A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren
|ClinicalTrials.gov Identifier: NCT02773823|
Recruitment Status : Completed
First Posted : May 16, 2016
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases||Behavioral: Intervention group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||190 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Intervention
Lifestyle intervention includes diet instruction and exercise intervention:
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".
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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.
- 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,
- Depression of study children [ Time Frame: 8 months ]The Depression Self-Rating Scale for Children (DSRSC) will be used for screening depression in children.
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
|Wuhan, Hubei, China, 430071|
|Principal Investigator:||Qiqiang He, PhD||Wuhan University|