Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000572369
Ethics application status
Approved
Date submitted
21/08/2008
Date registered
12/11/2008
Date last updated
6/11/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Challenging barriers to undertaking physical activity amongst Community and Linguistically diverse (CALD) groups
Scientific title
Exploring the use of health professional facilitated sessions aiming to challenge perceived barriers to participating in physical activity amongst Macedonian and Polish older people (55+) in the western metropolitan region of Melbourne.
Secondary ID [1] 283517 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity level 3591 0
Physical fitness 3592 0
Readiness to change physical activity level 3593 0
Condition category
Condition code
Public Health 3752 3752 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three one hour sessions of health professional facilitated education interventions. The second session was held after 2 weeks and third session four weeks after that. Sessions involved discussion of barriers to physical activity and individual goal setting to increase physical activity levels. Participants were provided with handout which they used to document their physical activity goals and plans
Intervention code [1] 3306 0
Behaviour
Intervention code [2] 3307 0
Lifestyle
Comparator / control treatment
One hour presentation that discussed general health promotion including topics of nutrition, falls prevention, General practitioner (GP) check ups etc. This did not include discussion about physical activity.
Control group
Active

Outcomes
Primary outcome [1] 4649 0
Pedometer reading (steps per day)
Timepoint [1] 4649 0
Baseline and 1 to 2 weeks post intervention
Primary outcome [2] 4650 0
Stages of Change questionnaire category, measuring participants' preparedness to undertake physical activity as a health promoting behaviour.
Timepoint [2] 4650 0
Baseline and 1 to 2 weeks post intervention
Primary outcome [3] 4651 0
Human Activity Profile adjusted activity score (AAS), measuring participants' physical activity level in commonly daily activities.
Timepoint [3] 4651 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [1] 7858 0
Distance (metres) walked in six minutes
Timepoint [1] 7858 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [2] 7859 0
Gait speed (m/sec) from six metre walk test
Timepoint [2] 7859 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [3] 7860 0
Stride length from six metre walk test
Timepoint [3] 7860 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [4] 7861 0
Global leg strength; measured by time in seconds to stand up and sit down five times
Timepoint [4] 7861 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [5] 7862 0
Self reported health (Two SF-36 questions)
Timepoint [5] 7862 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [6] 7863 0
Self reported weekly physical activity
Timepoint [6] 7863 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [7] 7864 0
Self reported falls and injuries in preceeding three months.
Timepoint [7] 7864 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [8] 7865 0
Self reported medication usage (number and type of medications taken)
Timepoint [8] 7865 0
Baseline and 1 to 2 weeks post intervention
Secondary outcome [9] 7866 0
Body mass index
Timepoint [9] 7866 0
Baseline and 1 to 2 weeks post intervention

Eligibility
Key inclusion criteria
Attendance at a participating Polish or Macedonian social group.
Able to understand and participate in verbal discussion in english, polish or macedonian.
Albe to walk independently (with or without gait aid) for at least five minutes indoors.
Aged 55 years or over.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Unable to fulfil inclusion criteria

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Researchers attended social group twice and described the project to all group members. Interested subjects received information and consented to the study on one of the two days.
Participants were randomally assigned to experimental group by researcher randomly drawing an opaque envelope in participants' order of assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randonimsation was undertaken to control for the social group attended. CALD group was controlled for by running control and intervention groups at each facility.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2008
Actual
12/02/2008
Date of last participant enrolment
Anticipated
Actual
15/04/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1112 0
3020
Recruitment postcode(s) [2] 1113 0
3021
Recruitment postcode(s) [3] 1114 0
3025
Recruitment postcode(s) [4] 1115 0
3029

Funding & Sponsors
Funding source category [1] 3766 0
Other Collaborative groups
Name [1] 3766 0
HealthWest partnership
Country [1] 3766 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
National Ageing Research Institute
Address
PO Box 2127
Royal Melbourne Hospital
3050, Victoria
Country
Australia
Secondary sponsor category [1] 3378 0
Other Collaborative groups
Name [1] 3378 0
HealthWest partnership
Address [1] 3378 0
PO Box 5102
Sunshine 3020
Country [1] 3378 0
Australia
Other collaborator category [1] 378 0
Charities/Societies/Foundations
Name [1] 378 0
Australian Polish Community Services
Address [1] 378 0
77 Droop Street
Footscray 3011
Victoria
Country [1] 378 0
Australia
Other collaborator category [2] 379 0
Charities/Societies/Foundations
Name [2] 379 0
Macedonian Community Welfare Association
Address [2] 379 0
Po Box 436
St Albans 3021
Victoria
Country [2] 379 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5826 0
Melbourne Health Human Research and Ethics Committee
Ethics committee address [1] 5826 0
Ethics committee country [1] 5826 0
Australia
Date submitted for ethics approval [1] 5826 0
07/08/2007
Approval date [1] 5826 0
15/08/2007
Ethics approval number [1] 5826 0
HREC Project 2007.160

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

Contacts
Principal investigator
Name 28868 0
Prof Keith Hill
Address 28868 0
National Ageing Research Institute Public and Preventive Health Division PO Box 2127 Royal Melbourne Hospital Parkville 3050 Victoria
Country 28868 0
Australia
Phone 28868 0
+61 3 83872200
Fax 28868 0
Email 28868 0
[email protected]
Contact person for public queries
Name 12025 0
Ms Kirsten Moore
Address 12025 0
National Ageing Research Institute
Public and Preventive Health Division
PO Box 2127
Royal Melbourne Hospital
Parkville 3050
Victoria
Country 12025 0
Australia
Phone 12025 0
+61 3 83872200
Fax 12025 0
+61 3 83872153
Email 12025 0
[email protected]
Contact person for scientific queries
Name 2953 0
Ms Kirsten Moore
Address 2953 0
National Ageing Research Institute
Public and Preventive Health Division
PO Box 2127
Royal Melbourne Hospital
Parkville 3050
Victoria
Country 2953 0
Australia
Phone 2953 0
+61 3 83872200
Fax 2953 0
+61 3 83872153
Email 2953 0
[email protected]

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.