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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05482191
Other study ID # NBFH20220667
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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