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A Behavior Intervention Study on Cardiovascular Health Among Chinese Obese Schoolchildren

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02773823
Enrollment
190
Registered
2016-05-16
Start date
2015-11-30
Completion date
2017-06-30
Last updated
2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

Keywords

obesity, children, cardiovascular health, intervention study

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.

Interventions

BEHAVIORALIntervention group

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

Sponsors

Wuhan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Obese children; Aged 8-12 years old.

Exclusion criteria

* History of cardiovascular diseases and diabetes; Disability.

Design outcomes

Primary

MeasureTime frameDescription
cardiorespiratory fitness of study children8 monthsCardiorespiratory 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.
Blood lipids8 monthsBlood 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 glucose8 monthsBlood 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.
Body weight of study children8 monthsBody weight will be measured with light clothes using a scale to the nearest 0.1 kg.
Body mass index of study children8 monthsBody 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 children8 monthsWaist circumference will be measured using a tape around his or her bare abdomen to the nearest 0.1 cm.
Blood pressure8 monthsBlood 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.

Secondary

MeasureTime frameDescription
Depression of study children8 monthsThe Depression Self-Rating Scale for Children (DSRSC) will be used for screening depression in children.
Well-being of study children8 monthsWell-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,

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026