Healthy Weight Management Project for Overweight and Obesity Children

Not Applicable

Active, not recruiting

• Conditions: Obesity
• Interventions: Behavioral: Lifestyle intervention

• Registration Number: NCT05482191
• 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-28
• Study First Submitted QC: 2022-07-28
• Study First Posted: 2022-08-01
• Study Start: 2022-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-23
• Last Update Posted: 2023-10-24
• Primary Completion: 2023-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Lifestyle intervention	Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.

Primary Outcome Measures

Name	Time	Method
change in controlled attenuation parameters (CAP)	3 months，9 months , 24 months and 36 months	* CAP will be detected by Fibroscan; * caculated by terminal value minus baseline value
Change in liver stiffness measurement (LSM)	3 months，9 months , 24 months and 36 months	* LSM will be detected by Fibroscan; * caculated by terminal value minus baseline value
change in body mass index (BMI)	3 months，9 months , 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

Name	Time	Method
change in fasting insulin	9 months	caculated by terminal value minus baseline value
change in body fat percentage	3 months and 9 months	caculated by terminal value minus baseline value
change in blood glucose	9 months	caculated by terminal value minus baseline value
Change in BMI z- score	3 months，9 months , 24 months and 36 months	* BMI z- score are measures of relative weight adjusted for child age and sex; * caculated by terminal value minus baseline value
change in blood lipids	9 months	* include TC, TG, LDL-C, HDL-C; * caculated by terminal value minus baseline value
change in waist circumference	3 months，9 months , 24 months and 36 months	caculated by terminal value minus baseline value
change in weight	3 months，9 months , 24 months and 36 months	caculated by terminal value minus baseline value
change in ALT(alanine transaminase)	9 months	caculated by terminal value minus baseline value
change in cardiorespiratory endurance test	3 months，9 months , 24 months and 36 months	caculated by terminal value minus baseline value

Trial Locations

Locations (1)

Ningbo First Hospital; 🇨🇳 Ningbo, China