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Sedentary Behavior;Cognition;Cardiovascular-related DiseaseNCT03582709

Prospective Cohort Study on Cognition and Cardiovascular Disease of Sedentary Behaviors in Children

An observational study of Sedentary Behavior;Cognition;Cardiovascular-related Disease, run by CHEN Yajun.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Official record
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Trial summary

The prospective cohort study is set up to address research questions dealing with sedentary lifestyle-related events mainly including cognition and cardiovascular-related disease in children .Participants aged 7-12 years old from five primary schools in Guangzhou,Guangdong province will be recruited and followed up to… Read more about this study

Who is it for?
Ages 7 to 12 years
How many people
1,000 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 12 years
  • All sexes
  • Child

Study population: Primary school students aged 7 to 12 in Guangzhou

Who may be able to join

  • 7-12 years old
  • Children with normal intelligence measured by Raven Good vision.
  • Right hand.

Who cannot join

  • Children with mental health and behavioral problems in this study were found to have developmental behavior disorders, such as ADHD, ASD.
  • There are serious liver and kidney diseases, cardiovascular diseases, hematologic diseases or malignant tumors.

About this study

The prospective cohort study is set up to address research questions dealing with sedentary lifestyle-related events mainly including cognition and cardiovascular-related disease in children .Participants aged 7-12 years old from five primary schools in Guangzhou,Guangdong province will be recruited and followed up to evaluate the risk factors of cognition and cardiovascular-related disease. Objective measurements combined with questionnaire-data-based information on a wide range of lifestyle factors and cognition were applied in this study.

Read the detailed description

There are three stages in this project.At first stage,information about socio-demographic, psychological status, physical activity,sleep and diet were collected by a multi-components questionnaire survey.The Strengths and Difficulties Questionnaire(SDQ) and Behavior Rating Inventory of Executive Function(BRIEF) were conducted at the same time. Anthropometric measurement including height, weight, waist and hip circumferences, blood pressure and fat mass were conducted.Besides,blood samples were collected to measure total cholesterol, triglycerides, high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C).

At second stage,participants were classified for 4 subgroups as follows: Low active-high sedentary;low active-low sedentary; high active-high sedentary;high active-low sedentary by different sedentary status and physical activity levels according to the international standard. Later cardiorespiratory fitness was assessed by the 20-m shuttle run test. Accelerometer GT3X+ Actigraph with physical activity log,Combined Raven's test, a series of psychometric paradigms were measured for further studies.

At third stage,we will explore the related neuropsychological mechanism using the technology of event-related potentials (ERPs).

About 1000 participants (7-12 years old) will be prospectively followed up. The associations between sedentary lifestyle and risks for cognition and cardiovascular-related disease will be evaluated.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-reported physical activity and sedentary lifestyle.

    Using International Physical Activity Questionnaire-Short-Chinese(IPAQ-S-C)to assess the frequency and duration of activity and sedentary lifestyle(SL) in the last 7 days .Subjects with moderate activity and vigorous activity(MVPA)≥60min/day were classified into high PA subgroup while those with MVPA<150min/week were classified into low PA subgroup according to the international standard.Subjects with SL≥gender-, age-specific 75% percentile were assigned to the high SL subgroup and< gender-, age-specific 25% percentile were assigned to the low SL subgroup.

    Measured: 2017.01-2026.12

Secondary outcomes (10)
  1. Anthropometric

    Height was measured to the nearest millimeter and weight was measured to the nearest 0.1kg.Waist circumference(WC) was measured to the nearest millimeter at the level of 1cm above umbilicus with a steel tape. Body mass index(BMI) was calculated as body weight in kilograms divided by height in meters squared (kg/m2).Human body fat mass was measured by means of the bio-impedance assay ( BIA ) .Blood pressure was recorded as systolic blood pressure (SBP) and diastolic blood pressure (DBP) . Blood pressure was measured for 2 times with one-minute interval.

    Measured: 2017.01-2026.12

  2. Biochemical indicator

    Fasting blood glucose,total cholesterol, triglycerides, high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C).

    Measured: 2017.01-2026.12

  3. Cardiorespiratory Fitness(CRF)

    CRF was assessed by the 20-m shuttle run test.Estimations of submaximal oxygen consumption (VO2max) were obtained using Leger's formulae.

    Measured: 2017.01-2026.12

  4. Self-reported cognition

    The Behavior Rating Inventory of Executive Function-Parents(BRIEF-P) examines parents' report for the frequency of "problematic" behaviors that their child displayed at home during the previous 6 months. It contains 86 items (every item chooses from three dimensions "No", "Sometimes" and "Often" ) within eight theoretically and empirically derived clinical scales that measure different aspects of executive functioning: Inhibit, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Organization of Materials and Monitor, and three overarching composites (i.e. Behavioral Index [BRI, obtained Inhibit, Shift, Emotional Control], Metacognition Index [MI, obtained Initiate, Working Memory, Plan/Organize, Organization of Materials and Monitor] and Global Executive Composite [GEC]).The higher the score, the worse the executive function.

    Measured: 2017.01-2026.12

  5. Objective measurement of physical activity and sedentary lifestyle.

    Physical activity was measured using accelerometer GT3X+ Actigraph for 7 days continuously. The main measurement result was duration of physical activity. A wear time of ≥480 minutes/day was used as the criterion for a valid day, and ≥4 days (at least 3 weekdays and 1 weekend) were used as the criteria for a valid 7-day period of accumulated data.The cut-points for classify physical activity intensity levels are different, thus this will be specifically described in subsequent articles.

    Measured: 2017.01-2026.12

  6. Corsi block-tapping task

    Three accuracy measures were registered: The number of blocks of the longest correct sequence, the total number of correctly reproduced sequences, and the product of these two measures.

    Measured: 2017.01-2026.12

  7. Stroop task

    Response accuracy and reaction time(RT) were collected to assess behavioral performance.

    Measured: 2017.01-2026.12

  8. Wisconsin Card Sorting Test(WCST)

    Children with poor executive function exhibited a higher error rate and slower reaction times.

    Measured: 2017.01-2026.12

  9. Combined Raven's Test

    The correct number of questions is calculated to reflect intelligence level.(Level 1: a test standard score of high intelligence equal to or greater than 95% of the constant module of the same age.Level 2: good intelligence is between 75% and 95%.Level 3:average intelligence is between 25% and 75%. Level 4:the low level of intelligence is between 5% and 25%.Level 5: mental retardation is less than 5%)

    Measured: 2017.01-2026.12

  10. Event-related potentials

    Assessing cognition using the Event-Related Potentials (ERPs) methodology of certain early and late ERPs (i.e. P1, N1, N2, P2, P3).EEG activity was collected during the cognitive tasks from 64 electrode sites to derive and assess separately the ERPs amplitude and latency measures.

    Measured: 2018.09-2026.12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2018
  2. Study start1 Jan 2017
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03582709
Sponsor's protocol ID
8167120522
Status last verified
Jun 2018
First submitted
31 May 2018
Last updated
11 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lv Y, Cai L, Zeng X, Gui Z, Lai L, Tan W, Chen Y. Association between weekend catch-up sleep and executive functions in Chinese school-aged children. J Clin Sleep Med. 2020 Aug 15;16(8):1285-1293. doi: 10.5664/jcsm.8494.

    PubMed 32279704
  • Lv Y, Cai L, Gui Z, Zeng X, Tan M, Wan N, Lai L, Lu S, Tan W, Chen Y. Effects of physical activity and sedentary behaviour on cardiometabolic risk factors and cognitive function in children: protocol for a cohort study. BMJ Open. 2019 Oct 31;9(10):e030322. doi: 10.1136/bmjopen-2019-030322.

    PubMed 31676650

Questions about this trial

What is this clinical trial studying?

An observational study of Sedentary Behavior;Cognition;Cardiovascular-related Disease, run by CHEN Yajun.

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 3 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: enrolling by invitation, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-reported physical activity and sedentary lifestyle. (time frame: 2017.01-2026.12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03582709, which also lists 2 linked publications.

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 11 Jul 2018.

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