PsoriasisNCT01714284
Efficacy Study of Dietary Intervention and Weight Loss in Improving Psoriasis
A study testing Informative and Diet and Exercise in people with Psoriasis, run by Centro Studi Gised at 11 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Informative and Diet and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 11 sitesItaly
- Study dates
- Feb 2011to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic plaque psoriasis
- BMI > 25 Kg/m²
- Patients under systemic treatments for psoriasis or candidates for such treatments
Who cannot join
- 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 locations and contacts
11 sites in 1 country.
11 sites in 1 country
Italy11 sites
Department of Dermatology; Bellaria-Maggiore Hospital
Bologna, Emilia-Romagna, 40133
Department of Dermatology; S.Orsola-Malpighi General Hospital
Bologna, Emilia-Romagna, 40138
Dermatology Department; M. Bufalini Hospital
Cesena, Emilia-Romagna, 47521
Department of Dermatology; S. Anna University Hospital
Ferrara, Emilia-Romagna, 44124
Department of Dermatology; G.B.Morgagni-L.Pierantoni Hospital
Forlì, Emilia-Romagna, 47121
Department of Dermatology; University General Hospital of Modena
Modena, Emilia-Romagna, 41124
Department of Dermatology; University General Hospital of Parma
Parma, Emilia-Romagna, 43126
Department of Dermatology; Hospital of Piacenza
Piacenza, Emilia-Romagna, 29121
Department of Dermatology; AUSL of Ravenna
Ravenna, Emilia-Romagna, 48121
Department of Dermatology; S. Maria Nuova Hospital
Reggio Emilia, Emilia-Romagna, 42123
Department of Dermatology; Infermi Hospital
Rimini, Emilia-Romagna, 47900
About this study
Official title: Multicenter Randomized Clinical Study Evaluating the Efficacy 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.
- Conditions
- Psoriasis
- Being tested
- Informative, Diet and Exercise
- Keywords
- psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformativeBehavioural
Also called informative, weight loss
The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
Diet and ExerciseBehavioural
Also called diet, weight loss, 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.
| Study group | Role | What they receive |
|---|---|---|
| Diet and Exercise | Experimental | Not described Receives: Behavioral: Diet and Exercise |
| Informative | Sham comparator | Not described Receives: Behavioral: Informative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any change from baseline of PASI index
Measured: 20 weeks
Secondary outcomes (6)
Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)
Measured: 8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to 100% (PASI100)
Measured: 8 weeks, 16 weeks, 20 weeks
Any change from baseline of PASI index
Measured: 8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of Body Mass Index (BMI)
Measured: 8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of waist circumference
Measured: 8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)
Measured: 8 weeks, 16 weeks, 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro Studi Gised
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Modena
- Responsible party
- Sponsor
- Investigators
- Luigi Naldi, MD, Study director, Centro Studi GisedAlberto Giannetti, MD, Principal investigator, University General Hospital of Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01714284
- Sponsor's protocol ID
- PSODIET1
- Status last verified
- Feb 2013
- First submitted
- 23 Oct 2012
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Clinical Study Evaluating the Efficacy of Dietary Intervention and Weight Loss in Improving Psoriasis
- ClinicalTrials.gov ID
- NCT01714284
- Acronym / sponsor ID
- PSODIET1
- Conditions
- Psoriasis
- Keywords
- psoriasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Centro Studi GisedUniversity, hospital or other
- Collaborators
- Azienda Ospedaliero-Universitaria di Modena
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet and Exercise | Experimental | Behavioral: Diet and Exercise |
| Informative | Sham comparator | Behavioral: Informative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic plaque psoriasis
- BMI > 25 Kg/m²
- Patients under systemic treatments for psoriasis or candidates for such treatments
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InformativeAlso: informative, weight lossThe intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease. | Behavioural | Informative |
| Diet and ExerciseAlso: diet, weight loss, exerciseThe 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. | Behavioural | Diet and Exercise |
Primary outcome
Any change from baseline of PASI index
Time frame: 20 weeks
6 secondary outcomes
Percent change from baseline of PASI index equal to or greater than 50% (PASI50+)
Time frame: 8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to 100% (PASI100)
Time frame: 8 weeks, 16 weeks, 20 weeks
Any change from baseline of PASI index
Time frame: 8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of Body Mass Index (BMI)
Time frame: 8 weeks, 16 weeks, 20 weeks
Any reduction from baseline of waist circumference
Time frame: 8 weeks, 16 weeks, 20 weeks
Percent change from baseline of PASI index equal to or greater than 75% (PASI75+)
Time frame: 8 weeks, 16 weeks, 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Naldi, MD study director
Centro Studi Gised
Alberto Giannetti, MD principal investigator
University General Hospital of Modena
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informative and Diet and Exercise in people with Psoriasis, run by Centro Studi Gised at 11 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any change from baseline of PASI index (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2013.