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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effectiveness of Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children: A Study Protocol for a Randomized Controlled Trial

Conditions
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NAFLD, Web, Childhood Obesity

Intervention / Treatment
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* Other: web-based intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: web-based intervention
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: web-based intervention<br>Establishing management teams. Establishment of a nursing intervention team. Daily uploading of health intervention records Regularly delivering related health knowledge. Home visiting Psychological guidance. | Other: web-based intervention<br>* Establishing management teams. Establishment of a nursing intervention team. Daily uploading of health intervention records Regularly delivering related health knowledge. Home visiting Psychological guidance. The health teachers in the team should closely understand the psychological trends of the patients during the telephone follow-up and home visits and verbally communicate more with the children to stimulate them to develop good living habits and increase their confidence in healing.<br>|
| No Intervention: the control group<br>1. Routine care.At each visit to the hospital, in this time, the child and his parents are given health education on diet and exercise booklets, and the parents supervise the child's daily life. The team members will review the child's condition every month for feedback. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT） | The primary outcome are serum biomarkers such as alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) . | Change from Baseline ALT and GGT at 48 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAFLD, obese children, web, education, protocol