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Trial registered on ANZCTR


Registration number
ACTRN12618001392257
Ethics application status
Approved
Date submitted
3/08/2018
Date registered
20/08/2018
Date last updated
6/02/2019
Date data sharing statement initially provided
6/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot physical activity intervention for middle-aged Arab-Australian women
Scientific title
A pilot culturally-tailored intervention to increase physical activity and reduce sedentary behaviour among Arab-Australian women aged 35-64.
Secondary ID [1] 295607 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 308928 0
Condition category
Condition code
Public Health 307831 307831 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot study is a culturally-tailored physical activity (PA) intervention designed for middle-aged (35-64 years) Arab-Australian women. To ensure that this intervention is culturally-appropriate and acceptable for the target population, the cultural-tailoring process of this intervention was informed by formative research. Briefly, this included a systematic review of physical activity interventions conducted among culturally and linguistically diverse populations and also a qualitative study with the target population exploring the barriers and enablers to PA.

Participants will attend 6 face-to-face group-based sessions scheduled on a fortnightly basis over a period of 12 weeks and each session will take between 1.5-2 hours in duration. Each session will include educational and practical PA sessions. Educational sessions for the intervention will be conducted with the whole group in a collaborative learning environment and will include a combination of lectures, group discussions, and smaller group activities (e.g., groups of 5). Topics covered will include: what is PA, health benefits of PA, strategies to increase PA, goal setting, and social support for physical activity. The PA sessions will consist of activities involving the whole group (e.g., group brisk walk) and smaller group activities (e.g., body weight exercises). The activities will be of light-moderate intensity catering to all fitness and skill levels and will include culturally-relevant forms of PA. The intervention will take place at Western Sydney University campuses and community centres. Adherence to the intervention will be monitored by session (fortnightly) attendance records. The educational component of the intervention will be co-facilitated by a PhD candidate with a background in Health and Physical Education and a trained female research assistant and the physical activity component of the intervention will be facilitated by a trained female research assistant.
Intervention code [1] 301906 0
Lifestyle
Comparator / control treatment
N/A.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306808 0
Physical activity - measured using ActiGraph GT3X accelerometers and short-form IPAQ questionnaire.
Timepoint [1] 306808 0
Baseline, Week 12 (end of intervention)
Secondary outcome [1] 349706 0
Waist circumference - measured using a non-elastic tape measure at the midpoint between the lowest rib and the iliac crest
Timepoint [1] 349706 0
Baseline, Week 12 (end of intervention)
Secondary outcome [2] 349707 0
Quality of life - SF36 Survey
Timepoint [2] 349707 0
Baseline, Week 12 (end of intervention)

Eligibility
Key inclusion criteria
- Female
- Self-identify as having Arab Ancestry (Lebanese, Syrian, Palestinian, Jordanian, Egyptian, Iraqi, Kuwaiti, Saudi Arabian, Bahraini, Qatari, Yemeni, Omani, and Emirati origin)
- Living in Australia
- Aged 35-64 years
- Insufficiently active or inactive at baseline (i.e., <150 minutes of moderate-vigorous PA per week)
- No current chronic disease/illness
Minimum age
35 Years
Maximum age
64 Years
Gender
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- participants who accumulate at least 150 minutes or more of moderate-vigorous PA per week.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Generalised linear mixed models will be used to examine differences in physical activity, waist circumference, and quality of life between the intervention and control group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 300209 0
University
Name [1] 300209 0
Western Sydney University
Address [1] 300209 0
Locked Bag 1797, Penrith NSW 2751
Country [1] 300209 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 299592 0
None
Name [1] 299592 0
Address [1] 299592 0
Country [1] 299592 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301013 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 301013 0
Locked Bag 1797, Penrith NSW 2751
Ethics committee country [1] 301013 0
Australia
Date submitted for ethics approval [1] 301013 0
26/04/2018
Approval date [1] 301013 0
31/07/2018
Ethics approval number [1] 301013 0
H12725

Summary
Brief summary
To our knowledge, there are no known scientifically evaluated physical activity interventions designed for middle aged Arab-Australian women. While there are a host programs and interventions designed for the general population, these are not applicable to those from culturally and linguistically diverse (CALD) backgrounds and more specifically Arab-Australian women. Due to the unique needs and requirements of each CALD group, it is important to individually tailor and target interventions to suit a specific population of interest. This intervention will be a 12-week culturally-tailored physical activity intervention designed for Arab-Australian women aged 35-64 years.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85602 0
Mr Aymen El Masri
Address 85602 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 85602 0
Australia
Phone 85602 0
+61247360779
Fax 85602 0
Email 85602 0
a.elmasri@westernsydney.edu.au
Contact person for public queries
Name 85603 0
Dr Emma George
Address 85603 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 85603 0
Australia
Phone 85603 0
+61247360052
Fax 85603 0
Email 85603 0
e.george@westernsydney.edu.au
Contact person for scientific queries
Name 85604 0
Dr Emma George
Address 85604 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 85604 0
Australia
Phone 85604 0
+61247360052
Fax 85604 0
Email 85604 0
e.george@westernsydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable