Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.



Please note that the ANZCTR website will be unavailable from 1pm until 2:30pm (AEDT) on Thursday 28th November for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000291886
Ethics application status
Approved
Date submitted
8/03/2012
Date registered
13/03/2012
Date last updated
13/03/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Physical activity for adults with serious mental illness.
Scientific title
Second generation antipsychotic weight gain and the facilitators and barriers to physical activity for adults with serious mental illness: a qualitative study.
Secondary ID [1] 280094 0
Nil
Universal Trial Number (UTN)
U1111-1128-9752
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 286009 0
Schizophrenia 286010 0
Condition category
Condition code
Physical Medicine / Rehabilitation 286150 286150 0 0
Other physical medicine / rehabilitation
Mental Health 286196 286196 0 0
Schizophrenia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The barriers and enablers of physical activity for adults with serious mental illness and effects of medications on lifestyles will be elicited through qualitative interviews or focus groups. Interviews and focus groups are antipated to last for up to one hour.
Intervention code [1] 284421 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286671 0
The primary outcome in this study are participants views pertaining to barriers and enablers of physical activity, and effects of medications on lifestyles. The data on these outcomes will be assessed with thematic analysis.
Timepoint [1] 286671 0
Data analysis of the primary outcome will be conducted through April and May 2012, approximately two to three months after the completion of data collection.
Secondary outcome [1] 296422 0
Nil
Timepoint [1] 296422 0
Nil

Eligibility
Key inclusion criteria
People with a diagnosis of serious mental illness by DSMIV or ICD-10 criteria for less than or more than 12 months;
Taking second generation antipsychotics;
Able to communicate verbally in English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to comunicate

Study design
Purpose
Duration
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5087 0
5009
Recruitment postcode(s) [2] 5086 0
5113

Funding & Sponsors
Funding source category [1] 284853 0
Government body
Name [1] 284853 0
South Australian Department of Health
Country [1] 284853 0
Australia
Primary sponsor type
Individual
Name
Julie Ayliffe
Address
C/O University of South Australia
School of Nursing and Midwifery
GPO Box 2471
Adelaide, South Australia 5001
Australia
Ph +61 8 8302 6611
Fax +61 8 8302 2466
Country
Australia
Secondary sponsor category [1] 283731 0
None
Name [1] 283731 0
Address [1] 283731 0
Country [1] 283731 0
Other collaborator category [1] 260608 0
Government body
Name [1] 260608 0
Club 84 - Recovery and Rehabilitation Program
Address [1] 260608 0
84 Yorketown Road
Elizabeth Park 5113
South Australia
Country [1] 260608 0
Australia
Other collaborator category [2] 260607 0
Charities/Societies/Foundations
Name [2] 260607 0
Mind Australia - South Australian State Office
Address [2] 260607 0
210 Greenhill Road
Eastwood 5063
South Australia
Country [2] 260607 0
Australia
Other collaborator category [3] 260609 0
Charities/Societies/Foundations
Name [3] 260609 0
Diamond House SA Inc.
Address [3] 260609 0
19 Kilkenny Road
Kilkenny 5011
South Australia
Country [3] 260609 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286841 0
South Australian Department of Health Human Research Ethics Commitee
Ethics committee address [1] 286841 0
Ethics committee country [1] 286841 0
Australia
Date submitted for ethics approval [1] 286841 0
Approval date [1] 286841 0
22/12/2011
Ethics approval number [1] 286841 0
484/11/2014
Ethics committee name [2] 286842 0
University of South Australia Human Research Ethics Commitee
Ethics committee address [2] 286842 0
Ethics committee country [2] 286842 0
Australia
Date submitted for ethics approval [2] 286842 0
Approval date [2] 286842 0
23/11/2011
Ethics approval number [2] 286842 0
0000026029

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33853 0
Address 33853 0
Country 33853 0
Phone 33853 0
Fax 33853 0
Email 33853 0
Contact person for public queries
Name 17100 0
Julie Ayliffe
Address 17100 0
University of South Australia
City East Campus
Corner North Terrace & Frome St
GPO Box 2471
Adelaide, South Australia 5001
Australia
Country 17100 0
Australia
Phone 17100 0
+61 8 8302 6611
Fax 17100 0
+61 8 8302 2466
Email 17100 0
ayljy0002@mymail.unisa.edu.au
Contact person for scientific queries
Name 8028 0
Julie Ayliffe
Address 8028 0
University of South Australia
City East Campus
Corner North Terrace & Frome St
GPO Box 2471
Adelaide, South Australia 5001
Australia
Country 8028 0
Australia
Phone 8028 0
+61 8 8302 6611
Fax 8028 0
+61 8 8302 2466
Email 8028 0
ayljy0002@mymail.unisa.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.