Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000762156
Ethics application status
Approved
Date submitted
2/05/2019
Date registered
22/05/2019
Date last updated
1/11/2019
Date data sharing statement initially provided
22/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
South Asian Mothers Being Active (SAMBA)
Scientific title
South Asian Mothers Being Active (SAMBA): A pilot randomised controlled trial of an educational intervention developed through community participatory research, aiming to improve physical activity participation among South Asian women
Secondary ID [1] 296661 0
Healthway Project Number 31974
Universal Trial Number (UTN)
U1111-1224-2781
Trial acronym
SAMBA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical inactivity 310498 0
Condition category
Condition code
Public Health 309207 309207 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
South Asian Mother's Becoming Active (SAMBA) is a culturally-sensitive and collaboratively-designed intervention to support South Asian women to become more physically active. The intervention was developed through community-based participatory research, which included focus group discussions and individual interviews with women from the South Asian community. The aim of the intervention is to implement and evaluate a pilot, single-blinded randomized controlled trial with an experimental group of 30 South Asian women, and a delayed matched-control group, at two community settings in metropolitan Perth. Women from the Indian, Pakistani, Bangladeshi, Sri Lankan, Nepali and Bhutanese communities will be recruited to take part. We will assess changes in levels of objectively-measured physical activity, sedentary behaviour, and BMI; and psychological well being. Participants can self-select the level of intensity in which they engage with the physical activities included in the trial (i.e., there is not a 'target' level of intensity to be achieved).
Participants will attend one 90-minute session every week for 10 weeks. The sessions will be held at local community centers. Each session will include a ‘classroom style’ educational component (approximately 45 minutes), and a physical activity component (approximately 45 minutes).
The physical activity component of the intervention will include various forms of dance, aerobics, yoga and movement. The activities will be designed to suit the fitness levels of the women. Participants will be able to self-select physical activity tasks based on their perceived fitness levels (i.e., there will be no fitness tests for this pragmatic community trial). Physical activity sessions will be led by two female, community facilitators who are appropriately trained to lead such activities. Weekly physical activity sessions will be planned collaboratively by the Curtin University research staff and the community facilitators.
Prior to delivering the program, the community facilitators will receive training in motivationally-supportive communication style. The training will involve two face-to-face training sessions, each of 2-hours duration. The training will be facilitated by Curtin University research staff, with expertise in training tutors to deliver health programs in community settings. Principles from contemporary theories of motivation, such as Self-Determination Theory, will be utilised in the training. For example, the community facilitators will be trained to use strategies such as acknowledging feelings, offering choice and appropriate explanations, involving the participants in the decision-making process, and promoting feelings of competence in behaviour change that are based on personal progression rather than comparison with others. The community facilitators will then be provided opportunities to practice session delivery and receive feedback. The community facilitators will also have access to supporting resources relating to motivationally-supportive communication style. These resources have been developed by the research team for application in this and other motivationally-supportive physical activity programs.
The educational component of the intervention will be delivered by Curtin University research staff, with qualifications in Public Health, Psychology, and Education. The content will be delivered face-to-face, and additional supporting resources will be supplied to participants, including hard copy and electronic resources. The aims of the educational sessions will be to introduce some key, empirically-derived, behaviour-change techniques. Specifically, topics will include:
• The health benefits of performing regular physical activity and minimising prolonged sedentary behaviour.
• The Australian Government recommendations in relation to physical activity and sedentary behaviour for adults.
• How to plan physical activity to suit your lifestyle.
• Practical tips for incorporating physical activity into everyday life (e.g., taking the stairs rather than the lift when possible).
• Overcoming barriers, problem solving, and coping with challenges that might disrupt or inhibit physical activity.
• The role of motivation and how to develop more self-determined motivation to be physically active.
• Strategies for setting achievable goals and the importance of revising those goals over time.
• The benefits of self-monitoring physical activity performance (e.g. keeping a physical activity diary).
• Strategies to develop self-efficacy for physical activity (e.g. behavioural practice/rehearsal or graded tasks).
• Developing social support for physical activity (e.g., restructuring the social environment).
A multi-component process evaluation (including self-administered questionnaires focus group discussions with women, interviews the physical activity community facilitators, and coded audio recordings of the facilitators’ communication style at three randomly selected program delivery sessions) will be undertaken in accordance with the Medical Research Council guidelines and other relevant evaluation frameworks.
Weekly attendance records will be kept. Participants who drop out of the program will be asked to take part in structured telephone interviews which will examine their reasons for disengagement.
The community facilitators will then train a group of eight volunteer women (i.e., external volunteers from community organizations) in continuing to deliver a PA program to communities. This training program will be developed based on the findings of the process evaluation, with the frequency and duration of training sessions to be determined in accordance with those findings. The intervention training package (training of the facilitators and the weekly intervention content) will be made freely available so that it can be potentially replicated with other culturally and linguistically diverse communities. The initial training program will be delivered face-to-face, with the sessions video recorded so they can be utilised in other settings in the future.
Intervention code [1] 312968 0
Behaviour
Intervention code [2] 312969 0
Prevention
Intervention code [3] 313980 0
Lifestyle
Comparator / control treatment
The delayed matched control group will receive the intervention 12 weeks after baseline
Control group
Active

Outcomes
Primary outcome [1] 319484 0
Mother’s total light, moderate, and vigorous physical activity assessed using ActivGraph GT9X Link accelerometers.
Timepoint [1] 319484 0
The intervention group will be measured at timepoint one (baseline measure, week 0), timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).
Secondary outcome [1] 368376 0
Minutes spent sitting per day assessed using ActivGraph GT9X Link accelerometers.
Timepoint [1] 368376 0
The intervention group will be measured at timepoint one (baseline measure, week 0), timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).
Secondary outcome [2] 368377 0
Body Mass Index (weight(kgs)/height2. Weight (kgs) will be assessed via a TANITA weighing scale, height will be measured via a SECA stadiometer.
Timepoint [2] 368377 0
The intervention group will be measured at timepoint one (baseline measure, week 0), timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).
Secondary outcome [3] 368378 0
Self-report moderate and vigorous physical activity assessed with the International Physical Activity Questionnaire - short form (IPAQ Research Committee)
Timepoint [3] 368378 0
The intervention group will be measured at recruitment stage, timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).
Secondary outcome [4] 368379 0
Motivation for physical activity will be assessed with the Behavioural Regulation for Exercise Questionnaire - 3 (Marland & Tobin, 2004; Wilson, Rodgers, Loitz, & Scime, 2006).
Timepoint [4] 368379 0
The intervention group will be measured at timepoint one (baseline measure, week 0), timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).
Secondary outcome [5] 368381 0
Psychological needs support for exercise (competence, autonomy, and relatedness). The women's perceptions of psychological needs support will be assessed on the Basic Psychological Needs in Exercise Scale (Vlachopoulos & Michailidou, 2006).
Timepoint [5] 368381 0
The intervention group will be measured at timepoint two (post-intervention measure, week 11).
The delayed matched control group will be measured at timepoint three (post intervention measure - week 22).
Secondary outcome [6] 368382 0
Quality of life and psychological wellbeing will be assessed on the SF-12 Health Survey (Ware Jr, Kosinski, & Keller, 1996).
Timepoint [6] 368382 0
The intervention group will be measured at timepoint one (baseline measure, week 0), timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).
Secondary outcome [7] 368383 0
Self-esteem will be assessed on the Harter self-esteem questionnaire physical appearance and global self-worth sub-scales (Messer & Harter, 1986).
Timepoint [7] 368383 0
The intervention group will be measured at timepoint one (baseline measure, week 0), timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).
Secondary outcome [8] 368386 0
Effects of the motivational training of the facilitators - 26 item participant questionnaire (Ntoumanis, Thogersen-Ntoumani, Quested, & Hancox, 2017)
Timepoint [8] 368386 0
The intervention group will be measured at timepoint two (post-intervention measure, week 11).
The delayed matched control group will be measured at timepoint three (post intervention measure - week 22).
Secondary outcome [9] 368388 0
Trial evaluation. Participant satisfaction with SAMBA will be assessed by participant questionnaire including items developed specifically for the study, in addition to focus group interviews with mother and child participants (focus groups will be conducted until data saturation is determined; however, at least 2 focus groups of 30-60 minutes duration will be conducted, with a minimum of 3 mothers and 3 children in each group).
Timepoint [9] 368388 0
The intervention group will be measured at timepoint two (post-intervention measure, week 11).
The delayed matched control group will be measured at timepoint three (post intervention measure - week 22).
Secondary outcome [10] 369904 0
Questionnaire items developed for this study will assess demographic characteristics including country of birth, country of origin, date of arrival in Australia, languages spoken, marital status, number of children, education, and employment status.
Timepoint [10] 369904 0
All participants will be measured at Baseline (week 0)
Secondary outcome [11] 370472 0
Waist circumference in centimeters - taken using a tape measure.
Timepoint [11] 370472 0
The intervention group will be measured at timepoint one (baseline measure, week 0), timepoint two (post-intervention measure, week 11), timepoint three (follow-up measure, week 22).
The delayed matched control group will be measured at timepoint one (baseline measure, week 0), timepoint two (for comparison with intervention group post-intervention measure, week 11), timepoint three (post intervention measure - week 22), timepoint four (follow-up measure - week 33).

Eligibility
Key inclusion criteria
South Asian women who are able to communicate well in English, provide consent, participate in baseline assessments, have no terminal illnesses or health problems that prevent them from doing physical activity, who do not currently meet the physical activity recommendations for health (i.e. <150 minutes of moderate intensity physical activity per week) will be eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Woman performs more than 150 minutes or more of moderate-to-vigorous physical activity per week, health problems precluding physical activity, does not communicate well in English.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be completed by a researcher not involved in assessments and the allocation sequence will be concealed (central randomisation by computer) when enrolling participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random order generation - done with a computer-based random number-producing algorithm
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of intent-to-treat Linear Mixed Models in Mplus will be developed in order to test differences between the two groups across time in the primary outcome and all secondary outcomes. Linear mixed models are less sensitive to participant attrition than ANOVA and multiple imputation, and will be used to reduce the impact of missing data. Sub-group analyses will also be carried out to test differences in intervention effectiveness as a function of baseline levels in the observed variables. Trial feasibility will be reported using descriptive statistics and percentages.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/05/2019
Actual
4/06/2019
Date of last participant enrolment
Anticipated
31/05/2020
Actual
Date of last data collection
Anticipated
7/02/2021
Actual
Sample size
Target
80
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 301240 0
Government body
Name [1] 301240 0
Western Australian Health Promotion Foundation (Healthway)
Country [1] 301240 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St
Bentley
Perth
WA 6102
Country
Australia
Secondary sponsor category [1] 300872 0
None
Name [1] 300872 0
Address [1] 300872 0
Country [1] 300872 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301979 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301979 0
Office of Research and Development
GPO Box U1987
Perth
Western Australia
6845
Ethics committee country [1] 301979 0
Australia
Date submitted for ethics approval [1] 301979 0
Approval date [1] 301979 0
13/02/2019
Ethics approval number [1] 301979 0
HRE2018-0351

Summary
Brief summary
South Asian Mother's Becoming Active (SAMBA) is a culturally-sensitive and collaboratively-designed intervention to support South Asian women to become more physically active. The intervention was developed through community-based participatory research, that included focus group discussions and individual interviews with women from the South Asian community. The aim of the intervention is to implement and evaluate a pilot, single-blinded randomized controlled trial with an experimental group of 40 South Asian women, and a delayed matched-control group, at two community settings in metropolitan Perth. Women from the Indian, Pakistani, Bangladeshi, Sri Lankan, Nepali and Bhutanese communities will be recruited to take part. We will assess changes in levels of objectively-measured physical activity, sedentary behaviour, and BMI; in addition to self-reported physical activity-related motivation, and psychological well being.
Trial website
http://samba-project.com.au/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88750 0
Prof Jaya Dantas
Address 88750 0
School of Public Health
Curtin University
Kent St
Bentley
WA 6845
Country 88750 0
Australia
Phone 88750 0
+61 8 9266 4151
Fax 88750 0
Email 88750 0
jaya.dantas@curtin.edu.au
Contact person for public queries
Name 88751 0
Prof Jaya Dantas
Address 88751 0
School of Public Health
Curtin University
Kent St
Bentley
WA 6845
Country 88751 0
Australia
Phone 88751 0
+61 8 9266 4151
Fax 88751 0
Email 88751 0
jaya.dantas@curtin.edu.au
Contact person for scientific queries
Name 88752 0
Prof Nikos Ntoumanis
Address 88752 0
School of Psychology
Curtin University
Kent St
Bentley
WA 6845
Country 88752 0
Australia
Phone 88752 0
+61 8 9266 3297
Fax 88752 0
Email 88752 0
Nikos.Ntoumanis@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication of the results of the trial, no end date.
Available to whom?
Access to the data will be assessed on a case-by-case basis at the discretion of Chief Investigators of the project.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Data will be accessible on the Open Science Framework (https://osf.io/) subject to approvals by project Chief Investigators


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1981Informed consent form    376423-(Uploaded-02-05-2019-15-23-38)-Study-related document.pdf
1982Ethical approval    376423-(Uploaded-02-05-2019-15-24-11)-Study-related document.pdf



Results publications and other study-related documents

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