Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000558426
Ethics application status
Approved
Date submitted
12/10/2007
Date registered
31/10/2007
Date last updated
17/12/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Home-based Physical Activity Program for Seniors
Scientific title
Motivational interviewing to promote physical activity in older adults
Secondary ID [1] 283788 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MOVES - Motivating Older adults to Value Exercise Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adherence 2452 0
Body weight and composition 2453 0
Blood pressure 2454 0
Fitness 2455 0
Mental Health 2456 0
Condition category
Condition code
Cardiovascular 2553 2553 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will evaluate the effects of two educational approaches, usual care and behavioural intervention and two motivational techniques, standard instruction and motivational interviewing. The intervention will be for an initial 6 months with a follow-up after a further 6 months during which participants will be asked to continue with their exercise but will not receive any further intervention. All participants will be asked to complete 150 minutes of moderate physical activity per week (3 X 50 minutes). All participants will attend a 2-hour workshop. One hour will outline the program, the safety aspects of exercise and participants will take part in a demonstration session. The other hour will be used to cover the specific intervention for each group.
The behavioural intervention is based on the Stages of Change Model and consists of information and worksheets including topics such as goal setting, time management and overcoming barriers to exercise. The behavioural intervention will be included in a participant manual and will be briefly outlined (10-15 minutes) in part of the main workshop.
The motivational interviewing will be delivered in a 45-minute workshop and will include worksheets included in the manual. It will be followed up with 4 phone calls one every 6 weeks over the initial 6 months, they will be of 10-15 minute duration and start at week 3.
Intervention code [1] 2180 0
Lifestyle
Comparator / control treatment
Usual care educational package and standard telephone follow-up.
The usual care education group will receive instruction (60 minutes) on what type of exercise they can do, when to do it and what resources are available in the community. They will receive a manual with community activities and a copy of booklets from 2 community groups, one on walking the other on activities for seniors.
The standard telephone instruction will consist of 4 phone calls one every 6 weeks over the initial 6 months, they will be of 10-15 minute duration and start at week 3.
The participants will be asked about progress on their exercise and comments will be recorded. There will be no specific ‘motivational talk’ and the content of the calls will be minimally discussed except in the case of where safety issues are raised.
Control group
Active

Outcomes
Primary outcome [1] 3460 0
Adherence
Timepoint [1] 3460 0
Baseline, 6 and 12 months
Secondary outcome [1] 5774 0
Blood Pressure
Timepoint [1] 5774 0
Baseline, 6 and 12 months
Secondary outcome [2] 5775 0
Body weight and body composition
Timepoint [2] 5775 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
Age 50-80 years, non smoking, healthy, but sedentary men and women.
Minimum age
50 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
smokers, physically active, cardiovascular disease, diabetes, untreated hypertension, Body Mass Index (BMI)>34, musculo-skeletal condition preventing moderate physical activity

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)
Participants will be telephoned screened and if meeting the criteria will attend 2 screening visits. There will be a 4-6 week baseline and familiarisation period. Participants will be stratified and matched on gender and BMI and randomly assigned to the 4 treatment groups by a statistician using computer generated random numbers concealed from the study personnel. Allocation will be concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated random numbers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/10/2007
Actual
15/10/2007
Date of last participant enrolment
Anticipated
1/09/2008
Actual
19/03/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2700 0
Government body
Name [1] 2700 0
Healthway WA
Country [1] 2700 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Medicine and Pharmacology
GPO Box X2213 Perth
WA 6847
Country
Australia
Secondary sponsor category [1] 2444 0
University
Name [1] 2444 0
Edith Cowan University
Address [1] 2444 0
100 Joondalup Drive
Joondalup WA.6027
Country [1] 2444 0
Australia
Other collaborator category [1] 70 0
University
Name [1] 70 0
Edith Cowan University
Address [1] 70 0
100 Joondalup Drive
Joondalup WA.6027
Country [1] 70 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4620 0
University of Western Australia Human Research Ethics Committee
Ethics committee address [1] 4620 0
35 Stirling Hwy
Crawley WA 6009
Ethics committee country [1] 4620 0
Australia
Date submitted for ethics approval [1] 4620 0
Approval date [1] 4620 0
08/01/2007
Ethics approval number [1] 4620 0
RA/4/1/1679

Summary
Brief summary
Aim:
The aim of this study is to assess the short and long-term efficacy of a behavioural change activity program and motivational interviewing to increase physical activity in older adults.
Hypothesis 1:
Participants who receive a tailored behavioural change program will have higher physical activity levels compared to those who receive a ‘usual care’ education program.

Hypothesis 2:
Participants who undergo telephone counselling using motivational interviewing (MI) techniques will have higher physical activity levels compared to those who receive the same number of standard telephone contacts.

Hypothesis 3:
Participants who receive a tailored behavioural change program and telephone counselling with MI will have higher physical activity levels compared to those who received the other programs.

Hypothesis 4:
Increased levels of physical activity will be associated with greater health benefits such as increased fitness, reduced blood pressure, body weight, depression, stress, anxiety and improved psychological well-being.

Hypothesis 5:
Self efficacy will mediate the change in physical activity behaviour.
METHODS

Healthy, non smoking, sedentary, 50-80 year old men and women will be recruited from the community. Participants will be assessed on physical activity, fitness, body weight, blood pressure and psycho-social aspects of mental health such as stress, depression anxiety and well being at baseline, 6 and 12 months. They will be randomly assigned to a ‘usual care’ education program or a ‘behavioural change’ education program. Within each of these programs they will be further allocated to have standard telephone contacts or motivational interviewing (MI) telephone contacts. All participants will be asked to do 150 minutes/week of moderate physical activity for an initial 6 month intervention and a further 6 months of non contact.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28111 0
A/Prof Kay Cox
Address 28111 0
University of Western Australia School of Medicine and Pharmacology GPO Box X2213 Perth WA 6847
Country 28111 0
Australia
Phone 28111 0
+61 8 92240237
Fax 28111 0
Email 28111 0
[email protected]
Contact person for public queries
Name 11268 0
Kay Cox
Address 11268 0
University of Western Australia
School of Medicine and Pharmacology
GPO Box X2213 Perth
WA 6847
Country 11268 0
Australia
Phone 11268 0
+61 8 92240237
Fax 11268 0
+61 8 92240243
Email 11268 0
[email protected]
Contact person for scientific queries
Name 2196 0
Kay Cox
Address 2196 0
School of Medicine and Pharmacology
GPO Box X2213 Perth
WA 6847
Country 2196 0
Australia
Phone 2196 0
+61 8 92240237
Fax 2196 0
+61 8 92240243
Email 2196 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

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