Healthy Weight Management Project for Overweight and Obesity Children

Obesity Clinical Trial

Official title:

Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05482191
• Other study ID #: NBFH20220667
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Ningbo First Hospital	Ningbo

Sponsors (2)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital	Peking University

Country where clinical trial is conducted

China, 

Outcome

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