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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00350311




Registration number
NCT00350311
Ethics application status
Date submitted
6/07/2006
Date registered
10/07/2006
Date last updated
26/09/2008

Titles & IDs
Public title
Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study
Scientific title
Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study
Secondary ID [1] 0 0
95/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychotic Disorder 0 0
Obesity 0 0
Behavior, Addictive 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Psychosis and personality disorders
Mental Health 0 0 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - nicotine transdermal patch/lozenge

Treatment: Drugs: nicotine transdermal patch/lozenge
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Smoking Cessation
Timepoint [1] 0 0
Primary outcome [2] 0 0
Body Mass Index
Timepoint [2] 0 0

Eligibility
Key inclusion criteria
- 18-40 yrs

- DSM-IV diagnosis of non-organic psychotic illness

- Obesity (BMI > 30 or 27 if co-morbidities such as diabetes, hypertension or
dyslipidaemia are present

- Current smoker ( > 15 cigarettes per day) if also smoking cannabis regularly, they
will still be able to participate
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Medical contraindication to exercise or use of the nicotine patch

- Intellectual disability that would significantly impair ability to participate in the
program

- Inability to give informed consent (acutely psychotic potential participants will be
reassessed one month post screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2008
Sample size
Target
Accrual to date
Final
43
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Centre for Mental Health Studies, Univeristy Of Newcastle - Newcastle
Recruitment hospital [2] 0 0
School of Public Health and Community Medicine, University of New South Wales - Sydney
Recruitment hospital [3] 0 0
Department of Psychiatry, Monash University, The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Mental Health Research Institute, University of Melbourne, Royal Melbourne Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2308 - Newcastle
Recruitment postcode(s) [2] 0 0
2052 - Sydney
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The University of New South Wales
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Government Department of Health and Ageing
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study is a feasibility study of a multi-component intervention to enhance healthy living
among young people with psychotic disorders, specifically targeting smoking and weight.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00350311
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Baker, Assoc Prof
Address 0 0
Centre for Mental Health Studies, Uni of Newcastle
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00350311