Optimizing Intervention Effects in Children and Adolescents

Childhood Obesity Clinical Trial

Official title:

Optimizing Intervention Effects in Children and Adolescents in Ningbo City

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05482165
• Other study ID #: 2021-R168
• 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. Effective strategies to reduce childhood obesity prevalence may help to prevent related chronic diseases in the whole population in the long term. This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in preventing childhood overweight and obesity; (2) to determine the sustainability of the intervention in preventing overweight and obesity; and (3) to evaluate the process and health economics of the intervention. The project will be carried out in six primary schools in Ningbo City, Zhejiang Province , those schools are randomly divided into two groups: the intervention group and the usual practice group. The participants of the study were students in the third grade of primary school, and the intervention will last for one academic year. This intervention programme will target the influencing factors of childhood obesity at both individual (student-focused activities) and environmental levels (a supportive family and school environment), with the intent to influence the knowledge, attitude and behaviours of school children.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1800
• 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 to 10 years old.

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

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Multi-faceted health promotion programme
This intervention programme will target the influencing factors of childhood obesity to influence the knowledge, attitude and behaviours of school children. Students in the intervention 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

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	9months , 24 months and 36 months
Secondary	change in BMI z- score	measures of relative weight adjusted for child age and sex; caculated by terminal value minus baseline value	9months , 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	9 months
Secondary	change in waist circumference	caculated by terminal value minus baseline value	9 months, 24 months and 36 months
Secondary	change in weight	caculated by terminal value minus baseline value	9months, 24 months and 36 months
Secondary	change in cardiorespiratory endurance test	caculated by terminal value minus baseline value	9 months, 24 months and 36 months