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

October 11, 2023 updated by: Xu Renjie, Shaoxing Maternity and Child Health Care Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

85

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Shaoxing, Zhejiang, China, 312000
        • Caixia Tian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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. 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.
No Intervention: the control group

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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT）
Time Frame: 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) .
Change from Baseline ALT and GGT at 48 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
socio-demographic characteristics such as age, gender and ethnicity
Time Frame: baseline
In addition, socio-demographic characteristics such as age, gender and ethnicity will be recorded.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaoxing Maternity and Child Health Care Hospital

Investigators

  • Principal Investigator: Caixia Tian, MSc, Shaoxing Maternity and Child Health Care Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2022

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

August 31, 2023

Study Registration Dates

First Submitted

August 30, 2022

First Submitted That Met QC Criteria

September 1, 2022

First Posted (Actual)

September 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShaoxingMaternityChildHC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Childhood Obesity

Clinical Trials on web-based intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe