Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Azienda Ospedaliera - Universitaria di Modena
Information provided by (Responsible Party):
Centro Studi Gised
ClinicalTrials.gov Identifier:
NCT01714284
First received: October 23, 2012
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Psoriasis
Behavioral: Informative
Behavioral: Diet and Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis

Resource links provided by NLM:


Further study details as provided by Centro Studi Gised:

Primary Outcome Measures:
  • Any change from baseline of PASI index [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change from baseline of PASI index equal to or greater than 50% (PASI50+) [ Time Frame: 8 weeks, 16 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline of PASI index equal to 100% (PASI100) [ Time Frame: 8 weeks, 16 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Any change from baseline of PASI index [ Time Frame: 8 weeks, 16 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Any reduction from baseline of Body Mass Index (BMI) [ Time Frame: 8 weeks, 16 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Any reduction from baseline of waist circumference [ Time Frame: 8 weeks, 16 weeks, 20 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline of PASI index equal to or greater than 75% (PASI75+) [ Time Frame: 8 weeks, 16 weeks, 20 weeks ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: February 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: informative, weight loss

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01714284

Locations
Italy
Department of Dermatology; S.Orsola-Malpighi General Hospital
Bologna, Emilia Romagna, Italy, 40138
Department of Dermatology; Bellaria-Maggiore Hospital
Bologna, Emilia Romagna, Italy, 40133
Dermatology Department; M. Bufalini Hospital
Cesena, Emilia Romagna, Italy, 47521
Department of Dermatology; S. Anna University Hospital
Ferrara, Emilia Romagna, Italy, 44124
Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital
Forlì, Emilia Romagna, Italy, 47121
Department of Dermatology; University General Hospital of Modena
Modena, Emilia Romagna, Italy, 41124
Department of Dermatology; University General Hospital of Parma
Parma, Emilia Romagna, Italy, 43126
Department of Dermatology; Hospital of Piacenza
Piacenza, Emilia Romagna, Italy, 29121
Department of Dermatology; AUSL of Ravenna
Ravenna, Emilia Romagna, Italy, 48121
Department of Dermatology; S. Maria Nuova Hospital
Reggio Emilia, Emilia Romagna, Italy, 42123
Department of Dermatology; Infermi Hospital
Rimini, Emilia Romagna, Italy, 47900
Sponsors and Collaborators
Centro Studi Gised
Azienda Ospedaliera - Universitaria di Modena
Investigators
Study Director: Luigi Naldi, MD Centro Studi Gised
Principal Investigator: Alberto Giannetti, MD University General Hospital of Modena
  More Information

No publications provided

Responsible Party: Centro Studi Gised
ClinicalTrials.gov Identifier: NCT01714284     History of Changes
Other Study ID Numbers: PSODIET1
Study First Received: October 23, 2012
Last Updated: February 21, 2013
Health Authority: Italy: Ethics Committee
Italy: National Bioethics Committee

Keywords provided by Centro Studi Gised:
psoriasis

Additional relevant MeSH terms:
Psoriasis
Weight Loss
Skin Diseases, Papulosquamous
Skin Diseases
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014