Clinical trial NCT05482191: Healthy Weight Management Project for Overweight and Obesity Children
Official title: Healthy Weight Management Project for Overweight and Obesity Children in Ningbo City
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Lead sponsor: Ningbo No. 1 Hospital
Sponsor class: OTHER
Collaborators: name: Peking University
First posted: 2022-08-01
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: change in body mass index (BMI)
timeFrame: 3 months，9 months , 24 months and 36 months
measure: change in controlled attenuation parameters (CAP)
timeFrame: 3 months，9 months , 24 months and 36 months
measure: Change in liver stiffness measurement (LSM)
timeFrame: 3 months，9 months , 24 months and 36 months
Secondary outcomes:
measure: Change in BMI z- score
timeFrame: 3 months，9 months , 24 months and 36 months
measure: change in blood glucose
timeFrame: 9 months
measure: change in blood lipids
timeFrame: 9 months
measure: change in fasting insulin
timeFrame: 9 months
measure: change in body fat percentage
timeFrame: 3 months and 9 months
measure: change in waist circumference
timeFrame: 3 months，9 months , 24 months and 36 months
measure: change in weight
timeFrame: 3 months，9 months , 24 months and 36 months
measure: change in cardiorespiratory endurance test
timeFrame: 3 months，9 months , 24 months and 36 months
measure: change in ALT(alanine transaminase)
timeFrame: 9 months
Other outcomes:
Locations:
city: Ningbo
country: China
facility: Ningbo First Hospital
Study officials:
References: