Optimizing Intervention Effects in Children and Adolescents

Optimizing Intervention Effects in Children and Adolescents in Ningbo City

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Multi-faceted health promotion programme

• Study Type: Interventional
• Enrollment (Actual): 1627
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Ningbo, China
    • Ningbo First Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; The students of this group will receive multi-faceted intervention activities toward weight management.	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
No Intervention: Usual practice group; The students of this group will receive regular health education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in blood glucose	caculated by terminal value minus baseline value	9 months
change in blood lipids	include TC, TG, LDL-C, HDL-C; caculated by terminal value minus baseline value	9 months
change in fasting insulin	caculated by terminal value minus baseline value	9 months
change in body fat percentage	caculated by terminal value minus baseline value	9 months
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
change in waist circumference	caculated by terminal value minus baseline value	9 months, 24 months and 36 months
change in weight	caculated by terminal value minus baseline value	9months, 24 months and 36 months
change in cardiorespiratory endurance test	caculated by terminal value minus baseline value	9 months, 24 months and 36 months

Collaborators and Investigators

• Sponsor: Ningbo No. 1 Hospital
• Collaborators: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): June 25, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): August 1, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 4, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pediatric Obesity
• Other Study ID Numbers: 2021-R168

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No