The Effectiveness of Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children: A Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- NAFLD
- Sponsor
- Shaoxing Maternity and Child Health Care Hospital
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT）
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The web-based continuity of care intervention model to provide comprehensive nursing interventions for obese children with NAFLD, always tracking their performance status, enabling them to grasp the knowledge of healthy weight loss, develop good lifestyle habits, and reduce their weight, thus reducing the incidence of NAFLD in children.
Detailed Description
The web-based continuity of care intervention model to provide comprehensive nursing interventions for obese children with NAFLD, always tracking their performance status, enabling them to grasp the knowledge of healthy weight loss, develop good lifestyle habits, and reduce their weight, thus reducing the incidence of NAFLD in children.The primary outcome are serum biomarkers such as alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) . Second outcomes are: aspartate aminotransferase, and liver imaging (liver ultrasound and magnetic resonance imaging), BMI, waist-to-hip ratio and quality of life. In addition, socio-demographic characteristics such as age, gender and ethnicity will be recorded. All outcomes were measured at baseline, week 4, week 16, week 24, week 36, and week 48 to determine the trajectory of change in outcome variables over intervention process.
Investigators
Xu Renjie
Pharmacist
Shaoxing Maternity and Child Health Care Hospital
Eligibility Criteria
Inclusion Criteria
- •The clinical diagnosis of Nonalcoholic Fatty Liver Disease
Exclusion Criteria
- •Patients do not agree to participate
- •participate in other health intervention programs now
Outcomes
Primary Outcomes
The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT）
Time Frame: Change from Baseline ALT and GGT at 48 weeks
The primary outcome are serum biomarkers such as alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) .
Secondary Outcomes
- The change of BMI(Change from Baseline BMI at 48 weeks)
- The change of waist-to-hip ratio(Change from Baseline waist-to-hip ratio at 48 weeks)
- The change of quality of life(Change from Baseline quality of life at 48 weeks)
- The change of aspartate aminotransferase(Change from Baseline aspartate aminotransferase at 48 weeks)
- The change of liver imaging(Change from Baseline liver imaging at 48 weeks)