NAFLDNCT05527938
Web-based Interventions on Nonalcoholic Fatty Liver Disease (NAFLD) in Obese Children
A study testing web-based intervention in people with NAFLD and Web, run by Shaoxing Maternity and Child Health Care Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- NAFLD, Web, Childhood Obesity
- What is being tested?
- web-based intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The clinical diagnosis of Nonalcoholic Fatty Liver Disease
Who cannot join
- Patients do not agree to participate
- participate in other health intervention programs now
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- NAFLD, Web, Childhood Obesity
- Being tested
- web-based intervention
- Keywords
- NAFLD, obese children, web, education, protocol
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based interventionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: Change from Baseline ALT and GGT at 48 weeks
Secondary outcomes (5)
The change of aspartate aminotransferase
Second outcome is aspartate aminotransferase
Measured: Change from Baseline aspartate aminotransferase at 48 weeks
The change of liver imaging
Third outcome is liver imaging
Measured: Change from Baseline liver imaging at 48 weeks
The change of BMI
Fourth outcome is BMI
Measured: Change from Baseline BMI at 48 weeks
The change of waist-to-hip ratio
Fifth outcome is waist-to-hip ratio
Measured: Change from Baseline waist-to-hip ratio at 48 weeks
The change of quality of life
Sixth outcome is quality of life
Measured: Change from Baseline quality of life at 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start30 Sep 2022
- Primary completion31 Dec 2022
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- web-based intervention
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaoxing Maternity and Child Health Care Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Renjie, Shaoxing Maternity and Child Health Care Hospital
- Investigators
- Caixia Tian, MSc, Principal investigator, Shaoxing Maternity and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05527938
- Sponsor's protocol ID
- ShaoxingMaternityChildHC
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36339187
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05527938
- Acronym / sponsor ID
- ShaoxingMaternityChildHC
- Conditions
- NAFLD, Web, Childhood Obesity
- Keywords
- NAFLD, obese children, web, education, protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Shaoxing Maternity and Child Health Care HospitalUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 6 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- web-based intervention
| Arm | Type | Receives |
|---|---|---|
| web-based intervention | Experimental | Other: web-based intervention1. 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 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. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- The clinical diagnosis of Nonalcoholic Fatty Liver Disease
Key exclusion criteria (2 listed)
- Patients do not agree to participate
- participate in other health intervention programs now
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based intervention1. 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. | Other | web-based intervention |
Primary outcome
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) .
5 secondary outcomes
The change of aspartate aminotransferase
Time frame: Change from Baseline aspartate aminotransferase at 48 weeks
The change of liver imaging
Time frame: Change from Baseline liver imaging at 48 weeks
The change of BMI
Time frame: 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
The change of quality of life
Time frame: Change from Baseline quality of life at 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Derived from this study: PubMed 36339187Tian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caixia Tian, MSc principal investigator
Shaoxing Maternity and Child Health Care Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based intervention in people with NAFLD and Web, run by Shaoxing Maternity and Child Health Care Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT） (time frame: Change from Baseline ALT and GGT at 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05527938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.