Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001168842
Ethics application status
Not yet submitted
Date submitted
26/10/2012
Date registered
2/11/2012
Date last updated
2/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Controlled Trial of a Physical Activity and Nutrition Program in Retirement Villages
Scientific title
In residents/older adults (60-75y) in retirement villages, is a physical activity and nutrition intervention more effective than no intervention in increasing levels of physical activity and improving nutrition?
Secondary ID [1] 281444 0
Nil
Universal Trial Number (UTN)
U1111-1136-3842
Trial acronym
RVPANS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 287705 0
Condition category
Condition code
Diet and Nutrition 288092 288092 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical activity and nutrition intervention
PHYSICAL ACTIVITY
(a) a minimum of 150 minutes of physical activity per week
(b) over a period of six months
(c) home-based program administered by an exercise physiologist
NUTRITION
(a) a reduction in fat intake, an increase in fruit and vegetable consumption, an increase in fibre intake
(b) over a period of six months
(c) home-based program administered bya qualified dietitcian
Intervention code [1] 285950 0
Behaviour
Intervention code [2] 285994 0
Prevention
Intervention code [3] 285995 0
Lifestyle
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 288252 0
Level of physical activity
Timepoint [1] 288252 0
A 10% increase in minutes of physical activity per week measured through accelerometry and self-reported survey (IPAQ) assessed over a period of 1 week at baseline prior to intervetnion assessment and 6 months post-test
Primary outcome [2] 288253 0
Sedentary activity/behaviour
Timepoint [2] 288253 0
A 10% decrease in sedentary behavour measured thorugh accelreometry and self-reported survey (IPAQ) assessed over 1 week measured at baseline prior to intervention commencement and 6 months post-test
Primary outcome [3] 288297 0
Nutrition
Timepoint [3] 288297 0
A 10% decrease in fat intake, a 10% increase in fruit, vegetable and fibre intake measured through the Australian Cancer Council DQES - dietary questionnaire for epidemiological studies assessed at baseline prior to intervention commencement and post-test 6 months
Secondary outcome [1] 299698 0
Body composition
Timepoint [1] 299698 0
A 10% improvement in Bodymass index (BMI) measured by weight/height (2) measured at baseline prior to intervetnion commencement and at post test - 6 months
Secondary outcome [2] 299779 0
Blood pressure
Timepoint [2] 299779 0
A 10% improvement in distolic blood pressure measured through sphygmamometer assessed at baseline prior to intervetnion commencement and at post-test (6 months)
Secondary outcome [3] 299780 0
Perception of overall physical and mental health
Timepoint [3] 299780 0
A 10% improvement in self-efficacy for exericse and nutrition measured by SF8 Health survey evaluated at baseline prior to intervention commencement and at post-test (6 months)
Secondary outcome [4] 299781 0
Physical and social environmental changes
Timepoint [4] 299781 0
A 10% improvement as measured by the Environmental Assessment Tool (EAT) developed for residential settings evaluated at baseline prior to intervention and post-test (6 months)

Eligibility
Key inclusion criteria
A total of 400 participants will be recruited from 20 retirement villages (intervention group villages n=10: control group villages n=10). Participants will be required to be aged 60 to 75 years; insufficiently active (not achieving the recommended level of 150 minutes of moderate physical activity per week); on no special diet; not involved in another special physical activity program, and able to participate in a low-stress physical activity program with minimal risk to overall health and wellbeing. Couples may enter the control or intervention group together but cannot be allocated to separate groups (risk of contamination).The program is for the age group 60-75 y. The prevalence of underweight (<18.5 BMI) is low in this age group. However, at risk participants identified will be referred to their GP for follow- up and excluded from the study.
Minimum age
60 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A Physical Activity Readiness (PAR_Q)questionnaire and a medical clearance form will be completed on enrollment. This will allow for those deemed high risk to be eliminated from the study.

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)
Potential participants in the 20 retirement villages will be sent a postcard explaining the intervention project, their rights and confidentiality details. They will be asked to sign and return the postcard if they are willing to participate in the research. This procedure has been used by the Investigators to enhance recruitment in previous projects with this age group. There will be a staggered entry into the intervention of 50 participants per week over a 3-month timeframe. The intervention group (n=200) will receive the intervention program. Requests to complete the self-administered questionnaire at baseline and 6-months will be the only contact the control group will receive from project staff. Incentives will be provided to all participants as used in such previous research.The method of allocation concealment will be done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomised 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
28/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286211 0
University
Name [1] 286211 0
Curtin University
Country [1] 286211 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street
Bentley
Perth
Western Australia 6845
Country
Australia
Secondary sponsor category [1] 285021 0
None
Name [1] 285021 0
Address [1] 285021 0
Country [1] 285021 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288287 0
Office of Research and Development Human Research Ethics Committee
Ethics committee address [1] 288287 0
Ethics committee country [1] 288287 0
Australia
Date submitted for ethics approval [1] 288287 0
05/10/2012
Approval date [1] 288287 0
Ethics approval number [1] 288287 0
4327

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

Contacts
Principal investigator
Name 34878 0
Address 34878 0
Country 34878 0
Phone 34878 0
Fax 34878 0
Email 34878 0
Contact person for public queries
Name 18125 0
Annie Holt
Address 18125 0
School of Public Health
Building 400(469a)
Curtin University
Kent Street
Bentley
Perth WA 6845
Country 18125 0
Australia
Phone 18125 0
61 08 92669290
Fax 18125 0
nil
Email 18125 0
[email protected]
Contact person for scientific queries
Name 9053 0
Dr Jonine Jancey
Address 9053 0
School of Public Health
Building 400
Curtin University
Kent Street
Bentley
Perth WA 6845
Country 9053 0
Australia
Phone 9053 0
61 08 92663807
Fax 9053 0
nil
Email 9053 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
EmbaseEffects of a physical activity and nutrition program in retirement villages: A cluster randomised controlled trial.2017https://dx.doi.org/10.1186/s12966-017-0543-6
N.B. These documents automatically identified may not have been verified by the study sponsor.