Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Behavioral: Informative
* Behavioral: Diet and Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic plaque psoriasis BMI > 25 Kg/m² Patients under systemic treatments for psoriasis or candidates for such treatments Exclusion Criteria: Diagnosis of other type of psoriasis or psoriatic arthritis Patients under local treatments or candidates for such treatments Patients expected to have poor compliance at follow-up evaluation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet and Exercise<br> | Behavioral: Diet and Exercise<br>* 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.<br>* Other names: diet, weight loss, exercise;|
| Sham Comparator: Informative<br> | Behavioral: Informative<br>* The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.<br>* Other names: informative, weight loss;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any change from baseline of PASI index |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis