Healthy Weight Management Project for Overweight and Obesity Children

Healthy Weight Management Project for Overweight and Obesity Children 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. 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Lifestyle intervention

• Study Type: Interventional
• Enrollment (Estimated): 300
• 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 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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.	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.
No Intervention: Usual practice group; No intervention

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	3 months，9 months , 24 months and 36 months
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
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 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	3 months and 9 months
change in ALT(alanine transaminase)	caculated by terminal value minus baseline value	9 months
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
change in waist circumference	caculated by terminal value minus baseline value	3 months，9 months , 24 months and 36 months
change in weight	caculated by terminal value minus baseline value	3 months，9 months , 24 months and 36 months
change in cardiorespiratory endurance test	caculated by terminal value minus baseline value	3 months，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 (Estimated): December 31, 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): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: NBFH20220667

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
• product manufactured in and exported from the U.S.: No