Clinical trial NCT03582709: Prospective Cohort Study on Cognition and Cardiovascular Disease of Sedentary Behaviors in Children
Official title: Prospective Cohort Study on Cognition and Cardiovascular Disease of Sedentary Behaviors in Children
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Sedentary Behavior;Cognition;Cardiovascular-related Disease
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary school students aged 7 to 12 in Guangzhou

Brief 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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported physical activity and sedentary lifestyle.
timeFrame: 2017.01-2026.12
Secondary outcomes:
measure: Anthropometric
timeFrame: 2017.01-2026.12
measure: Biochemical indicator
timeFrame: 2017.01-2026.12
measure: Cardiorespiratory Fitness(CRF)
timeFrame: 2017.01-2026.12
measure: Self-reported cognition
timeFrame: 2017.01-2026.12
measure: Objective measurement of physical activity and sedentary lifestyle.
timeFrame: 2017.01-2026.12
measure: Corsi block-tapping task
timeFrame: 2017.01-2026.12
measure: Stroop task
timeFrame: 2017.01-2026.12
measure: Wisconsin Card Sorting Test(WCST)
timeFrame: 2017.01-2026.12
measure: Combined Raven's Test
timeFrame: 2017.01-2026.12
measure: Event-related potentials
timeFrame: 2018.09-2026.12
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.