A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effects of comprehensive behavior on cardiovascular health among obese schoolchildren. The intervention methods include dietary instruction and exercise intervention. The main outcomes are weight, body mass index, blood pressure, lipids and glucose.

Detailed Description
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Two public primary schools of a similar size were selected. They were allocated either to the intervention or control group. Children in Grade 4th and 5th in each school were invited to participate in the physical examination (height and weight measures).Obese children based on Chinese BMI cut-off points were included in this study.Children in the intervention group were encouraged to take healthy diet habits and increased their physical activity.After eight months healthy behavior intervention, Children's height, weight, waist, hip, blood pressure, cardiorespiratory fitness will be measured. Fasting blood will be taken to measure lipids and glucose levels.

Official Title
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A Comprehensive Intervention Study on Klotho Gene Methylation and Cardiovascular Risk Factors

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Behavioral: Intervention group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obese children; Aged 8-12 years old. Exclusion Criteria: History of cardiovascular diseases and diabetes; Disability.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Lifestyle intervention includes diet instruction and exercise intervention: Diet instruction: The children were asked to increase fruit/vegetables consumption, reduce high fat food, etc. Exercise intervention: The children participated sports 60 min/day,5d/week for 8 months. | Behavioral: Intervention group<br>* Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.<br>|
| No Intervention: Control<br>No intervention in the group with control. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight of study children | Body weight will be measured with light clothes using a scale to the nearest 0.1 kg. | 8 months | 
| Body mass index of study children | Body mass index is defined as the individual's body weight divided by the square of his or her height (height is measured using a non- stretchable tape suspended from the wall is recorded to the nearest 0.1 cm). | 8 months | 
| Waist circumference of study children | Waist circumference will be measured using a tape around his or her bare abdomen to the nearest 0.1 cm. | 8 months | 
| Blood pressure | Blood pressure will be measured three times by auscultation method with appropriate cuff size after 20 minutes of rest.The average of the blood pressure measurements is defined as hypertension if it was >95th percentile according to their age, gender and height percentile. | 8 months | 
| Blood lipids | Blood samples will be obtained in the morning by venipuncture after an overnight fast. Serum lipid profiles (total cholesterol ,triglycerides, low-density lipoprotein, high-density lipoprotein) will be measured using routine enzymatic methods. | 8 months | 
| Blood glucose | Blood samples is obtained in the morning by venipuncture after an overnight fast. The glucose oxidase method was used in the determination of blood glucose levels. | 8 months | 
| cardiorespiratory fitness of study children | Cardiorespiratory refers to the ability of the circulatory and respiratory systems to supply oxygen to skeletal muscles during sustained physical activity. It is measured by 20 meter shuttle-run test. | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being of study children | Well-being will be measured by The WHO 5-item Well-Being Index (WHO-5), which is a short screening instrument for the detection of depression in the general population, | 8 months | 
| Depression of study children | The Depression Self-Rating Scale for Children (DSRSC) will be used for screening depression in children. | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, children, cardiovascular health, intervention study