Optimizing Intervention Effects in Children and Adolescents

NCT05482165 | Active Not Recruiting

• 1 other identifier: 2021-R168
• Study Type: interventional
• Target: 1,627
• 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. 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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• change in BMI z- score

  9months , 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

  9 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The students of this group will receive multi-faceted intervention activities toward weight management.

Behavioral: Multi-faceted health promotion programme

Usual practice group

NO INTERVENTION

The students of this group will receive regular health education.

Interventions

Multi-faceted health promotion programme 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 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

Intervention 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 to 10 years old.

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

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; 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: PREVENTION
• 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)