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Completed

NCT Number: NCT02773823

A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren

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.

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Key information

Conditions

Cardiovascular Diseases Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wuhan university

Wuhan, Hubei, 430071, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obese children; Aged 8-12 years old.

Exclusion criteria

  • History of cardiovascular diseases and diabetes; Disability.

Treatment and study plan

Intervention Group

Behavioral

Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.

Primary outcomes

  1. Body weight of study children

    Time frame: 8 months

    Body weight will be measured with light clothes using a scale to the nearest 0.1 kg.

  2. Body mass index of study children

    Time frame: 8 months

    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).

  3. Waist circumference of study children

    Time frame: 8 months

    Waist circumference will be measured using a tape around his or her bare abdomen to the nearest 0.1 cm.

  4. Blood pressure

    Time frame: 8 months

    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.

  5. Blood lipids

    Time frame: 8 months

    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.

  6. Blood glucose

    Time frame: 8 months

    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.

  7. cardiorespiratory fitness of study children

    Time frame: 8 months

    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.

Secondary outcomes

  1. Well-being of study children

    Time frame: 8 months

    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,

  2. Depression of study children

    Time frame: 8 months

    The Depression Self-Rating Scale for Children (DSRSC) will be used for screening depression in children.

Sponsors and collaborators

Lead sponsor

Wuhan University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
May 16, 2016
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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