Healthy Weight Management Project for Overweight and Obesity Children

NCT ID: NCT05482191

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 331 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. Nonalcoholic fatty liver disease (NAFLD) is tightly associated with obesity, in China, the prevalence of NAFLD in obesity children is 40.0%，the main interventions for NAFLD are lifestyle interventions. Effective strategies to helping students lose weight and alleviate NAFLD through lifestyle interventions may help promote the physical and mental health of obese students.

This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in treating childhood overweight and obesity; (2) to determine the sustainability of the treatment in preventing overweight and obesity; (3) to help alleviate or reverse NAFLD in obesity children.

Children with overweight and obesity in six primary schools in Ningbo City, Zhejiang Province will be seleted and randomly divided into two groups: the treatment group and the usual practice group. The participants of the study were students in the third grade of primary school, and the treatment will last for one academic year. This treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.

Conditions

Obesity

Study Design

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

Study Groups

Treatment group

Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.

Group Type: EXPERIMENTAL

Lifestyle intervention

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 treatment 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
• Diet and exercise instruction by professional nutritionist using internet applet
• Take part in sports activities that are organized by the sports health teacher during school hours.

Usual practice group

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lifestyle intervention

This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the treatment 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
• Diet and exercise instruction by professional nutritionist using internet applet
• Take part in sports activities that are organized by the sports health teacher during school hours.

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 and 10 years old;
• students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents.

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

References

Zhang PP, Wang YX, Shen FJ, Xing YF, Gu JY, Li XY, Jin H, Jin SF, Xu M, Wang HJ, Wang H, Li L. Lifestyle intervention in children with obesity and nonalcoholic fatty liver disease (NAFLD): study protocol for a randomized controlled trial in Ningbo city (the SCIENT study). Trials. 2024 Mar 20;25(1):196. doi: 10.1186/s13063-024-08046-4.

Reference Type: DERIVED

PMID: 38504343 (View on PubMed)

Other Identifiers

NBFH20220667

Identifier Type: -

Identifier Source: org_study_id