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Completed

NCT Number: NCT05527938

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

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.

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Key information

Conditions

NAFLD Body Weight Childhood Obesity Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Web

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Caixia Tian

Shaoxing, Zhejiang, 312000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

web-based intervention

Other
  • 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 outcomes

  1. 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) .

Secondary outcomes

  1. The change of aspartate aminotransferase

    Time frame: Change from Baseline aspartate aminotransferase at 48 weeks

    Second outcome is aspartate aminotransferase

  2. The change of liver imaging

    Time frame: Change from Baseline liver imaging at 48 weeks

    Third outcome is liver imaging

  3. The change of BMI

    Time frame: Change from Baseline BMI at 48 weeks

    Fourth outcome is BMI

  4. 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

  5. The change of quality of life

    Time frame: Change from Baseline quality of life at 48 weeks

    Sixth outcome is quality of life

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shaoxing Maternity and Child Health Care Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Sep 6, 2022
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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