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Cognitive Function and Body Mass Index in Children and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03963557
Recruitment Status : Recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Georgetown University
Information provided by (Responsible Party):
Imperial College London Diabetes Centre

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.

Condition or disease
Obesity, Childhood Obesity, Adolescent Cognitive Orientation

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cognitive Function and Body Mass Index in Children and Adolescents
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Healthy participants
BMI 5th percentile to less than the 85th percentile
Overweight/Obese participants
BMI 85th percentile or more

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Local population; children and adolescents

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03963557

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Contact: Dr Nader Lessan, MD FRCP CCST +97124040800 ext 970

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United Arab Emirates
Imperial College London Diabetes Centre Recruiting
Abu Dhabi, United Arab Emirates
Contact: Dr Nader Lessan, MD FRCP CCST         
Sponsors and Collaborators
Imperial College London Diabetes Centre
Georgetown University

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Responsible Party: Imperial College London Diabetes Centre Identifier: NCT03963557     History of Changes
Other Study ID Numbers: IREC035
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms