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Optimizing Intervention Effects in Children and Adolescents

Not Applicable
Active, not recruiting
Conditions
Childhood Obesity
Interventions
Behavioral: Multi-faceted health promotion programme
Registration Number
NCT05482165
Lead Sponsor
Ningbo No. 1 Hospital
Brief Summary

Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term.

This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention.

The project will be carried out in six primary schools in Ningbo City, Zhejiang Province , those schools are randomly divided into two groups: the intervention group and the usual practice group. The participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. This intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1800
Inclusion Criteria
  • Parents agree and support their children's weight loss, and students and parents have informed consent;
  • Students in third grade aged 8 to 10 years old.
Exclusion Criteria
  • medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis;
  • obesity caused by endocrine diseases or side effects of drugs;
  • abnormal physical development like dwarfism or gigantism;
  • physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;
  • inability to participate in school sport activities;
  • a loss in weight by vomiting or taking drugs during the past 3 months.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention groupMulti-faceted health promotion programmeThe students of this group will receive multi-faceted intervention activities toward weight management.
Primary Outcome Measures
NameTimeMethod
change in body mass index (BMI)9months , 24 months and 36 months

* weight and height will be combined to report BMI in kg/m\^2

* caculated by terminal value minus baseline value

Secondary Outcome Measures
NameTimeMethod
change in cardiorespiratory endurance test9 months, 24 months and 36 months

caculated by terminal value minus baseline value

change in BMI z- score9months , 24 months and 36 months

* measures of relative weight adjusted for child age and sex

* caculated by terminal value minus baseline value

change in blood glucose9 months

caculated by terminal value minus baseline value

change in body fat percentage9 months

caculated by terminal value minus baseline value

change in weight9months, 24 months and 36 months

caculated by terminal value minus baseline value

change in blood lipids9 months

* include TC, TG, LDL-C, HDL-C

* caculated by terminal value minus baseline value

change in fasting insulin9 months

caculated by terminal value minus baseline value

change in waist circumference9 months, 24 months and 36 months

caculated by terminal value minus baseline value

Trial Locations

Locations (1)

Ningbo First Hospital

🇨🇳

Ningbo, China

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