Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000023550
Ethics application status
Approved
Date submitted
13/01/2006
Date registered
16/01/2006
Date last updated
10/06/2021
Date data sharing statement initially provided
10/06/2021
Date results information initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Steps: A trial of pedometer-based Green Prescription for older adults
Scientific title
Healthy Steps: A trial of pedometer-based Green Prescription to improve physical activity, health-related quality of life, and health and physical functioning in low-active older adults
Universal Trial Number (UTN)
Trial acronym
Healthy Steps
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 984 0
Condition category
Condition code
Public Health 1059 1059 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Intervention - New Zealand Green Prescription modified to incorporate pedometers: A combination of primary care physican counseling and telephone counseling over three months using motivational interviewing and cognitive behavioural techniques incorporating step-based physical activity goals (using pedometers).
Intervention code [1] 838 0
Prevention
Comparator / control treatment
Control Intervention - New Zealand Green Prescription: A combination of primary care physican counseling and telephone counseling over three months using motivational interviewing and cognitive behavioural techniques incorporating time-based physical activity goals.
Control group
Active

Outcomes
Primary outcome [1] 1416 0
(1) physical activity (as measured by the Auckland Heart Study Physical Activity Questionnaire)
Timepoint [1] 1416 0
All outcomes will be assessed at baseline, at 3 months (end of intervention), and at 12 months (as follow-up).
Primary outcome [2] 1417 0
(2) health-related quality of life (as measured by the SF-36)
Timepoint [2] 1417 0
All outcomes will be assessed at baseline, at 3 months (end of intervention), and at 12 months (as follow-up).
Primary outcome [3] 1418 0
(3) blood pressure
Timepoint [3] 1418 0
All outcomes will be assessed at baseline, at 3 months (end of intervention), and at 12 months (as follow-up).
Primary outcome [4] 1419 0
(4) functional capacity and disability risk as measured by gait speed, chair stands, and the tandem balance test as part of the Established Population for Epidemiologic Studies of the Elderly battery
Timepoint [4] 1419 0
All outcomes will be assessed at baseline, at 3 months (end of intervention), and at 12 months (as follow-up).
Primary outcome [5] 1420 0
(5) Quality Adjusted Life Years (as measured by the EQ-5D)
Timepoint [5] 1420 0
All outcomes will be assessed at baseline, at 3 months (end of intervention), and at 12 months (as follow-up).
Primary outcome [6] 1421 0
(6) amount of walking in the previous day
Timepoint [6] 1421 0
All outcomes will be assessed at baseline, at 3 months (end of intervention), and at 12 months (as follow-up).
Secondary outcome [1] 2504 0
Falls and injuries will be assessed via calendars completed prospectively by participants
Timepoint [1] 2504 0
In months 1, 2, 3, 6, 9, and 12. These calendars will be collected from participants at the end of each of these months.

Eligibility
Key inclusion criteria
(1) Low active (i.e., have not engaged in at least 150 minutes of moderate physical activity accumulated over at least 5 days in a week). (2) Plan to live in Auckland, New Zealand for at least 12 months from the time of their recruitment to the trial. (3) An ability to comprehend English to the level required for the physician and telephone counseling.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) A medical history or major health problem that meant walking would be contraindicated (as assessed by their primary care physician and the Physical Activity Readiness Questionnaire). (2) Visual problems to the level of not being able to read the step counts on a pedometer.

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)
Computer generated random numbers will be used. The researcher performing the randomisation will be unaware of whom each ID number is related to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers will be used. Patients from each medical clinic will be randomised in blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2006
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
3/12/2007
Date of last data collection
Anticipated
Actual
31/12/2008
Sample size
Target
350
Accrual to date
Final
330
Recruitment outside Australia
Country [1] 258 0
New Zealand
State/province [1] 258 0

Funding & Sponsors
Funding source category [1] 1160 0
Government body
Name [1] 1160 0
Health Research Council of New Zealand
Country [1] 1160 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1020
Country
New Zealand
Secondary sponsor category [1] 1021 0
University
Name [1] 1021 0
University of Auckland
Address [1] 1021 0
Private Bag 92019, Auckland 1020
Country [1] 1021 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308733 0
New Zealand Ministry of Health Health and Disability Ethics Committee
Ethics committee address [1] 308733 0
Nil
Ethics committee country [1] 308733 0
New Zealand
Date submitted for ethics approval [1] 308733 0
30/11/2005
Approval date [1] 308733 0
07/12/2005
Ethics approval number [1] 308733 0

Summary
Brief summary
The Health Steps study is a trial to establish the efficacy of a pedometer-based Green Prescription (a step-based physical activity script to engage and maintain low-active older adults in regular health-related physical activity) compared with the conventional time-based Green Prescription. As well, the cost-effectiveness of the pedometer-based Green Prescription will be compared with that of the conventional Green Prescription to understand the potential cost and benefit of such an innovation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36114 0
Prof Gregory Kolt
Address 36114 0
Western Sydney University
Country 36114 0
Australia
Phone 36114 0
+61 2 4620 3747
Fax 36114 0
Email 36114 0
[email protected]
Contact person for public queries
Name 10027 0
Prof Professor Gregory Kolt
Address 10027 0
Western Sydney University, School of Health Sciences, Locked Bag 1797, Penrith NSW 2751
Country 10027 0
Australia
Phone 10027 0
+61 2 4620 3747
Fax 10027 0
+61 2 4620 3710
Email 10027 0
[email protected]
Contact person for scientific queries
Name 955 0
Prof Professor Gregory Kolt
Address 955 0
Western Sydney University, School of Health Sciences, Locked Bag 1797, Penrith NSW 2751
Country 955 0
Australia
Phone 955 0
+61 2 4620 3747
Fax 955 0
+61 2 4620 3710
Email 955 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Kolt, G. S., Schofield, G. M., Kerse, N., Garrett,... [More Details]

Documents added automatically
No additional documents have been identified.