Clinical trial NCT05527938: Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
Official title: The Effectiveness of Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children: A Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Web
Childhood Obesity
Keywords: NAFLD
obese children
web
education
protocol
Lead sponsor: Shaoxing Maternity and Child Health Care Hospital
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 85
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: web-based intervention
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT）
timeFrame: Change from Baseline ALT and GGT at 48 weeks
Secondary outcomes:
measure: The change of aspartate aminotransferase
timeFrame: Change from Baseline aspartate aminotransferase at 48 weeks
measure: The change of liver imaging
timeFrame: Change from Baseline liver imaging at 48 weeks
measure: The change of BMI
timeFrame: Change from Baseline BMI at 48 weeks
measure: The change of waist-to-hip ratio
timeFrame: Change from Baseline waist-to-hip ratio at 48 weeks
measure: The change of quality of life
timeFrame: Change from Baseline quality of life at 48 weeks
Other outcomes:
measure: socio-demographic characteristics such as age, gender and ethnicity
timeFrame: baseline
Locations:
city: Shaoxing
country: China
facility: Caixia Tian
state: Zhejiang
Study officials:
affiliation: Shaoxing Maternity and Child Health Care Hospital
name: Caixia Tian, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tian C, Xu J, Wang G, Yu L, Tang X. The effectiveness of web-based interventions on non-alcoholic fatty liver disease (NAFLD) in obese children: A study protocol for a randomized controlled trial. Front Public Health. 2022 Oct 20;10:930901. doi: 10.3389/fpubh.2022.930901. eCollection 2022.