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Healthy Weight Management Project for Overweight and Obesity Children

N

Ningbo No. 1 Hospital

Status

Active, not recruiting

Conditions

Obesity

Treatments

Behavioral: Lifestyle intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05482191
NBFH20220667

Details and patient eligibility

About

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.

Enrollment

331 patients

Sex

All

Ages

8 to 10 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

331 participants in 2 patient groups

Treatment group
Experimental group
Description:
Treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.
Treatment:
Behavioral: Lifestyle intervention
Usual practice group
No Intervention group
Description:
No intervention

Trial contacts and locations

1

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Central trial contact

Pingping Zhang, Master; Li Li, Bachelor

Data sourced from clinicaltrials.gov

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