Healthy Weight Management Project for Overweight and Obesity Children

NCT05482191 | Active Not Recruiting

• 1 other identifier: NBFH20220667
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• change in body mass index (BMI)

  * weight and height will be combined to report BMI in kg/m\^2 * caculated by terminal value minus baseline value

  3 months，9 months , 24 months and 36 months

• change in controlled attenuation parameters (CAP)

  * CAP will be detected by Fibroscan * caculated by terminal value minus baseline value

  3 months，9 months , 24 months and 36 months

• Change in liver stiffness measurement (LSM)

  * LSM will be detected by Fibroscan * caculated by terminal value minus baseline value

  3 months，9 months , 24 months and 36 months

Secondary Outcomes (9)

• Change in BMI z- score

  3 months，9 months , 24 months and 36 months

• change in blood glucose

  9 months

• change in blood lipids

  9 months

• change in fasting insulin

  9 months

• change in body fat percentage

  3 months and 9 months

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Behavioral: Lifestyle intervention

Usual practice group

NO INTERVENTION

No intervention

Interventions

Lifestyle intervention 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.

Treatment group

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead
• Peking University: collaborator

Study Sites (1)

Ningbo First Hospital

Ningbo, China

Location

Related Publications (1)

• 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.

  PMID: 38504343 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 1, 2022
• Study Start: September 1, 2022
• Primary Completion: June 25, 2023
• Study Completion: December 31, 2025
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)