Clinical trial NCT02773823: A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren
Official title: A Comprehensive Intervention Study on Klotho Gene Methylation and Cardiovascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: obesity
children
cardiovascular health
intervention study
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 190
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

* Obese children; Aged 8-12 years old.

Exclusion Criteria:

* History of cardiovascular diseases and diabetes; Disability.

Primary outcomes:
measure: Body weight of study children
timeFrame: 8 months
measure: Body mass index of study children
timeFrame: 8 months
measure: Waist circumference of study children
timeFrame: 8 months
measure: Blood pressure
timeFrame: 8 months
measure: Blood lipids
timeFrame: 8 months
measure: Blood glucose
timeFrame: 8 months
measure: cardiorespiratory fitness of study children
timeFrame: 8 months
Secondary outcomes:
measure: Well-being of study children
timeFrame: 8 months
measure: Depression of study children
timeFrame: 8 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan university
state: Hubei
Study officials:
affiliation: Wuhan University
name: Qiqiang He, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1056/NEJMoa012512.
citation: 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.
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.
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