Childhood Obesity, NAFLD, Web
Conditions
Keywords
NAFLD, obese children, web, education, protocol
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.
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.
Interventions
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.
Sponsors
Shaoxing Maternity and Child Health Care Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
web-based intervention
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of alanine aminotransferase（ALT）and gamma-glutamyl transferase（GGT） | 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
| Measure | Time frame | Description |
|---|---|---|
| The change of aspartate aminotransferase | Change from Baseline aspartate aminotransferase at 48 weeks | Second outcome is aspartate aminotransferase |
| The change of liver imaging | Change from Baseline liver imaging at 48 weeks | Third outcome is liver imaging |
| The change of waist-to-hip ratio | Change from Baseline waist-to-hip ratio at 48 weeks | Fifth outcome is waist-to-hip ratio |
| The change of quality of life | Change from Baseline quality of life at 48 weeks | Sixth outcome is quality of life |
| The change of BMI | Change from Baseline BMI at 48 weeks | Fourth outcome is BMI |
Other
| Measure | Time frame | Description |
|---|---|---|
| socio-demographic characteristics such as age, gender and ethnicity | baseline | In addition, socio-demographic characteristics such as age, gender and ethnicity will be recorded. |
Countries
China
Outcome results
None listed