Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
Primary Purpose
NAFLD, Web, Childhood Obesity
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
web-based intervention
Sponsored by
About this trial
This is an interventional supportive care trial for NAFLD focused on measuring NAFLD, obese children, web, education, protocol
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
Sites / Locations
- Caixia Tian
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
web-based intervention
the control group
Arm Description
Establishing management teams. Establishment of a nursing intervention team. Daily uploading of health intervention records Regularly delivering related health knowledge. Home visiting Psychological guidance.
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.
Outcomes
Primary Outcome Measures
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) .
Secondary Outcome Measures
The change of aspartate aminotransferase
Second outcome is aspartate aminotransferase
The change of liver imaging
Third outcome is liver imaging
The change of BMI
Fourth outcome is BMI
The change of waist-to-hip ratio
Fifth outcome is waist-to-hip ratio
The change of quality of life
Sixth outcome is quality of life
Full Information
NCT ID
NCT05527938
First Posted
August 30, 2022
Last Updated
October 11, 2023
Sponsor
Shaoxing Maternity and Child Health Care Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05527938
Brief Title
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
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
August 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shaoxing Maternity and Child Health Care Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD, Web, Childhood Obesity
Keywords
NAFLD, obese children, web, education, protocol
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
web-based intervention
Masking
Participant
Masking Description
Study personnel involved in the data assessment of the study are blinded to the patients' treatment assignment. The clinical doctors that deliver the study treatment are not blinded and are therefore uninvolved in the patients' data assessments related to this study. Data analysts are blinded to group allocation.
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
web-based intervention
Arm Type
Experimental
Arm Description
Establishing management teams.
Establishment of a nursing intervention team.
Daily uploading of health intervention records
Regularly delivering related health knowledge.
Home visiting
Psychological guidance.
Arm Title
the control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
web-based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of alanine aminotransferase(ALT)and gamma-glutamyl transferase(GGT)
Description
The primary outcome are serum biomarkers such as alanine aminotransferase (ALT) and gamma-glutamyl transferase (GGT) .
Time Frame
Change from Baseline ALT and GGT at 48 weeks
Secondary Outcome Measure Information:
Title
The change of aspartate aminotransferase
Description
Second outcome is aspartate aminotransferase
Time Frame
Change from Baseline aspartate aminotransferase at 48 weeks
Title
The change of liver imaging
Description
Third outcome is liver imaging
Time Frame
Change from Baseline liver imaging at 48 weeks
Title
The change of BMI
Description
Fourth outcome is BMI
Time Frame
Change from Baseline BMI at 48 weeks
Title
The change of waist-to-hip ratio
Description
Fifth outcome is waist-to-hip ratio
Time Frame
Change from Baseline waist-to-hip ratio at 48 weeks
Title
The change of quality of life
Description
Sixth outcome is quality of life
Time Frame
Change from Baseline quality of life at 48 weeks
Other Pre-specified Outcome Measures:
Title
socio-demographic characteristics such as age, gender and ethnicity
Description
In addition, socio-demographic characteristics such as age, gender and ethnicity will be recorded.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caixia Tian, MSc
Organizational Affiliation
Shaoxing Maternity and Child Health Care Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Caixia Tian
City
Shaoxing
State/Province
Zhejiang
ZIP/Postal Code
312000
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36339187
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.
Results Reference
derived
Learn more about this trial
Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
We'll reach out to this number within 24 hrs