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Post-marketing observational study of a nutritional care plan, including a higher calorie, higher protein oral nutritional supplement (ONS), prescribed to Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished. The objective is to assess the impact of the ONS on body weight, activities of daily living and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement | Free living and residing and nursing home malnourished patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | BMI will be calculated: weight (kg)/ height (cm)^2 | Change from baseline to 12 weeks |
| Katz Activities of Daily Living | A standardized, validated tool that asks about independence in bathing, dressing, toileting, transferring, continence and feeding. |
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Inclusion Criteria:
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Spanish patients, both free living and residing and nursing homes, who have been identified as malnourished.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kristen DeLuca, MS, RD | Contact | 614-624-5455 | kristen.deluca@abbott.com |
| Name | Affiliation | Role |
|---|---|---|
| Rebeca Sanz Barriuso, RD, PharmD | Abbott Nutrition | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario | Recruiting | Valladolid | 47005 | Spain |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Change from baseline to 12 weeks |
| Quality of Life | EQ5D, self-reported quality of life tool | Change from baseline to 12 weeks |