NCT03342924

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2017

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

Same day

First QC Date

July 13, 2017

Last Update Submit

November 14, 2017

Conditions

Keywords

cognitive controlphysical fitnessminority

Outcome Measures

Primary Outcomes (1)

  • Cognition

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

    8 weeks

Secondary Outcomes (10)

  • Socioeconomic Status

    8 weeks

  • Aerobic Endurance

    8 weeks

  • Arm Strength

    8 weeks

  • Lower Body Power

    8 weeks

  • Weight

    8 weeks

  • +5 more secondary outcomes

Study Arms (1)

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.

Other: Flanker Test and physical fitness test

Interventions

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.

Flanker test and physical fitness test

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Le Bonheur

Memphis, Tennessee, 38103, United States

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Brian Anwari

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2017

First Posted

November 17, 2017

Study Start

June 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

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.

Locations