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| Name | Class |
|---|---|
| Azienda Ospedaliero-Universitaria di Modena | OTHER |
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This is a multicenter randomized controlled clinical trial evaluating the impact of a structured non pharmacological intervention consisting in intensive weight reduction (qualitative and quantitative changes in diet associated with physical exercise) compared to an intervention based on a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet and Exercise | Experimental |
| |
| Informative | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Informative | Behavioral | The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Any change from baseline of PASI index | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline of PASI index equal to or greater than 50% (PASI50+) | 8 weeks, 16 weeks, 20 weeks | |
| Percent change from baseline of PASI index equal to 100% (PASI100) | 8 weeks, 16 weeks, 20 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luigi Naldi, MD | Centro Studi Gised | Study Director |
| Alberto Giannetti, MD | University General Hospital of Modena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology; Bellaria-Maggiore Hospital | Bologna | Emilia-Romagna | 40133 | Italy | ||
| Department of Dermatology; S.Orsola-Malpighi General Hospital |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
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|
| Diet and Exercise | Behavioral | The intervention consists in a 20 weeks quantitative and qualitative dietary plan for weight loss associated with physical exercise. The plan will be developed with the help of qualified staff (Dieticians) and elaborated in relation to individual needs of the patient. |
|
|
| Any change from baseline of PASI index | 8 weeks, 16 weeks, 20 weeks |
| Any reduction from baseline of Body Mass Index (BMI) | 8 weeks, 16 weeks, 20 weeks |
| Any reduction from baseline of waist circumference | 8 weeks, 16 weeks, 20 weeks |
| Percent change from baseline of PASI index equal to or greater than 75% (PASI75+) | 8 weeks, 16 weeks, 20 weeks |
| Bologna |
| Emilia-Romagna |
| 40138 |
| Italy |
| Dermatology Department; M. Bufalini Hospital | Cesena | Emilia-Romagna | 47521 | Italy |
| Department of Dermatology; S. Anna University Hospital | Ferrara | Emilia-Romagna | 44124 | Italy |
| Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital | Forlì | Emilia-Romagna | 47121 | Italy |
| Department of Dermatology; University General Hospital of Modena | Modena | Emilia-Romagna | 41124 | Italy |
| Department of Dermatology; University General Hospital of Parma | Parma | Emilia-Romagna | 43126 | Italy |
| Department of Dermatology; Hospital of Piacenza | Piacenza | Emilia-Romagna | 29121 | Italy |
| Department of Dermatology; AUSL of Ravenna | Ravenna | Emilia-Romagna | 48121 | Italy |
| Department of Dermatology; S. Maria Nuova Hospital | Reggio Emilia | Emilia-Romagna | 42123 | Italy |
| Department of Dermatology; Infermi Hospital | Rimini | Emilia-Romagna | 47900 | Italy |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |