Optimizing Intervention Effects in Children and Adolescents

NCT ID: NCT05482165

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1627 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

The students of this group will receive multi-faceted intervention activities toward weight management.

Group Type: EXPERIMENTAL

Multi-faceted health promotion programme

Intervention Type: BEHAVIORAL

This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the intervention group will receive the following interventions:

• Develop and implement school policies related to weight loss
• Distribute health education materials on diet and exercise to students
• Carry out student health education courses

Usual practice group

The students of this group will receive regular health education.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Multi-faceted health promotion programme

This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the intervention group will receive the following interventions:

• Develop and implement school policies related to weight loss
• Distribute health education materials on diet and exercise to students
• Carry out student health education courses

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ningbo First Hospital

Ningbo, , China

Countries

China

Other Identifiers

2021-R168

Identifier Type: -

Identifier Source: org_study_id