Associations of Cognition, Fitness, and Body Composition Among Ethnic Minority Youth

November 14, 2017 updated by: Arlette Perry, University of Miami
Cognitive Control is crucial for learning and development. This study examined the associations between cognitive control and physical fitness and body composition among ethnic minority children.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cognitive control, or executive function, refers to a subset of goal-directed processes that are involved in perception, memory, attention, behavioral inhibition, verbal reasoning, and monitoring of actions. These aspects of cognitive control have been shown to have a direct association with academic performance, particularly mathematics and literacy. Many social and environmental factors impact the maturation of cognitive control, which can affect the growth and behavioral development of children. Physical activity has been shown to improve the functioning of the prefrontal cortex, which plays a central role in cognitive functioning. Studies have shown that children have better cognitive skills and grades when given a regimen of regular physical activity as well as executive control. Aerobic fitness has been correlated with faster reaction times as well as more accurate responses and higher prefrontal brain activity, which can enhance visuomotor function and proactive inhibition. In addition to positive health benefits, physical fitness, a product of the regular physical activity, is found to be positively associated with self-esteem, academic performance, and cognitive control. Growing evidence suggests that cognitive control may be inversely associated with obesity in childhood, adulthood, and in the elderly. The current rate of childhood obesity in the U.S. is 31.8% with poor physical fitness levels and increased sedentary behaviors as major contributors to the problem. Pediatric obesity may have negative implications on cognition, specifically memory, psychomotor speed, reaction time, complex attention, executive function and cognitive flexibility with a potential for decreased awareness or motivation in girls specifically. Overweight, inactive children, when compared to normal weight, active children, have exhibited lower planning and attention scores with detrimental effects on inhibitory control and psychosocial outcomes among girls ages nine to fifteen While new information continues to support the negative association between obesity and cognitive function, the direction of the relationship remains unclear. The extant literature also suggests that there is an inverse relationship between socioeconomic status and obesity and cognition. A recent study supported the influence of BMI on child executive control and BMI's inverse correlation with income, academic readiness, social competence and behavioral adjustment. Another study showed that white non-Hispanic and Hispanic children in fifth and seventh grades with lower socioeconomic status had a higher rate of obesity with inverse relationship most apparent in White non-Hispanic girls and fifth-grade Hispanic boys. A negative association has been observed between obesity and pattern construction in boys and vocabulary and pattern construction in girls. While there have been cross-sectional and randomized clinical trial studies correlating obesity and fitness with cognitive control, these studies fail to evaluate diverse racial/ethnic minority populations. Incorporating minority groups and gender differences into these associations are very important in generalizing findings to diverse demographics. Given the paucity of research examining the cumulative impact of obesity and physical fitness on cognition among diverse children, this study seeks to address gaps in the literature. This study utilized a comprehensive field test battery to evaluate associations among body composition, cardiovascular endurance, muscular strength and endurance, and motor skills, on executive control with gender, age, and race/ethnicity as mediators. This study is particularly relevant for Hispanic and African-American youth who show high rates of overweight and obesity

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
212

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Le Bonheur

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children were included in the study if they were: eight to 12 years old, and ethnic minority (Black and/or Hispanic/Latino), enrolled in YMCA after-school programs, able to engage in physical activities, had normal (or corrected to normal) vision based on the minimal 20/20 standard. Also, only children who were determined to be at Tanner Stages 1 or 2 (preadolescence) were included to account for the impact of puberty on measures of physical fitness and cognition.

Exclusion Criteria:

  • Children who had prior or current metabolic, cardiovascular, or neurological disorders, and/or medication regimens that could interfere with evaluation of cognitive function were excluded from the study.

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Flanker test and physical fitness test
Participants performed a computer-based Flanker Task measuring cognitive control and physical fitness tests: two-minute walk, vertical jump, one-minute curl-ups, and handgrip strength. Body composition variables included: body mass index, percent body fat, waist circumference, and sagittal abdominal height. General linear models were performed to evaluate impacts of physical fitness and body composition on cognition, adjusting for age and sex.
Other: Flanker Test and physical fitness test
Socioeconomic status was determined using a trichotomous index. Inbody was used to assess body composition. To assess physical fitness, certain field tests were implemented using devices to quantify precise actions of physicality. Cognitive control was assessed using a computer-based Flanker Task.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cognition
Time Frame: 8 weeks
Cognitive control was assessed using a computer-based Flanker Task.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Socioeconomic Status
Time Frame: 8 weeks
Socioeconomic status was determined using a trichotomous index developed by Birnbaum et al. 2002 based on participation in free or reduced-price lunch program at school, the highest level of education attained by the mother and father, and the number of parents who worked full-time.
8 weeks
Aerobic Endurance
Time Frame: 8 weeks
To assess physical fitness, certain field tests were implemented using devices to quantify precise actions of physicality. The NIH Toolbox two-minute Walk Endurance test was used to assess aerobic endurance.
8 weeks
Arm Strength
Time Frame: 8 weeks
To assess physical fitness, certain field tests were implemented using devices to quantify precise actions of physicality.. A Jamar Plus handgrip dynamometer was used to assess right and left arm strength (kg).
8 weeks
Lower Body Power
Time Frame: 8 weeks
To assess physical fitness, certain field tests were implemented using devices to quantify precise actions of physicality. To assess lower body power, a counter movement vertical jump was used.
8 weeks
Weight
Time Frame: 8 weeks
The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included body weight, which was measured in pounds.
8 weeks
Waist Circumference
Time Frame: 8 weeks
Waist circumference was used as a determinant of central obesity and was measured in centimeters using a Gulick spring loaded measuring tape.
8 weeks
Sagittal Abdominal Height
Time Frame: 8 weeks
A portable anthropometer was used to measure sagittal abdominal height in centimeters as an indirect measure of visceral adiposity.
8 weeks
Percent Body Fat
Time Frame: 8 weeks
The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included percent body fat.
8 weeks
Body Mass Index
Time Frame: 8 weeks
The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included Body Mass Index.
8 weeks
Height
Time Frame: 8 weeks
Height was measured using a Weigh Beam Eye-Level physicians' scale
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Miami

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Tennessee Health Science Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian Anwari, University of Miami

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 14, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20120584

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Only the study investigators and/or sponsor will monitor the plan for data and safety monitoring for this study. Shared data will be done through encrypted files and file management platform OneDrive.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Obesity

Clinical Trials on Flanker Test and physical fitness test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings