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A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren

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ClinicalTrials.gov Identifier: NCT02773823
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Qiqiang He, Wuhan University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Behavioral: Intervention group Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Comprehensive Intervention Study on Klotho Gene Methylation and Cardiovascular Risk Factors
Study Start Date : November 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2017
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention

Lifestyle intervention includes diet instruction and exercise intervention:

  1. Diet instruction: The children were asked to increase fruit/vegetables consumption, reduce high fat food, etc.
  2. Exercise intervention: The children participated sports 60 min/day,5d/week for 8 months.
 Behavioral: Intervention group
Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.
No Intervention: Control
No intervention in the group with "control".


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obese children; Aged 8-12 years old.

Exclusion Criteria:

  • History of cardiovascular diseases and diabetes; Disability.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02773823


Locations
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China, Hubei
Wuhan university
Wuhan, Hubei, China, 430071
Sponsors and Collaborators
Wuhan University
Investigators
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Principal Investigator: Qiqiang He, PhD Wuhan University
More Information
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Publications:

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Responsible Party: Qiqiang He, Professor, Wuhan University
ClinicalTrials.gov Identifier: NCT02773823    
Other Study ID Numbers: 81372973
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Qiqiang He, Wuhan University:
obesity
children
cardiovascular health
intervention study
Additional relevant MeSH terms:
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Cardiovascular Diseases