Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

303 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet and Exercise

Group Type EXPERIMENTAL

Diet and Exercise

Intervention Type BEHAVIORAL

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.

Informative

Group Type SHAM_COMPARATOR

Informative

Intervention Type BEHAVIORAL

The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.

Interventions

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Informative

The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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informative, weight loss diet, weight loss, exercise

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No