ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

Nil

Universal Trial Number (UTN)

U1111-1136-3842

Trial acronym

RVPANS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

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]

Behaviour

Intervention code [2]

Prevention

Intervention code [3]

Lifestyle

Comparator / control treatment

No treatment

Control group

Active

Outcomes

Primary outcome [1]

Level of physical activity

Timepoint [1]

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]

Sedentary activity/behaviour

Timepoint [2]

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]

Nutrition

Timepoint [3]

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]

Body composition

Timepoint [1]

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]

Blood pressure

Timepoint [2]

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]

Perception of overall physical and mental health

Timepoint [3]

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]

Physical and social environmental changes

Timepoint [4]

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]

University

Name [1]

Curtin University

Address [1]

Kent Street
Bentley
Perth
Western Australia 6845

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Kent Street
Bentley
Perth
Western Australia 6845

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

Office of Research and Development Human Research Ethics Committee

Ethics committee address [1]

Curtin University
Kent Street
Bentley
Perth 
WA 6845

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/10/2012

Approval date [1]

Ethics approval number [1]

4327

Summary

Brief summary

Physical activity levels of Australia’s ageing population are declining, while their rates of overweight and obesity are increasing. Physical activity and a healthy diet are recognised as important in maintaining a healthy weight and preventing chronic disease. The retirement village provides a unique setting to access and engage with this older target group, to test the effectiveness of strategies to increase levels of physical activity, improve nutrition and maintain a healthy weight. 
      This large scale RCT will evaluate a physical activity, nutrition and healthy weight management intervention for adults aged 60-75 years residing in retirement villages that will ultimately reduce chronic disease (e.g. diabetes, cardiovascular disease, and some cancers).
       By the end of the intervention we anticipate that there will be a significant improvement in physical activity (time/intensity) and dietary behaviours (10% reduction in dietary fat; 10%fibre intake; 10% increase in fruit/vegetables consumption), and body composition of the intervention group participants, compared to the control group participants.

Trial website

Nil

Trial related presentations / publications

Nil

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Annie Holt

Address

School of Public Health
Building 400(469a)
Curtin University
Kent Street
Bentley
Perth WA 6845

Country

Australia

Phone

61 08 92669290

Fax

nil

a.holt@curtin.edu.au

Contact person for scientific queries

Name

Dr Jonine Jancey

Address

School of Public Health
Building 400
Curtin University
Kent Street
Bentley
Perth WA 6845

Country

Australia

Phone

61 08 92663807

Fax

nil

j.jancey@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

Source	Title	Year of Publication	DOI
Embase	Effects of a physical activity and nutrition program in retirement villages: A cluster randomised controlled trial.	2017	https://dx.doi.org/10.1186/s12966-017-0543-6

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically