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| Name | Class |
|---|---|
| Taras Shevchenko National University of Kyiv | OTHER |
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The main medical and social purpose of the project "It's trendy to be healthy!" is the promotion of healthy lifestyles and healthy eating among student youth. The relevance of this project is beyond doubt, as the WHO called obesity a non-communicable epidemic, and according to research by the Jane Schiller University of Germany (Germany), as mentioned above, Ukraine topped the list of the countries with high mortality due to malnutrition
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care group | Active Comparator | 3-month course of individually selected nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily) |
|
| intervention group | Experimental | additionally to previous group recieved treatment with synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103) and vitamin D3 - 2000 IU. The students were instructed to take vitamin D3 and synbiotic sachets twice a day for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nutrition program and modification of physical activity | Other | nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Rathus Assertiveness Schedule | RAS is consists of 30 questions and is divided into five subgroups, according to the scores: 0-24: very insecure; 25-48: rather unsure than confident; 49-72: average confidence value; 73-96: self-confident and 97-120: overconfident. | 90 days compared to baseline |
| Changes in test "Diagnosis of situational and personal anxiety" | Test " Diagnosis of situational and personal anxiety" by Ch. D. Spielberger consists of 20 statements that refer to anxiety as a state (state of anxiety, reactive (RA) or situational anxiety (SA)) and 20 statements to define anxiety as a disposition, personality traits (anxiety property). | 90 days compared to baseline |
| Measure | Description | Time Frame |
|---|---|---|
| weight | weight in kg | at 45 and 90 days compared to baseline |
| waist circumferences (WC) | WC in cm | at 45 and 90 days compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nataliia Molochek, PhD | ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv | Study Director |
| Liudmyla Ostapchenko, Professor | ESC "Institute of Biology and Medicine", Taras Shevchenko National University of Kyiv | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bogomolets National Medical University | Kyiv | 01601 | Ukraine | |||
| Taras Shevchenko National University of Kyiv |
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| synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU) | Dietary Supplement | one synbiotic sachet (3g), BID, for 3 month traetment |
|
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| vitamin D3 | Dietary Supplement | vitamin D3, oral, 2000IU BID, for 3 month treatment |
|
|
| body mass index (BMI) | weight in kg and height in meters will be combined to report BMI in kg/m^2 | at 45 and 90 days compared to baseline |
| muscle mass | muscle mass (kg) using electronic scales-analyzers of body composition Tanita Scale BC-601 | at 45 and 90 days compared to baseline |
| fat content | fat content (%) using electronic scales-analyzers of body composition Tanita Scale BC-601 | at 45 and 90 days compared to baseline |
| systolic blood pressure (SBP) | Blood pressure is measured from the right hand while sitting with the help of a mercury barometer "OMRON". Blood pressure is taken twice at a 5-minute interval while seated for 5 minutes. | at 45 and 90 days compared to baseline |
| diastolic blood pressure (DBP) | Blood pressure is measured from the right hand while sitting with the help of a mercury barometer "OMRON". Blood pressure is taken twice at a 5-minute interval while seated for 5 minutes. | at 45 and 90 days compared to baseline |
| HbA1c | HbA1c in % | 90 days compared to baseline |
| fasting plasma glucose (FPG) | FPG in mmol/L | 90 days compared to baseline |
| total cholesterol (TC) | TC in mmol/L | 90 days compared to baseline |
| Total vitamin D3 | Total vitamin D3, ng/ml | 90 days compared to baseline |
| Kyiv |
| 01601 |
| Ukraine |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D014808 | Vitamin D Deficiency |
| D003863 | Depression |
| ID | Term |
|---|---|
| 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 |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D058616 | Synbiotics |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D056692 | Prebiotics |
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019936 | Probiotics |
| D019602 | Food and Beverages |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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