Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000735257
Ethics application status
Approved
Date submitted
24/08/2009
Date registered
25/08/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Physical Activity and Nutrition for Seniors (PANS): Development and evaluation of a healthy lifestyle educational program.
Scientific title
Randomised Control Trial to evaluate the effect of a healthy lifestyle education program on nutrition, level of physical activity, perception of social support, overall physical and mental health and functional fitness in insufficiently active Seniors from low to middle socio-economic status (SES) groups.
Universal Trial Number (UTN)
Trial acronym
PANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prevention of overweight and obesity. 243569 0
Prevention of Type 2 Diabetes 243582 0
Prevention of cardiovascular diseases 243583 0
Prevention of some cancers 243584 0
Condition category
Condition code
Public Health 239865 239865 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention program will take place over 6months. The main intervention will be a booklet that will focus on healthy eating and physical activity, information on chronic diseases, physical activity and nutrition guidelines, goal setting, relapse prevention techniques.
Trained Research Assistants will conduct five group based face to face education sessions of 30 minutes each on nutrition, physical activity, goal setting and relapse prevention. Four sessions will take place over the first two months with the fifth session taking place in the last month of the intervention period.
Monthly newsletters providing supplementary information to booklet.
Fortnightly phonecalls.
Pedometers and resistance bands with information, demonstrations and materials to encourage usage.
Calendars to record physical activity and nutrition information.
Intervention code [1] 241169 0
Prevention
Intervention code [2] 241170 0
Lifestyle
Intervention code [3] 241171 0
Behaviour
Comparator / control treatment
Control group will be recruited at same time as the intervention group, but not receive any intervention. Their only participation will be via self completed questionnaires at baseline, 6 months and 12 months.
Control group
Active

Outcomes
Primary outcome [1] 240647 0
Improved level of physical activity - minutes of aerobic activity per week in the intervention group participants by 20%, compared to the control group participants. Data collected by self report questionnaires and analysed using SPSS.
Timepoint [1] 240647 0
Baseline, 6months, 12 months.
Primary outcome [2] 240651 0
A reduction in fat intake, increased fibre, increased fruit and vegetables consumption in the intervention group participants by 10%, compared to the control group participants. Data collected by self report questionnaires and analysed using SPSS.
Timepoint [2] 240651 0
Baseline, 6months, 12 months.
Secondary outcome [1] 257281 0
Reduction in waist/hip ratio in the intervention group participants by 10%, compared to the control group participants. Data collected by self report questionnaires and analysed using SPSS.
Timepoint [1] 257281 0
Baseline, 6months, 12 months.
Secondary outcome [2] 257282 0
Improved perception of social support in the intervention group participants by 10%, compared to the control group participants. Data collected by self report questionnaires and analysed using SPSS.
Timepoint [2] 257282 0
Baseline, 6months, 12 months.
Secondary outcome [3] 257286 0
Improved perception of overall physical health and mental health in the intervention group participants by 10%, compared to the control group participants. Data collected by self report questionnaires and analysed using SPSS.
Timepoint [3] 257286 0
Baseline, 6months, 12 months.

Eligibility
Key inclusion criteria
Inclusion criteria: Randomly selected sample of seniors from low and medium SES groups from the Perth metropolitan area “insufficiently active” (not achieving 30 minutes of moderate physical activity on at least 5 days/wk); aged 60 to 70 years old and healthy to the extent that participation in a low-stress physical activity program would not place them at risk.
Minimum age
60 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
If they receive a low score on the Readiness for Physical Activity Questionnaire (PARQ) and cannot gain medical clearance to participate in the program. If they are deemed to be ‘sufficiently active’ already (take part in at least 30 minutes of moderate-intensity physical activity on most days).

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)
The Survey Research Centre at Curtin University will match telephone numbers (of the 7200 names from the Federal Electoral Role) and make the initial contact. Allocation involved contacting the holder of the allocation schedule who was "off-site" and not involved in implementation of the trial on site. Prior to the initial contact by the Survey Centre, a postcard will be sent to subjects with information on the program and informing them they will receive a phone call within the next 2 weeks. During the initial contact, the purpose of the call will be explained and the caller will determine if the subject meets the selection criteria. The subjects will then be assigned to either the intervention group or the control group using a table of random numbers. A consent form and a self-completion questionnaire will then be sent to the willing subjects. They will be contacted by letter and 6 and 12 months to complete questionnaires. In accordance with ethics approval, participants will not be informed that the study is a Randomised Control Trial (RCT).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation conducted by programmer not involved in implementation of the trial on site (therefore not in contact with study participants) by using a randomisation table created by computer software.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237532 0
Government body
Name [1] 237532 0
National Health and Medical Research Council
Country [1] 237532 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
GPO 1421
CANBERRA ACT 2601
Country
Australia
Secondary sponsor category [1] 237007 0
University
Name [1] 237007 0
Curtin University
Address [1] 237007 0
Kent Street
Bentley WA 6102
Country [1] 237007 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243663 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 243663 0
Ethics committee country [1] 243663 0
Australia
Date submitted for ethics approval [1] 243663 0
Approval date [1] 243663 0
14/12/2008
Ethics approval number [1] 243663 0
186/2008

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

Contacts
Principal investigator
Name 30081 0
Address 30081 0
Country 30081 0
Phone 30081 0
Fax 30081 0
Email 30081 0
Contact person for public queries
Name 13328 0
Professor Peter Howat
Address 13328 0
Centre for Behavioural Research into Cancer Control, Curtin University,
GPO Box U1987,
Perth WA 6845
Country 13328 0
Australia
Phone 13328 0
+61 8 92661719
Fax 13328 0
+61 8 92661642
Email 13328 0
p.howat@curtin.edu.au
Contact person for scientific queries
Name 4256 0
Professor Peter Howat
Address 4256 0
Centre for Behavioural Research into Cancer Control, Curtin University,
GPO Box U1987,
Perth WA 6845
Country 4256 0
Australia
Phone 4256 0
+61 8 92661719
Fax 4256 0
+61 8 92661642
Email 4256 0
p.howat@curtin.edu.au

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
No additional documents have been identified.