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ObesityNCT03342924

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

A study testing Flanker Test and physical fitness test in people with Obesity and Physical Activity, run by University of Miami at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 8 to 12 years
What is being tested?
Flanker Test and physical fitness test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteUnited States
Study dates
Jun 2014to Jun 2014
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 8 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Le Bonheur

    Memphis, Tennessee, 38103

Other trials in United States

About this study

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.

Read the 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

Being tested
Flanker Test and physical fitness test
Keywords
cognitive control, physical fitness, minority
Medical subject headings
Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flanker Test and physical fitness testOther

    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.

Study groups in NCT03342924
Study groupRoleWhat they receive
Flanker test and physical fitness testExperimentalParticipants 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.
Receives: Other: Flanker Test and physical fitness test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognition

    Cognitive control was assessed using a computer-based Flanker Task.

    Measured: 8 weeks

Secondary outcomes (10)
  1. Socioeconomic Status

    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.

    Measured: 8 weeks

  2. Aerobic Endurance

    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.

    Measured: 8 weeks

  3. Arm Strength

    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).

    Measured: 8 weeks

  4. Lower Body Power

    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.

    Measured: 8 weeks

  5. Weight

    The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included body weight, which was measured in pounds.

    Measured: 8 weeks

  6. Waist Circumference

    Waist circumference was used as a determinant of central obesity and was measured in centimeters using a Gulick spring loaded measuring tape.

    Measured: 8 weeks

  7. Sagittal Abdominal Height

    A portable anthropometer was used to measure sagittal abdominal height in centimeters as an indirect measure of visceral adiposity.

    Measured: 8 weeks

  8. Percent Body Fat

    The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included percent body fat.

    Measured: 8 weeks

  9. Body Mass Index

    The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included Body Mass Index.

    Measured: 8 weeks

  10. Height

    Height was measured using a Weigh Beam Eye-Level physicians' scale

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2017
  2. Study startJun 2014
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

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
Masking
None (open label)
Enrolment
212 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03342924
Sponsor's protocol ID
20120584
Status last verified
Nov 2017
First submitted
13 Jul 2017
Last updated
17 Nov 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Flanker Test and physical fitness test in people with Obesity and Physical Activity, run by University of Miami 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 1 inclusion and 1 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 17 Nov 2017. 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?

Cognition (time frame: 8 weeks). 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 17 Nov 2017.

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Clinical Trial NCT03342924 | AzTrials