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NCT Number: NCT05482191

Healthy Weight Management Project for Overweight and Obesity Children

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo First Hospital

Ningbo, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifestyle Intervention

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 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.

Primary outcomes

  1. change in body mass index (BMI)

    Time frame: 3 months，9 months , 24 months and 36 months

    • weight and height will be combined to report BMI in kg/m^2
    • caculated by terminal value minus baseline value

  2. change in controlled attenuation parameters (CAP)

    Time frame: 3 months，9 months , 24 months and 36 months

    • CAP will be detected by Fibroscan
    • caculated by terminal value minus baseline value

  3. Change in liver stiffness measurement (LSM)

    Time frame: 3 months，9 months , 24 months and 36 months

    • LSM will be detected by Fibroscan
    • caculated by terminal value minus baseline value

Secondary outcomes

  1. Change in BMI z- score

    Time frame: 3 months，9 months , 24 months and 36 months

    • BMI z- score are measures of relative weight adjusted for child age and sex
    • caculated by terminal value minus baseline value

  2. change in blood glucose

    Time frame: 9 months

    caculated by terminal value minus baseline value

  3. change in blood lipids

    Time frame: 9 months

    • include TC, TG, LDL-C, HDL-C
    • caculated by terminal value minus baseline value

  4. change in fasting insulin

    Time frame: 9 months

    caculated by terminal value minus baseline value

  5. change in body fat percentage

    Time frame: 3 months and 9 months

    caculated by terminal value minus baseline value

  6. change in waist circumference

    Time frame: 3 months，9 months , 24 months and 36 months

    caculated by terminal value minus baseline value

  7. change in weight

    Time frame: 3 months，9 months , 24 months and 36 months

    caculated by terminal value minus baseline value

  8. change in cardiorespiratory endurance test

    Time frame: 3 months，9 months , 24 months and 36 months

    caculated by terminal value minus baseline value

  9. change in ALT(alanine transaminase)

    Time frame: 9 months

    caculated by terminal value minus baseline value

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Collaborators

  • Peking University

Registry information

Official study title

Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Aug 1, 2022
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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