Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000158460
Ethics application status
Approved
Date submitted
8/02/2016
Date registered
10/02/2016
Date last updated
10/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Making active choices more attractive: Do physical activity incentives improve heart health?
Scientific title
Making active choices more attractive: Effectiveness of incentivising physical activity and reduced sitting time to improve heart health
Secondary ID [1] 288497 0
Heart Foundation Vanguard Grant, Award number 100572
Universal Trial Number (UTN)
U111-1179-3384
Trial acronym
ACHIEVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 297560 0
Sedentary behaviour 297561 0
Condition category
Condition code
Public Health 297761 297761 0 0
Health promotion/education
Cardiovascular 297773 297773 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves providing relatively small, intermittent incentives in the form of points exchangeable for gift vouchers, offered over a 4-month period, to participants who successfully increase their physical activity or decrease their sitting time. Participants will be awarded one point per minute (capped at 30 points/day) of physical activity, and one point per minute (capped at 30 points/day) reduction of sitting time. Weight reduction is NOT a points incentive in this study but rather will be monitored as an outcome. Incentives are supplemented with a one-on-one motivational interview with a member of the research staff, for around 20 minutes duration, focused on goal-setting and addressing barriers at intervention commencement; and weekly SMS text messages providing encouragement/support. Participants also receive a Fitbit One device and Bluetooth weighing scales.
Intervention code [1] 293861 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297292 0
Physical activity duration assessed by International Physical Activity Questionnaire
Timepoint [1] 297292 0
Immediately post-intervention (4 months post-baseline)
Secondary outcome [1] 320632 0
Sedentary time assessed by International Physical Activity Questionnaire
Timepoint [1] 320632 0
Measured at baseline and immediately post-intervention (4 months post-baseline)
Secondary outcome [2] 320639 0
BMI, based on height and weight - measured by researchers at baseline; measured by participants on Bluetooth scales provided and self-reported at mid-intervention and post-intervention (4-month post-baseline)
Timepoint [2] 320639 0
Measured at baseline, mid-intervention (2-months post-baseline) and immediately post-intervention (4 months post-baseline)
Secondary outcome [3] 320640 0
Blood pressure (systolic and diastolic) measured by participants using a Omron Wrist Blood Pressure monitor (Model #: HEM-6121)
Timepoint [3] 320640 0
Measured at baseline and immediately post-intervention (4 months post-baseline)

Eligibility
Key inclusion criteria
Members of GMHBA health insurance
Aged 40-65 years
Physically inactive (exercise less than 30 mins/day; usually spend more than three-quarters of the day sitting)
Have access to a mobile phone and internet
Live within 25km of study site (Burwood, Victoria)
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil apart from not meeting the inclusion criteria

Study design
Purpose of the study
Prevention
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
Based on our previous physical activity studies, a sample of 80 adults was calculated to provide 80% power at a=0.05 to detect an effect size in the primary outcome, physical activity duration, of at least 0.3 (equivalent to 60 minutes of physical activity/week, an increase that is feasible but significant in this initially sedentary sample), allowing for up to 10% attrition over the 4-month study period. Study effects will be evaluated using t-tests and regression models predicting change in key outcomes from pre- to post-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/05/2015
Date of last participant enrolment
Anticipated
Actual
27/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292852 0
Charities/Societies/Foundations
Name [1] 292852 0
National Heart Foundation of Australia
Country [1] 292852 0
Australia
Primary sponsor type
Individual
Name
Kylie Ball
Address
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 291596 0
Individual
Name [1] 291596 0
David Crawford
Address [1] 291596 0
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country [1] 291596 0
Australia
Other collaborator category [1] 278812 0
Individual
Name [1] 278812 0
Jo Salmon
Address [1] 278812 0
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country [1] 278812 0
Australia
Other collaborator category [2] 278813 0
Individual
Name [2] 278813 0
Marj Moodie
Address [2] 278813 0
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country [2] 278813 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294353 0
Human Ethics Advisory Group, Faculty of Health, Deakin University
Ethics committee address [1] 294353 0
221 Burwood Hwy
Burwood VIC 3125
Ethics committee country [1] 294353 0
Australia
Date submitted for ethics approval [1] 294353 0
07/10/2014
Approval date [1] 294353 0
21/10/2014
Ethics approval number [1] 294353 0
HEAG-H 179_2014

Summary
Brief summary
This project aims to test the feasibility and effectiveness of incentives for promoting increased physical activity, decreased sedentary behaviour, and improvements in heart health risk factors among adults. We hypothesised that an intervention involving relatively small, intermittent incentives in the form of points exchangeable for gift vouchers, offered over a 4-month period, and supplemented by an initial motivational interview and regular motivational text (mobile-phone SMS) messages, will lead to significant increases in time spent in physical activity; decreases in time spent in sedentary behaviours; and decreases in BMI and blood pressure, among middle-aged (40-65 year old) adults. Participants receive one point per minute, capped at 30 minutes per day, for engaging in physical activity; and one point per minute, also capped at 30 minutes per day, for reducing their sedentary time. Physical activity and sedentary time are monitored using a Fitbit One device provided to participants and linked to a purpose-designed study website that records points.
Trial website
Trial related presentations / publications
Ball, K., Ong, KL., Hunter, R., Salmon, J., Jackson, M., Moodie, M., Chisholm, M., Skoko, M., Crawford, D. The Active Choices Incentive (ACHIEVE) study. Australian and New Zealand Obesity Society Annual Scientific Meeting, Melbourne, Australia, October 2015.
Public notes

Contacts
Principal investigator
Name 63386 0
Prof Kylie Ball
Address 63386 0
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 63386 0
Australia
Phone 63386 0
+61392517310
Fax 63386 0
+61392446017
Email 63386 0
[email protected]
Contact person for public queries
Name 63387 0
Kylie Ball
Address 63387 0
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 63387 0
Australia
Phone 63387 0
+61392517310
Fax 63387 0
+61392446017
Email 63387 0
[email protected]
Contact person for scientific queries
Name 63388 0
Kylie Ball
Address 63388 0
Deakin University
221 Burwood Hwy
Burwood VIC 3125
Country 63388 0
Australia
Phone 63388 0
+61392517310
Fax 63388 0
+61392446017
Email 63388 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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