospital Research Institute

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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