A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773823
• Other study ID #: 81372973
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2018
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Obese children; Aged 8-12 years old.

Exclusion Criteria:

• History of cardiovascular diseases and diabetes; Disability.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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

Locations

Country	Name	City	State
China	Wuhan university	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

References & Publications (5)

He QQ, Wong TW, Du L, Jiang ZQ, Yu TS, Qiu H, Gao Y, Liu WJ, Wu JG. Physical activity, cardiorespiratory fitness, and obesity among Chinese children. Prev Med. 2011 Feb;52(2):109-13. doi: 10.1016/j.ypmed.2010.11.005. Epub 2010 Nov 23. — View Citation

Hu FB, Manson JE, Stampfer MJ, Colditz G, Liu S, Solomon CG, Willett WC. Diet, lifestyle, and the risk of type 2 diabetes mellitus in women. N Engl J Med. 2001 Sep 13;345(11):790-7. — View Citation

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. — View Citation

Semba RD, Cappola AR, Sun K, Bandinelli S, Dalal M, Crasto C, Guralnik JM, Ferrucci L. Plasma klotho and cardiovascular disease in adults. J Am Geriatr Soc. 2011 Sep;59(9):1596-601. doi: 10.1111/j.1532-5415.2011.03558.x. Epub 2011 Aug 24. — View Citation

Thompson D, Markovitch D, Betts JA, Mazzatti D, Turner J, Tyrrell RM. Time course of changes in inflammatory markers during a 6-mo exercise intervention in sedentary middle-aged men: a randomized-controlled trial. J Appl Physiol (1985). 2010 Apr;108(4):769-79. doi: 10.1152/japplphysiol.00822.2009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight of study children	Body weight will be measured with light clothes using a scale to the nearest 0.1 kg.	8 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Depression of study children	The Depression Self-Rating Scale for Children (DSRSC) will be used for screening depression in children.	8 months