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

NCT ID: NCT05527938

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-30

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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NAFLD Web Childhood Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

web-based intervention
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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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.

Group Type EXPERIMENTAL

web-based intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaoxing Maternity and Child Health Care Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Renjie

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caixia Tian, MSc

Role: PRINCIPAL_INVESTIGATOR

Shaoxing Maternity and Child Health Care Hospital

Locations

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Caixia Tian

Shaoxing, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 36339187 (View on PubMed)

Other Identifiers

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ShaoxingMaternityChildHC

Identifier Type: -

Identifier Source: org_study_id

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