Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

February 21, 2013 updated by: Centro Studi Gised

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Emilia Romagna
      • Bologna, Emilia Romagna, Italy, 40133
        • Department of Dermatology; Bellaria-Maggiore Hospital
      • Bologna, Emilia Romagna, Italy, 40138
        • Department of Dermatology; S.Orsola-Malpighi General Hospital
      • Cesena, Emilia Romagna, Italy, 47521
        • Dermatology Department; M. Bufalini Hospital
      • Ferrara, Emilia Romagna, Italy, 44124
        • Department of Dermatology; S. Anna University Hospital
      • Forlì, Emilia Romagna, Italy, 47121
        • Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital
      • Modena, Emilia Romagna, Italy, 41124
        • Department of Dermatology; University General Hospital of Modena
      • Parma, Emilia Romagna, Italy, 43126
        • Department of Dermatology; University General Hospital of Parma
      • Piacenza, Emilia Romagna, Italy, 29121
        • Department of Dermatology; Hospital of Piacenza
      • Ravenna, Emilia Romagna, Italy, 48121
        • Department of Dermatology; AUSL of Ravenna
      • Reggio Emilia, Emilia Romagna, Italy, 42123
        • Department of Dermatology; S. Maria Nuova Hospital
      • Rimini, Emilia Romagna, Italy, 47900
        • Department of Dermatology; Infermi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diet and Exercise
Behavioral: Diet and Exercise
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.
Other Names:
  • diet, weight loss, exercise
Sham Comparator: Informative
Behavioral: Informative
The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
Other Names:
  • informative, weight loss

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Any change from baseline of PASI index
Time Frame: 20 weeks
20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)
Time Frame: 8 weeks, 16 weeks, 20 weeks
8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to 100% (PASI100)
Time Frame: 8 weeks, 16 weeks, 20 weeks
8 weeks, 16 weeks, 20 weeks
Any change from baseline of PASI index
Time Frame: 8 weeks, 16 weeks, 20 weeks
8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of Body Mass Index (BMI)
Time Frame: 8 weeks, 16 weeks, 20 weeks
8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of waist circumference
Time Frame: 8 weeks, 16 weeks, 20 weeks
8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)
Time Frame: 8 weeks, 16 weeks, 20 weeks
8 weeks, 16 weeks, 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Studi Gised

Collaborators

Azienda Ospedaliero-Universitaria di Modena

Investigators

  • Study Director: Luigi Naldi, MD, Centro Studi Gised
  • Principal Investigator: Alberto Giannetti, MD, University General Hospital of Modena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 23, 2012

First Posted (Estimate)

October 25, 2012

Study Record Updates

Last Update Posted (Estimate)

February 22, 2013

Last Update Submitted That Met QC Criteria

February 21, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSODIET1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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