Obesity, ChildhoodNCT03963557
Cognitive Function and Body Mass Index in Children and Adolescents
An observational study of Obesity, Childhood and Obesity, Adolescent, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Obesity, Adolescent, Cognitive Orientation
- How many people
- 100 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Sep 2018to Dec 2020
- Phase
- Observational
- 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 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Local population; children and adolescents
Who may be able to join
- Local population (based on ethnicity)
- Healthy or overweight/obese
Who cannot join
- History of developmental delay or disorders
- History of any medical conditions ( that may impact the development)
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Imperial College London Diabetes Centre
Abu Dhabi
Dr Nader Lessan, MD FRCP CCST
About this study
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.
- Medical subject headings
- Pediatric Obesity, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy participants | BMI 5th percentile to less than the 85th percentile | |
| Overweight/Obese participants | BMI 85th percentile or more |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start1 Sep 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London Diabetes Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Georgetown University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963557
- Sponsor's protocol ID
- IREC035
- Status last verified
- Feb 2020
- First submitted
- 22 May 2019
- Last updated
- 12 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function and Body Mass Index in Children and Adolescents
- ClinicalTrials.gov ID
- NCT03963557
- Acronym / sponsor ID
- IREC035
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Imperial College London Diabetes CentreUniversity, hospital or other
- Collaborators
- Georgetown University
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 24 May 2019 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy participants | – | –BMI 5th percentile to less than the 85th percentile |
| Overweight/Obese participants | – | –BMI 85th percentile or more |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Local population; children and adolescents
Key inclusion criteria (2 listed)
- Local population (based on ethnicity)
- Healthy or overweight/obese
Key exclusion criteria (2 listed)
- History of developmental delay or disorders
- History of any medical conditions ( that may impact the development)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perceptual organization index- Matrix reasoning subtest
Time frame: 10-15 minutes
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.
Perceptual organization index- Block design subtest
Time frame: 15-20 minutes
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.
Processing speed index- Coding subtest
Time frame: 2-3 minutes
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.
Working memory index- Digit span subtest
Time frame: 5-10 minutes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Obesity, Adolescent, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 12 Feb 2020. 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 Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Nader Lessan, MD FRCP CCST (+97124040800 ext. 970, nlessan@icldc.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceptual organization index- Matrix reasoning subtest (time frame: 10-15 minutes). The study lists 4 primary outcomes in all. 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 12 Feb 2020.