Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000966897
Ethics application status
Approved
Date submitted
15/06/2021
Date registered
23/07/2021
Date last updated
29/06/2022
Date data sharing statement initially provided
23/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a Rugby League Community program on Women's Health
Scientific title
A pilot study testing the feasibility and acceptability of a gender-tailored weight loss and health promotion program for middle-aged women in South-Western Sydney
Secondary ID [1] 304058 0
Nil.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 321961 0
Physical Inactivity 321962 0
Insufficient dietary intake 321963 0
Depression 321964 0
Anxiety 322970 0
Condition category
Condition code
Public Health 319684 319684 0 0
Health promotion/education
Diet and Nutrition 319685 319685 0 0
Obesity
Mental Health 319686 319686 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is designed to test the feasibility and acceptability of a 12-week gender-tailored weight loss and health promotion program for middle-aged women, delivered through a professional rugby league club.

Participants will attend 12 face-to-face group sessions, scheduled on a weekly basis, at Belmore Sports Ground (Canterbury-Bankstown Bulldog's home ground). Each weekly session will run for 90 minutes and will comprise both an education and physical activity component (approximately 45 minutes in duration each). A maximum number of 30 participants may attend a group session to ensure we are adhering to Exercise and Sports Science Australia (ESSA) ratios.

Topics covered in the education sessions will include: physical activity, nutrition, and mental health. One topic will be covered in each educational session, and these topics will be scheduled prior. The content delivery will vary in each session, and activities will include brief, interactive presentations and demonstrations (e.g., cooking class) and group discussion activities.

The weekly physical activity sessions will involve supervised, low -moderate intensity (intensity based on Borg RPE) exercise (such as brisk walking and body weight exercises e.g., squats, push-ups, and crunches), and participants will be encouraged to participate at their own pace.

In addition, the education sessions will be facilitated by content area experts (i.e., PhD qualified persons with expertise in nutrition, women's health, and mental health); in the same way the physical activity sessions will be run by qualified exercise professionals (i.e., an exercise physiologist and personal trainer) who possess the skills necessary to deliver a safe program to all participants.

In between intervention sessions, participants will be encouraged to complete additional exercises (e.g., 30 mins brisk walking), however this will not be prescribed and will not be compulsory.

Each participant involved will receive a training pack, including a training shirt and drink bottle, together with free access to the 12-week program. All participants will be provided with program resources including a handbook (specifically developed for the program), generic information about health and health services (readily available e.g., Physical activity and exercise guidelines, and the Australian dietary guidelines), and an equipment pack (including a training shirt and drink bottle).

Adherence to this intervention will be monitored by session (weekly) attendance records.
Intervention code [1] 320587 0
Lifestyle
Intervention code [2] 320588 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327641 0
Feasibility [Composite outcome] - measured through the recruitment (assessed through analysis of study enrolment data) session attendance (assessed through analysis of weekly attendance records), and retention (assessed through analysis of datas from those that completed the study).
Timepoint [1] 327641 0
Cumulative data will be assessed at the conclusion of the study
Primary outcome [2] 327642 0
Acceptability (measured through a post-intervention process evaluation survey and/or focus groups). The post intervention process evaluation survey has been specifically designed for this study. All participants who complete the program will be invited to complete the process evaluation survey and/or focus group. Informed consent will be sought from all participants completing the process-evaluation focus groups and names will be collected at the beginning of the survey. In doing this we will be able to determine if a participant completes the survey and/or attends a focus group.
Timepoint [2] 327642 0
End of intervention (week 12)
Primary outcome [3] 327643 0
Weight (measured using calibrated electronic scales)
Timepoint [3] 327643 0
Baseline and week 12 (end of intervention)
Secondary outcome [1] 395699 0
Body Mass Index (BMI). This will be assessed by collecting height data determined by a stadiometer, and weight data determined using calibrated electronic scales, then using the formula BMI = kg/m2.
Timepoint [1] 395699 0
Baseline and week 12 (end of intervention)
Secondary outcome [2] 396050 0
Waist Circumference (measured using a non-elastic tape measure at the midpoint between the lowest rib and the Iliac crest)
Timepoint [2] 396050 0
Baseline and week 12 (end of intervention)
Secondary outcome [3] 396052 0
Light Physical Activity (total minutes and percentage of time to be measured using Actigraph GT3x accelerometers). For the purposes of this study light physical activity will be defined using the Troiano et al. (2008) cut points which indicate light physical activity is 100–2019 counts per minute.
Timepoint [3] 396052 0
Baseline and week 12 (end of intervention)
Secondary outcome [4] 396053 0
Dietary Intake (measured using the Healthy Eating Quiz)
Timepoint [4] 396053 0
Baseline and week 12 (end of intervention)
Secondary outcome [5] 396054 0
Blood pressure (measured using a digital upper-arm blood pressure monitor. Three measurements will be taken and averaged for an accurate reading).
Timepoint [5] 396054 0
Baseline and week 12 (end of intervention)
Secondary outcome [6] 396804 0
Moderate-to-vigorous physical activity (MVPA) - total minutes and percentage of time, measured using ActiGraph GT3X accelerometers. For the purposes of this study moderate-to-vigorous physical activity will be defined using the Troiano et al. (2008) cut points which indicate MVPA is > 2020 counts per minute.
Timepoint [6] 396804 0
Baseline and week 12 (end of intervention)
Secondary outcome [7] 396805 0
Daily step counts - to be measured using ActiGraph GT3x accelerometer.
Timepoint [7] 396805 0
Baseline and week 12 (end of intervention)

Eligibility
Key inclusion criteria
Women will be able to participate if they:
- Are aged between 35 and 64 years
- Have a BMI of 25kg/m2 or higher
- Can attend group-based sessions at Belmore Sports Ground once per week for a 12 -week period
- Pass a pre-exercise screening assessment or obtain GP clearance for participation in light to moderate intensity physical activity.
Minimum age
35 Years
Maximum age
64 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will not be eligible to participate if they:
- Have recently participated in or are intending to participate in another weight loss and health promotion program concurrently.

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
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be used for feasibility and acceptability outcomes. Non-parametric tests will be used to examine differences in weight and health-related outcomes from baseline to post-intervention.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/07/2022
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 308441 0
University
Name [1] 308441 0
Western Sydney University
Country [1] 308441 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Locked Bag 1797, Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 309505 0
None
Name [1] 309505 0
Address [1] 309505 0
Country [1] 309505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308398 0
Western Sydney University Human Research Ethics Committee
Ethics committee address [1] 308398 0
Ethics committee country [1] 308398 0
Australia
Date submitted for ethics approval [1] 308398 0
29/04/2021
Approval date [1] 308398 0
24/08/2021
Ethics approval number [1] 308398 0
H14420

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

Contacts
Principal investigator
Name 110582 0
Miss Sarah Cavallin
Address 110582 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 110582 0
Australia
Phone 110582 0
+61 0421777847
Fax 110582 0
Email 110582 0
[email protected]
Contact person for public queries
Name 110583 0
Emma George
Address 110583 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 110583 0
Australia
Phone 110583 0
+61 247360052
Fax 110583 0
Email 110583 0
[email protected]
Contact person for scientific queries
Name 110584 0
Emma George
Address 110584 0
Western Sydney University
School of Science and Health
Locked Bag 1797
Penrith NSW 2751
Country 110584 0
Australia
Phone 110584 0
+61 247360052
Fax 110584 0
Email 110584 0
[email protected]

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 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.