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| Name | Class |
|---|---|
| Complejo Hospitalario de Navarra | OTHER |
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The objectives of the present study are: 1) to identify the intestinal and salivary microbiota associated with the presence and severity of hepatic steatosis in children (Study I: case-control study), and 2) to develop a personalized 12-week intervention program based on diet and exercise to examine its effects on the diversity and composition of the microbiota in children with hepatic steatosis (Study II: intervention study)
The MicroKid project will acts first as a case-control study (Study I) in order to identify the hepatic steatosis and intestinal and salivary microbiota in children grouped as non-overweight, obese-non-hepatic steatosis, and obese-hepatic steatosis. Then, an intervention study (Study II) will be developed for those children with obesity (i.e., obese-non-hepatic steatosis, and obese-hepatic steatosis groups).
Methodology: A total of 60 children, 8-12 years-old, will be assigned to control (non-overweight children, N= 20), obese-non-hepatic steatosis (children with obesity, but without hepatic steatosis, N=20), and obese-hepatic steatosis (children with obesity and hepatic steatosis, N= 20) groups (Study I: case-control study). The obesity and obesity + hepatic steatosis groups will attend to a 12-weeks healthy lifestyle education program (2 days/month) and home-based exercise program (minimum 3 days/week) (Study II: intervention study).
The combined intervention program for the Study II will include: i) healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and ii) exercise program based on high-intensity interval training which combines aerobic and resistance training (at least 3 days/week, from 38 to 44 min).
Measurements: In the Study I (i.e., case-control study), all participants will be evaluated at baseline. For the Study II (i.e., intervention study), only those participants that belongs to obese-non-hepatic steatosis and obese-hepatic steatosis groups, will be additionally evaluated after the intervention program (12-week). The following outcomes will be measured: hepatic fat fraction and abdominal adiposity (magnetic resonance imaging), intestinal and salivary microbiota, body composition (bioimpedance), cardiometabolic risk factors, liver enzymes, physical fitness (field-fitness tests), physical activity (accelerometry), sleep (accelerometry), dietary habits (24h recalls, and food frequency questionnaires), and pubertal development and sociodemographic characteristics will be measured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | ||
| Obesity-Non-hepatic steatosis | Active Comparator | Healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and exercise program based on high-intensity interval training which combine aerobic and resistance training (at least 3 days/week, from 38 to 44 min). |
|
| Obesity-Hepatic steatosis | Experimental | Healthy lifestyle education program focused on dietary and lifestyle guidelines for both children and parents (2 days/month, 60 min), and exercise program based on high-intensity interval training which combine aerobic and resistance training (at least 3 days/week, from 38 to 44 min). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary intervention program | Other | The intervention program includes an educational program promoting healthy dietary habits and physical activity (nutritionist and exercise physiologist) (2 times/month, for children and parents), and supervised home-based exercise (from 3 to 5 times/week, 38-44 min) program for 12-weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic fat | Hepatic fat fraction measured by magnetic resonance imaging before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Intestinal microbiota | Diversity and composition of intestinal microbiota before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Salivary microbiota | Diversity and composition of salivary microbiota before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Visceral adiposity | Visceral adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Subcutaneous abdominal adiposity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario de Navarra | Pamplona | Spain | ||||
| Public University of Navarra |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
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|
Subcutaneous abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program
| baseline and post-test (12-weeks) |
| Intermuscular abdominal adiposity | Intermuscular abdominal adipose tissue measured by magnetic resonance imaging before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Weight | Weight measured by bioimpedance before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Height | Height measured by stadiometer before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Fat mass | Fat mass measured by bioimpedance before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Fat-free mass | Fat free mass measured by bioimpedance before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Glucose | Glucose measured by blood analysis before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Insulin | Serum insulin concentration measured by ELISA before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Cholesterol | Serum cholesterol measured by spectrophotometry before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Triglycerides | Serum triglycerides measured by spectrophotometry before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Leptin | Plasma leptin concentration measured by ELISA before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Adiponectin | Plasma adiponectin measured by ELISA before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| C-reactive protein | Plasma hs-CRP measured by ELISA before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Waist circumference | Waist circumference measured by non-elastic tape before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Systolic and diastolic blood pressure | Systolic and diastolic blood pressure measured by sphygmomanometer before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Physical fitness | Cardiorespiratory fitness, upper- and lower-limbs, and speed agility measured by the Alpha-fitness battery. | baseline and post-test (12-weeks) |
| Physical activity and sleep | Physical activity and sleep measured by accelerometry before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| 24h dietary habits | 24h dietary habits assessed by 24h recalls before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Dietary habits history | Dietary habits history assessed by food frequency questionnaires before and after 12-weeks intervention program | baseline and post-test (12-weeks) |
| Pamplona |
| Spain |
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001519 | Behavior |