NCT01714284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2012

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

October 23, 2012

Last Update Submit

February 21, 2013

Conditions

Psoriasis

Keywords

psoriasis

Outcome Measures

Primary Outcomes (1)

  • Any change from baseline of PASI index

    20 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Diet and Exercise

EXPERIMENTAL
Behavioral: Diet and Exercise

Informative

SHAM COMPARATOR
Behavioral: Informative

Interventions

InformativeBEHAVIORAL

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

Also known as: informative, weight loss
Informative
Diet and ExerciseBEHAVIORAL

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.

Also known as: diet, weight loss, exercise
Diet and Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic plaque psoriasis
  • BMI \> 25 Kg/m²
  • Patients under systemic treatments for psoriasis or candidates for such treatments

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Department of Dermatology; Bellaria-Maggiore Hospital

Bologna, Emilia-Romagna, 40133, Italy

Location

Department of Dermatology; S.Orsola-Malpighi General Hospital

Bologna, Emilia-Romagna, 40138, Italy

Location

Dermatology Department; M. Bufalini Hospital

Cesena, Emilia-Romagna, 47521, Italy

Location

Department of Dermatology; S. Anna University Hospital

Ferrara, Emilia-Romagna, 44124, Italy

Location

Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital

Forlì, Emilia-Romagna, 47121, Italy

Location

Department of Dermatology; University General Hospital of Modena

Modena, Emilia-Romagna, 41124, Italy

Location

Department of Dermatology; University General Hospital of Parma

Parma, Emilia-Romagna, 43126, Italy

Location

Department of Dermatology; Hospital of Piacenza

Piacenza, Emilia-Romagna, 29121, Italy

Location

Department of Dermatology; AUSL of Ravenna

Ravenna, Emilia-Romagna, 48121, Italy

Location

Department of Dermatology; S. Maria Nuova Hospital

Reggio Emilia, Emilia-Romagna, 42123, Italy

Location

Department of Dermatology; Infermi Hospital

Rimini, Emilia-Romagna, 47900, Italy

Location

MeSH Terms

Conditions

Psoriasis

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Luigi Naldi, MD

    Centro Studi Gised

    STUDY DIRECTOR

  • Alberto Giannetti, MD

    University General Hospital of Modena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 25, 2012

Study Start

February 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

IT(11)