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

27 juni 2018 bijgewerkt door: CHEN Yajun
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.

Studie Overzicht

Toestand

Aanmelden op uitnodiging

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Verwacht)

1000

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

7 jaar tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

NVT

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Primary school students aged 7 to 12 in Guangzhou

Beschrijving

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Self-reported physical activity and sedentary lifestyle.
Tijdsspanne: 2017.01-2026.12
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.
2017.01-2026.12

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Anthropometric
Tijdsspanne: 2017.01-2026.12
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.
2017.01-2026.12
Biochemical indicator
Tijdsspanne: 2017.01-2026.12
Fasting blood glucose,total cholesterol, triglycerides, high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C).
2017.01-2026.12
Cardiorespiratory Fitness(CRF)
Tijdsspanne: 2017.01-2026.12
CRF was assessed by the 20-m shuttle run test.Estimations of submaximal oxygen consumption (VO2max) were obtained using Leger's formulae.
2017.01-2026.12
Self-reported cognition
Tijdsspanne: 2017.01-2026.12
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.
2017.01-2026.12
Objective measurement of physical activity and sedentary lifestyle.
Tijdsspanne: 2017.01-2026.12
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.
2017.01-2026.12
Corsi block-tapping task
Tijdsspanne: 2017.01-2026.12
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.
2017.01-2026.12
Stroop task
Tijdsspanne: 2017.01-2026.12
Response accuracy and reaction time(RT) were collected to assess behavioral performance.
2017.01-2026.12
Wisconsin Card Sorting Test(WCST)
Tijdsspanne: 2017.01-2026.12
Children with poor executive function exhibited a higher error rate and slower reaction times.
2017.01-2026.12
Combined Raven's Test
Tijdsspanne: 2017.01-2026.12
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%)
2017.01-2026.12
Event-related potentials
Tijdsspanne: 2018.09-2026.12
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.
2018.09-2026.12

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

CHEN Yajun

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2017

Primaire voltooiing (Verwacht)

31 december 2026

Studie voltooiing (Verwacht)

31 december 2026

Studieregistratiedata

Eerst ingediend

31 mei 2018

Eerst ingediend dat voldeed aan de QC-criteria

27 juni 2018

Eerst geplaatst (Werkelijk)

11 juli 2018

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 juli 2018

Laatste update ingediend die voldeed aan QC-criteria

27 juni 2018

Laatst geverifieerd

1 juni 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 8167120522

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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