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A 48-week dietary intervention program was conducted in children aged 5-14 years with a diagnosis of NAFLD, who were randomized into a low free sugar diet group and a regular diet group. The primary objective of this study is to determine whether a low free sugar dietary intervention program improves liver function, fasting glucose, fasting insulin, lipid profile and hepatic steatosis in children with NAFLD. The effects of the intervention will be analyzed and compared at weeks 12, 24 and 48.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental |
| |
| Control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dietary intervention for low free sugars | Behavioral | After baseline data collection, the intervention group received a 30-60 minute educational session with a dietitian and clinicians, including a health education prescription. Interventions occurred at weeks 1, 12 and 24, with routine evaluations of disease, diet, physical activity, and adherence. Follow-ups at 48 weeks assessed NAFLD extent, dietary profile, and health knowledge for both subjects and guardians. |
| Measure | Description | Time Frame |
|---|---|---|
| NAFLD | NAFLD was diagnosed using liver ultrasonography with a Phillip IU Elite color Doppler ultrasound after a fasting period to reduce gastrointestinal interference. | At weeks 1, 12 and 24 |
| Dietary | The dietary habits of the subjects were evaluated by a semi-quantitative Food Frequency Questionnaire (FFQ), which was recalled over the past month and included food items, frequency, and amount of intake. The FFQ used in this study covered 72 food items from 11 food groups and 4 frequency categories, including 'average daily, weekly, monthly intake or hardly eat'. | At weeks 1, 12 and 24 |
| Physical activity level | Physical Activity Questionnaire for Children (PAQ-C) was answered by subjects. The PAQ-C reflects the overall physical activity level of children in the past 7 days.The scale consists of 10 items, .and a 1-5 scale was used to obtain a total score by summing the scores of the individual items. The PAQ-C scale scores < 2.33 defined as low physical activity levels, 2.33-3.66 as moderate physical activity levels, and >3.66 as high physical activity levels. | At weeks 1, 12 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height was measured using Height Measuring Ruler (Selcom, Germany) . | At weeks 1, 12 and 24 |
| Body weight | Body weight was measured using Body Composition Analyzer (DC-13, Parade, Japan). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University | Shenyang | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 12, 2018 | Aug 28, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 12, 2018 | Aug 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009765 | Obesity |
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| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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|
| At weeks 1, 12 and 24 |
| BMI | BMI (kg/m2) = body weight (kg)/height2 (m2). | At weeks 1, 12 and 24 |
| Waist circumference | Waist circumference was measured with circumference measuring tape. | At weeks 1, 12 and 24 |
| Waist-to-height ratio | Waist-to-height ratio (WHtR) = waist circumference (cm)/height (cm). | At weeks 1, 12 and 24 |
| Blood pressure | Blood pressure was measured using an Omron electronic blood pressure monitor (HBP-1300). | At weeks 1, 12 and 24 |
| D050177 |
| Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |