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Completed

NCT Number: NCT01714284

Efficacy Study 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.

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology; Bellaria-Maggiore Hospital, Bologna, Emilia-Romagna, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informative

Behavioral

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

Diet and Exercise

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.

Other names: diet, weight loss, exercise

Primary outcomes

  1. Any change from baseline of PASI index

    Time frame: 20 weeks

Secondary outcomes

  1. Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)

    Time frame: 8 weeks, 16 weeks, 20 weeks

  2. Percent change from baseline of PASI index equal to 100% (PASI100)

    Time frame: 8 weeks, 16 weeks, 20 weeks

  3. Any change from baseline of PASI index

    Time frame: 8 weeks, 16 weeks, 20 weeks

  4. Any reduction from baseline of Body Mass Index (BMI)

    Time frame: 8 weeks, 16 weeks, 20 weeks

  5. Any reduction from baseline of waist circumference

    Time frame: 8 weeks, 16 weeks, 20 weeks

  6. Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)

    Time frame: 8 weeks, 16 weeks, 20 weeks

Sponsors and collaborators

Lead sponsor

Centro Studi Gised

Other

Collaborators

  • Azienda Ospedaliero-Universitaria di Modena

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 25, 2012
Registry last updated
Feb 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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