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Healthy Weight Management Project for Overweight and Obesity Children

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Enrollment target: estimated 300 to confirmed 331
    • Primary completion date changed from estimate of Dec 31, 2023 to Jun 25, 2023
    v7
  2. Minor Secondary endpoints: details revised at 4 of 9 entriesv6
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2023 to Dec 31, 2025
    • Secondary endpoints: details revised at 4 of 9 entries
    • Site details revised
    v5
  4. Minor Secondary endpoints: details revised at 9 of 9 entriesv4
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v3
  6. Notable Primary endpoints: 1 to 3
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 1 to 9
    • Study title shortened, about 1 word
    v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05482191
Lead Sponsor Ningbo No. 1 Hospital
Collaborators: Peking University
Conditions
(from sponsor)
Obesity
Related terms Obesity
Enrollment 331 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov