An interventional study of Flanker Test and physical fitness test in Obesity, Physical Activity and Cognitive Function 1, Social, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 8 Years to 12 Years. Per ClinicalTrials.gov, last updated 2017-11-17.
Sponsored by University of Miami · Not applicable, Interventional, and Other
Among 24 studies in Obesity by University of Miami — 3 open to participants now, 3 under way, none of them phase 3. Obesity · University of Miami.
Among the 24 studies in Obesity by University of Miami, this one is the 7th largest by enrollment of the 23 interventional ones that give a count, is one of 3 that started in 2014, is one of 19 with no phase, and was the 14th registered.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →3 of the 24 studies in Obesity by University of Miami are open now, in 1 country. Recruiting first, the newest first:
University of Miami · Sites in United States
University of Miami · Sites in United States
University of Miami · Sites in United States
By country, each count listing its studies:
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.
This study: 8 Years to 12 Years · all sexes · no healthy volunteers.
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24 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 3 started in 2014.
This study's enrollment of 212 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Median enrollment 35 across the 23 interventional studies, 960 across the 1 observational. Of the 19 that completed or were terminated, 7 (37%) have results posted.
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University of Miami is the lead sponsor of 840 studies on the registry; 164 are open to participants now.
Of its 115 completed or terminated interventional studies of FDA-regulated products, 97 (84%) have results posted.
1 of the studies in Obesity by University of Miami that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06003686University of MiamiSpinal Cord Injury Model Systems (SCIMS) - Education Module | 2026-12-31 |
Among the 24 studies in Obesity by University of Miami, from their registry updates:
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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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Cognition
Cognitive control was assessed using a computer-based Flanker Task.
Time frame: 8 weeks
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 8 weeks
Sagittal Abdominal Height
A portable anthropometer was used to measure sagittal abdominal height in centimeters as an indirect measure of visceral adiposity.
Time frame: 8 weeks
Percent Body Fat
The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included percent body fat.
Time frame: 8 weeks
Body Mass Index
The Inbody-520 multi-frequency bioimpedance analyzer was used to assess body composition. Information recorded included Body Mass Index.
Time frame: 8 weeks
Height
Height was measured using a Weigh Beam Eye-Level physicians' scale
Time frame: 8 weeks
Plan to share: 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.
No publications or documents are linked to this record.
Ran from Jun 2014 to primary completion in Jun 2014, 0 months.
Of 3,680 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 0 months is below that.
Counting every sponsor, half of 3,843 studies reached it within 22 months; a quarter within 10 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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