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.
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
- Conditions the study is for
- Obesity, Physical Activity, Cognitive Function 1, Social
- 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.
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
- Conditions
- Obesity, Physical Activity, Cognitive Function 1, Social
- 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 group | Role | What they receive |
|---|---|---|
| Flanker test and physical fitness test | Experimental | 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. 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.
Cognition
Cognitive control was assessed using a computer-based Flanker Task.
Measured: 8 weeks
Secondary outcomes (10)
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
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
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
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
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
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
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
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
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
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.
- First posted17 Nov 2017
- Study startJun 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tennessee
- Responsible party
- Principal investigator, Arlette Perry, University of Miami
- Investigators
- Brian Anwari, Principal investigator, University of Miami
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Cognition, Fitness, and Body Composition Among Ethnic Minority Youth
- ClinicalTrials.gov ID
- NCT03342924
- Acronym / sponsor ID
- 20120584
- Conditions
- Obesity, Physical Activity, Cognitive Function 1, Social
- Keywords
- cognitive control, physical fitness, minority
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- University of Tennessee
- Study start
- Jun 2014 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flanker test and physical fitness test | Experimental | Other: Flanker Test and physical fitness testParticipants 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. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flanker Test and physical fitness testSocioeconomic 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. | Other | Flanker test and physical fitness test |
Primary outcome
Cognition
Time frame: 8 weeks
Cognitive control was assessed using a computer-based Flanker Task.
10 secondary outcomes
Socioeconomic Status
Time frame: 8 weeks
Aerobic Endurance
Time frame: 8 weeks
Arm Strength
Time frame: 8 weeks
Lower Body Power
Time frame: 8 weeks
Weight
Time frame: 8 weeks
Waist Circumference
Time frame: 8 weeks
Sagittal Abdominal Height
Time frame: 8 weeks
Percent Body Fat
Time frame: 8 weeks
Body Mass Index
Time frame: 8 weeks
Height
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Individual participant dataSharing planned: 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.
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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.
Brian Anwari principal investigator
University of Miami
1 site in 1 country: see every site and its status.
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.