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Optimizing Intervention Effects in Children and Adolescents

N

Ningbo No. 1 Hospital

Status

Active, not recruiting

Conditions

Childhood Obesity

Treatments

Behavioral: Multi-faceted health promotion programme

Study type

Interventional

Funder types

Other

Identifiers

NCT05482165
2021-R168

Details and patient eligibility

About

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.

Enrollment

1,800 estimated patients

Sex

All

Ages

8 to 10 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,800 participants in 2 patient groups

Intervention group
Experimental group
Description:
The students of this group will receive multi-faceted intervention activities toward weight management.
Treatment:
Behavioral: Multi-faceted health promotion programme
Usual practice group
No Intervention group
Description:
The students of this group will receive regular health education.

Trial contacts and locations

1

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Central trial contact

Pingping Zhang, Master; Li Li, Bachelor

Data sourced from clinicaltrials.gov

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