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

27 июня 2018 г. обновлено: 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.

Обзор исследования

Статус

Запись по приглашению

Условия

Sedentary Behavior;Cognition;Cardiovascular-related Disease

Подробное описание

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.

Тип исследования

Наблюдательный

Регистрация (Ожидаемый)

1000

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 7 лет до 12 лет (Ребенок)

Принимает здоровых добровольцев

Н/Д

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

Primary school students aged 7 to 12 in Guangzhou

Описание

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.

Учебный план

В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Наблюдательные модели: Когорта
Временные перспективы: Перспективный

Что измеряет исследование?

Первичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Self-reported physical activity and sedentary lifestyle. Временное ограничение: 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

Вторичные показатели результатов

Мера результата	Мера Описание	Временное ограничение
Anthropometric Временное ограничение: 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 Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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. Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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) Временное ограничение: 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 Временное ограничение: 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 Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

CHEN Yajun

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

1 января 2017 г.

Первичное завершение (Ожидаемый)

31 декабря 2026 г.

Завершение исследования (Ожидаемый)

31 декабря 2026 г.

Даты регистрации исследования

Первый отправленный

31 мая 2018 г.

Впервые представлено, что соответствует критериям контроля качества

27 июня 2018 г.

Первый опубликованный (Действительный)

11 июля 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)