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

Childhood Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05527938
• Other study ID #: ShaoxingMaternityChildHC
• Status: Completed
• Phase: N/A
• Start date: September 30, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: October 2023
• Source: Shaoxing Maternity and Child Health Care Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: August 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Fatty Liver
• Liver Diseases
• NAFLD
• Non-alcoholic Fatty Liver Disease
• Pediatric Obesity
• Web

Intervention

Other:
• web-based intervention
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.

Locations

Country	Name	City	State
China	Caixia Tian	Shaoxing	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shaoxing Maternity and Child Health Care Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	socio-demographic characteristics such as age, gender and ethnicity	In addition, socio-demographic characteristics such as age, gender and ethnicity will be recorded.	baseline
Primary	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	The change of aspartate aminotransferase	Second outcome is aspartate aminotransferase	Change from Baseline aspartate aminotransferase at 48 weeks
Secondary	The change of liver imaging	Third outcome is liver imaging	Change from Baseline liver imaging at 48 weeks
Secondary	The change of BMI	Fourth outcome is BMI	Change from Baseline BMI at 48 weeks
Secondary	The change of waist-to-hip ratio	Fifth outcome is waist-to-hip ratio	Change from Baseline waist-to-hip ratio at 48 weeks
Secondary	The change of quality of life	Sixth outcome is quality of life	Change from Baseline quality of life at 48 weeks