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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Sedentary Behavior;Cognition;Cardiovascular-related Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 12 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary school students aged 7 to 12 in Guangzhou

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2017.01-2026.12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2017.01-2026.12
Biochemical indicator	Fasting blood glucose,total cholesterol, triglycerides, high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C).	2017.01-2026.12
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.	2017.01-2026.12
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.	2017.01-2026.12
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.	2017.01-2026.12
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.	2017.01-2026.12
Stroop task	Response accuracy and reaction time(RT) were collected to assess behavioral performance.	2017.01-2026.12
Wisconsin Card Sorting Test(WCST)	Children with poor executive function exhibited a higher error rate and slower reaction times.	2017.01-2026.12
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%)	2017.01-2026.12
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.	2018.09-2026.12

Collaborators and Investigators

• Sponsor: CHEN Yajun

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: May 31, 2018
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): July 11, 2018
• Last Update Submitted That Met QC Criteria: June 27, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 8167120522

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No