Prospective Cohort Study on Cognition and Cardiovascular Disease of Sedentary Behaviors in Children
27. června 2018 aktualizováno: 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.
Přehled studie
Postavení
Zápis na pozvánku
Detailní popis
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.
Typ studie
Pozorovací
Zápis (Očekávaný)
1000
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
7 let až 12 let (Dítě)
Přijímá zdravé dobrovolníky
N/A
Pohlaví způsobilá ke studiu
Všechno
Metoda odběru vzorků
Vzorek nepravděpodobnosti
Studijní populace
Primary school students aged 7 to 12 in Guangzhou
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Self-reported physical activity and sedentary lifestyle.
Časové okno: 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.
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2017.01-2026.12
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Anthropometric
Časové okno: 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
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Biochemical indicator
Časové okno: 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)
Časové okno: 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.
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2017.01-2026.12
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Self-reported cognition
Časové okno: 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.
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2017.01-2026.12
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Objective measurement of physical activity and sedentary lifestyle.
Časové okno: 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.
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2017.01-2026.12
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Corsi block-tapping task
Časové okno: 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.
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2017.01-2026.12
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Stroop task
Časové okno: 2017.01-2026.12
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Response accuracy and reaction time(RT) were collected to assess behavioral performance.
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2017.01-2026.12
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Wisconsin Card Sorting Test(WCST)
Časové okno: 2017.01-2026.12
|
Children with poor executive function exhibited a higher error rate and slower reaction times.
|
2017.01-2026.12
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Combined Raven's Test
Časové okno: 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%)
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2017.01-2026.12
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Event-related potentials
Časové okno: 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.
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2018.09-2026.12
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
1. ledna 2017
Primární dokončení (Očekávaný)
31. prosince 2026
Dokončení studie (Očekávaný)
31. prosince 2026
Termíny zápisu do studia
První předloženo
31. května 2018
První předloženo, které splnilo kritéria kontroly kvality
27. června 2018
První zveřejněno (Aktuální)
11. července 2018
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
11. července 2018
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
27. června 2018
Naposledy ověřeno
1. června 2018
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 8167120522
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