Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis

Centro Studi Gised

Status: Completed

Conditions: Psoriasis

Treatments: Behavioral: Diet and Exercise; Behavioral: Informative

Study type: Interventional

Funder types: Other

Identifiers

NCT01714284

PSODIET1

Details and patient eligibility

About

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.

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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303 participants in 2 patient groups

Diet and Exercise

Experimental group

Treatment:

Behavioral: Diet and Exercise

Informative

Sham Comparator group

Treatment:

Behavioral: Informative