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Clinical Trials/NCT01714284
NCT01714284CompletedNot Applicable

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

Centro Studi Gised11 sites in 1 country303 target enrollmentStarted: February 1, 2011Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
303
Locations
11
Primary Endpoint
Any change from baseline of PASI index
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Diet and Exercise

Experimental

Intervention: Diet and Exercise (Behavioral)

Informative

Sham Comparator

Intervention: Informative (Behavioral)

Outcomes

Primary Outcomes

Any change from baseline of PASI index

Time Frame: 20 weeks

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (11)

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