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

NCT05527938 | Completed

• 1 other identifier: ShaoxingMaternityChildHC
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

NAFLD; Web; Childhood Obesity

Keywords

NAFLD; obese children; web; education; protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The change of aspartate aminotransferase

  Change from Baseline aspartate aminotransferase at 48 weeks

• The change of liver imaging

  Change from Baseline liver imaging at 48 weeks

• The change of BMI

  Change from Baseline BMI at 48 weeks

• The change of waist-to-hip ratio

  Change from Baseline waist-to-hip ratio at 48 weeks

• The change of quality of life

  Change from Baseline quality of life at 48 weeks

Other Outcomes (1)

• socio-demographic characteristics such as age, gender and ethnicity

  baseline

Study Arms (2)

web-based intervention

EXPERIMENTAL

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

the control group

NO INTERVENTION

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.

Interventions

web-based intervention OTHER

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.

web-based intervention

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The clinical diagnosis of Nonalcoholic Fatty Liver Disease

You may not qualify if:

• Patients do not agree to participate
• participate in other health intervention programs now

Sponsors & Collaborators

• Shaoxing Maternity and Child Health Care Hospital: lead

Study Sites (1)

Caixia Tian

Shaoxing, Zhejiang, 312000, China

Location

Related Publications (1)

• 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.

  PMID: 36339187 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Pediatric Obesity

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Caixia Tian, MSc

  Shaoxing Maternity and Child Health Care Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacist

Model Details: web-based intervention

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 6, 2022
• Study Start: September 30, 2022
• Primary Completion: December 31, 2022
• Study Completion: August 31, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

CN (1)