Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000012572
Ethics application status
Approved
Date submitted
10/12/2014
Date registered
9/01/2015
Date last updated
14/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Trial of the effect of incentives and support to increase leisure centre usage by inactive people in Frankston
Scientific title
Randomised controlled trial of the impact of incentives and support to increase organised physical activity among inactive residents of Frankston
Secondary ID [1] 285825 0
Nil
Universal Trial Number (UTN)
U1111-1165-0798
Trial acronym
MOVE Frankston
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity

 293740 0
Mental health 293793 0
Condition category
Condition code
Public Health 294040 294040 0 0
Health promotion/education
Mental Health 294041 294041 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two levels of intervention being tested over a two-year period:
Intervention 1: participants can redeem a free pass within the first six months of the study for a single visit to the Peninsula Aquatic and Recreation Centre allowing pool usage, gym usage, an exercise class or spa/warm water pool use.
Intervention 2: This comprises intervention 1, plus: generic congratulatory SMS/letter for those redeeming passes, or 15 min follow-up and encouragement phone call from a health educator for those not redeeming passes; 2 x 15 min phone contacts per year (4 over two years) from a health educator to discuss usage of Centre and give support in developing plans for physical activity; 4 x two-page newsletters per year with practical advice and encouragement concerning physical activity, and; posted Christmas and Birthday cards each year with brief physical activity messages included.

All study members are given a PARC digital swipe card, which has a unique identification number embedded in it, that can be used to record their use of the facility on a monthly basis.
Intervention code [1] 290803 0
Behaviour
Intervention code [2] 290804 0
Lifestyle
Comparator / control treatment
Control group members receive no treatment.
Control group
Active

Outcomes
Primary outcome [1] 293817 0
Physical activity participation measured by the Exercise Recreation and Sport Survey developed by the Australian sports Commission, and monthly recording of PARC visits based on swipe card data
Timepoint [1] 293817 0
12 month and 24 months after recruitment
Primary outcome [2] 293818 0
Mental well being measured by the Warwick Edinburgh Mental Well-Being scale, and single item measure of global mental health
Timepoint [2] 293818 0
12 months and 24 months after recruitment
Secondary outcome [1] 311927 0
Self efficacy measured by an adapted single item measure of self-reported self-efficacy for physical activity
Timepoint [1] 311927 0
12 months and 24 months after recruitment
Secondary outcome [2] 311928 0
Attitudes measured by a validated single item measure of personal rewards gained from physical activity
Timepoint [2] 311928 0
12 months and 24 months after recruitment

Eligibility
Key inclusion criteria
Reside in Frankston City Council area; do not meet the Australian national physical activity guidelines; do not attend gym or leisure centre on a weekly basis
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to converse in English; physical illness or disability that prevents walking for 10 minutes or more; cognitive problem that impairs communication or reasoning

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)
Recruitment and allocation were done by separate researchers. Allocation took place centrally several weeks after recruitment and baseline measurement by means of computer generated random numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomised number sequence created by computer software
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
Sample size was determined as the number needed to show a significant difference in weekly participation in organised physical activity. It is assumed that 10% of control subjects will become regular participants in organised physical activity. Therefore a sample size of 300 in each arm of the study will be required to show with 95% confidence limits and 80% power: (i) a 10% difference in outcome between participants in Intervention 1 and the control group (i.e., 20% vs. 10%); and (ii) a 10% difference between those in Intervention 1 and Intervention 2 (i.e., 30% vs. 20%). To accommodate a 25% drop out among recruited participants over the two year course of the study, the target sample size was inflated to 400 per group.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
24/07/2014
Date of last participant enrolment
Anticipated
Actual
17/09/2014
Date of last data collection
Anticipated
20/12/2016
Actual
Sample size
Target
1200
Accrual to date
Final
1380
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9041 0
3195 - Aspendale
Recruitment postcode(s) [2] 9042 0
3196 - Chelsea
Recruitment postcode(s) [3] 9043 0
3197 - Carrum
Recruitment postcode(s) [4] 9044 0
3198 - Seaford
Recruitment postcode(s) [5] 9045 0
3199 - Frankston
Recruitment postcode(s) [6] 9046 0
3200 - Frankston North
Recruitment postcode(s) [7] 9047 0
3201 - Carrum Downs
Recruitment postcode(s) [8] 9048 0
3911 - Langwarrin South
Recruitment postcode(s) [9] 9049 0
3910 - Langwarrin
Recruitment postcode(s) [10] 9050 0
3977 - Cranbourne

Funding & Sponsors
Funding source category [1] 290387 0
Government body
Name [1] 290387 0
Australian Research Council
Country [1] 290387 0
Australia
Funding source category [2] 290388 0
Government body
Name [2] 290388 0
Frankston City Council
Country [2] 290388 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Research Office
Monash University
Building 3d
Monash University
Victoria 3800
Country
Australia
Secondary sponsor category [1] 289114 0
None
Name [1] 289114 0
Address [1] 289114 0
Country [1] 289114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292091 0
Monash University Human Reseach Ethics Committee
Ethics committee address [1] 292091 0
Ethics committee country [1] 292091 0
Australia
Date submitted for ethics approval [1] 292091 0
Approval date [1] 292091 0
26/05/2014
Ethics approval number [1] 292091 0
CF14/1148 - 2014000497

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

Contacts
Principal investigator
Name 53438 0
A/Prof Ben Smith
Address 53438 0
School of Public Health and Preventive Medicine
Monash University
Level 6
99 Commercial Rd
Melbourne, Victoria, 3004
Country 53438 0
Australia
Phone 53438 0
+61 3 99031654
Fax 53438 0
Email 53438 0
[email protected]
Contact person for public queries
Name 53439 0
Ben Smith
Address 53439 0
School of Public Health and Preventive Medicine
Monash University
Level 6
99 Commercial Rd
Melbourne, Victoria, 3004
Country 53439 0
Australia
Phone 53439 0
+61 3 99031654
Fax 53439 0
Email 53439 0
[email protected]
Contact person for scientific queries
Name 53440 0
Ben Smith
Address 53440 0
School of Public Health and Preventive Medicine
Monash University
Level 6
99 Commercial Rd
Melbourne, Victoria, 3004
Country 53440 0
Australia
Phone 53440 0
+61 3 99031654
Fax 53440 0
Email 53440 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
SourceTitleYear of PublicationDOI
EmbaseThe MOVE study: a study protocol for a randomised controlled trial assessing interventions to maximise attendance at physical activity facilities.2015https://dx.doi.org/10.1186/s12889-015-1735-0
EmbaseEffects of customer relationship management (CRM) strategies and socio-cognitive constructs on the physical activity of individuals with arthritis over time.2023https://dx.doi.org/10.1371/journal.pone.0292692
N.B. These documents automatically identified may not have been verified by the study sponsor.