NCT03963557

Brief Summary

The child will complete computerized tasks and paper-pencil test, and will be presented with symbols, letters, or numbers on a computer screen and asked to respond by pressing a button on the computer. Before each task a researcher will explain the instructions of the task and assess if the child needs a break before completing the next task. While the child is completing computerized tasks, the parent/guardian will be asked to fill out paper-pencil questionnaires about the child and to sign a release of medical information form so that we can study how physical markers of health effect cognition.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

May 22, 2019

Last Update Submit

February 11, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Perceptual organization index- Matrix reasoning subtest

    The examinee views an incomplete matrix or series and selects the response option that completes the matrix or series. Scoring is based on whether the response is right or wrong.

    10-15 minutes

  • Perceptual organization index- Block design subtest

    The Block Design subtest is designed to measure the ability to analyze and synthesize abstract visual stimuli. While viewing a constructed model or a picture in the Stimulus Book, the examinee uses red- and-white blocks to re-create the design within a specified time limit. Scoring is based on how quickly the participant completes.

    15-20 minutes

  • Processing speed index- Coding subtest

    The processing speed index measures a child's ability efficiently to scan and understand visual information and complete a task with the data. Scoring is based on how many can the participant finish in 120 seconds.

    2-3 minutes

  • Working memory index- Digit span subtest

    The task digit span uses numbers. Memory span is a common measure of short-term memory. It is also a component of cognitive ability. Scoring is based on how many correct answers (recall) are achieved

    5-10 minutes

Study Arms (2)

Healthy participants

BMI 5th percentile to less than the 85th percentile

Overweight/Obese participants

BMI 85th percentile or more

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Local population; children and adolescents

You may qualify if:

  • Local population (based on ethnicity)
  • Healthy or overweight/obese

You may not qualify if:

  • History of developmental delay or disorders
  • History of any medical conditions ( that may impact the development)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London Diabetes Centre

Abu Dhabi, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Pediatric ObesityOrientation, Spatial

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Central Study Contacts

Dr Nader Lessan, MD FRCP CCST

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 24, 2019

Study Start

September 1, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations