Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children

Not Applicable

Completed

• Conditions: Childhood Obesity; NAFLD; Web
• Interventions: Other: web-based intervention

• Registration Number: NCT05527938
• Lead Sponsor: Shaoxing Maternity and Child Health Care Hospital

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.

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-01
• Study First Posted: 2022-09-06
• Study Start: 2022-09-30
• Primary Completion: 2022-12-31
• Study Completion: 2023-08-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
web-based intervention	web-based intervention	1. Establishing management teams. 2. Establishment of a nursing intervention team. 3. Daily uploading of health intervention records 4. Regularly delivering related health knowledge. 5. Home visiting 6. Psychological guidance.

Primary Outcome Measures

Name	Time	Method
The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT）	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 Outcome Measures

Name	Time	Method
The change of BMI	Change from Baseline BMI at 48 weeks	Fourth outcome is BMI
The change of waist-to-hip ratio	Change from Baseline waist-to-hip ratio at 48 weeks	Fifth outcome is waist-to-hip ratio
The change of quality of life	Change from Baseline quality of life at 48 weeks	Sixth outcome is quality of life
The change of aspartate aminotransferase	Change from Baseline aspartate aminotransferase at 48 weeks	Second outcome is aspartate aminotransferase
The change of liver imaging	Change from Baseline liver imaging at 48 weeks	Third outcome is liver imaging

Trial Locations

Locations (1)

Caixia Tian; 🇨🇳 Shaoxing, Zhejiang, China