Back to resultsEfficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis
Primary Purpose
Psoriasis
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Informative
Diet and Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis focused on measuring psoriasis
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
Sites / Locations
- Department of Dermatology; Bellaria-Maggiore Hospital
- Department of Dermatology; S.Orsola-Malpighi General Hospital
- Dermatology Department; M. Bufalini Hospital
- Department of Dermatology; S. Anna University Hospital
- Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital
- Department of Dermatology; University General Hospital of Modena
- Department of Dermatology; University General Hospital of Parma
- Department of Dermatology; Hospital of Piacenza
- Department of Dermatology; AUSL of Ravenna
- Department of Dermatology; S. Maria Nuova Hospital
- Department of Dermatology; Infermi Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Diet and Exercise
Informative
Arm Description
Outcomes
Primary Outcome Measures
Any change from baseline of PASI index
Secondary Outcome Measures
Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)
Percent change from baseline of PASI index equal to 100% (PASI100)
Any change from baseline of PASI index
Any reduction from baseline of Body Mass Index (BMI)
Any reduction from baseline of waist circumference
Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)
Full Information
NCT ID
NCT01714284
First Posted
October 23, 2012
Last Updated
February 21, 2013
Sponsor
Centro Studi Gised
Collaborators
Azienda Ospedaliero-Universitaria di Modena
1. Study Identification
Unique Protocol Identification Number
NCT01714284
Brief Title
Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis
Official Title
Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro Studi Gised
Collaborators
Azienda Ospedaliero-Universitaria di Modena
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diet and Exercise
Arm Type
Experimental
Arm Title
Informative
Arm Type
Sham Comparator
Intervention Type
Behavioral
Intervention Name(s)
Informative
Other Intervention Name(s)
informative, weight loss
Intervention Description
The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
Intervention Type
Behavioral
Intervention Name(s)
Diet and Exercise
Other Intervention Name(s)
diet, weight loss, exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Any change from baseline of PASI index
Time Frame
20 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)
Time Frame
8 weeks, 16 weeks, 20 weeks
Title
Percent change from baseline of PASI index equal to 100% (PASI100)
Time Frame
8 weeks, 16 weeks, 20 weeks
Title
Any change from baseline of PASI index
Time Frame
8 weeks, 16 weeks, 20 weeks
Title
Any reduction from baseline of Body Mass Index (BMI)
Time Frame
8 weeks, 16 weeks, 20 weeks
Title
Any reduction from baseline of waist circumference
Time Frame
8 weeks, 16 weeks, 20 weeks
Title
Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)
Time Frame
8 weeks, 16 weeks, 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luigi Naldi, MD
Organizational Affiliation
Centro Studi Gised
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alberto Giannetti, MD
Organizational Affiliation
University General Hospital of Modena
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology; Bellaria-Maggiore Hospital
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40133
Country
Italy
Facility Name
Department of Dermatology; S.Orsola-Malpighi General Hospital
City
Bologna
State/Province
Emilia Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Dermatology Department; M. Bufalini Hospital
City
Cesena
State/Province
Emilia Romagna
ZIP/Postal Code
47521
Country
Italy
Facility Name
Department of Dermatology; S. Anna University Hospital
City
Ferrara
State/Province
Emilia Romagna
ZIP/Postal Code
44124
Country
Italy
Facility Name
Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital
City
Forlì
State/Province
Emilia Romagna
ZIP/Postal Code
47121
Country
Italy
Facility Name
Department of Dermatology; University General Hospital of Modena
City
Modena
State/Province
Emilia Romagna
ZIP/Postal Code
41124
Country
Italy
Facility Name
Department of Dermatology; University General Hospital of Parma
City
Parma
State/Province
Emilia Romagna
ZIP/Postal Code
43126
Country
Italy
Facility Name
Department of Dermatology; Hospital of Piacenza
City
Piacenza
State/Province
Emilia Romagna
ZIP/Postal Code
29121
Country
Italy
Facility Name
Department of Dermatology; AUSL of Ravenna
City
Ravenna
State/Province
Emilia Romagna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Department of Dermatology; S. Maria Nuova Hospital
City
Reggio Emilia
State/Province
Emilia Romagna
ZIP/Postal Code
42123
Country
Italy
Facility Name
Department of Dermatology; Infermi Hospital
City
Rimini
State/Province
Emilia Romagna
ZIP/Postal Code
47900
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis
We'll reach out to this number within 24 hrs