Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000091505
Ethics application status
Approved
Date submitted
20/01/2015
Date registered
3/02/2015
Date last updated
15/02/2021
Date data sharing statement initially provided
15/02/2021
Date results provided
15/02/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating the health effects of volunteering by seniors
Scientific title
Investigating the physical and mental health effects of volunteering by seniors
Secondary ID [1] 286017 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical health 293980 0
Mental health 293985 0
Condition category
Condition code
Public Health 294280 294280 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Group:
Participants will be required to undertake a minimum of 60 minutes of volunteer work per week for a six-month period. Participants will be able to select the nature of the volunteer work, and will be provided with assistance by Volunteering WA to source potential volunteer activities.
All participants will be asked to keep a daily record of their physical activity and volunteering activities during the six-month period. This will be used to monitor adherence to the intervention.
Intervention code [1] 290999 0
Lifestyle
Comparator / control treatment
Participants will maintain their normal lifestyle or take on new activities as they see fit.
Control group
Active

Outcomes
Primary outcome [1] 294078 0
Physical health will be assessed using composite measures of resting heart rate, blood pressure, BMI, and waist girth.
Timepoint [1] 294078 0
Baseline (0 months) and post-intervention (6 months)
Primary outcome [2] 294157 0
Physical function will be assessed using a composite of standard measures including chair rise to standing, 400m walk, 6m backward walk, 6m normal pace walk and 6m fast pace walk.
Timepoint [2] 294157 0
Baseline (0 months) and post-intervention (6 months)
Primary outcome [3] 294158 0
Muscle strength will be assessed using composite one repetition maximum in the leg press, seated row and leg extension.
Timepoint [3] 294158 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [1] 312481 0
Physical activity will be assessed by steps taken and sedentary time, measured using pedometers and Actigraph monitors.
Timepoint [1] 312481 0
Pedometers will be worn for a 6 month period from Baseline (0 months) to post-intervention (6 months). Actigraph monitors will be worn for 7 consecutive days prior to commencing the study (0 months) and for 7 consecutive days prior to completing the study (6 months).
Secondary outcome [2] 312482 0
Psychological well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale.
Timepoint [2] 312482 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [3] 312483 0
Depression will be assessed using the Center for Epidemiologic Studies Depression Scale.
Timepoint [3] 312483 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [4] 312484 0
Self-esteem will be assessed until the Rosenberg Self-Esteem Survey.
Timepoint [4] 312484 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [5] 312485 0
Quality of life will be assessed using the Global Quality of Life Scale.
Timepoint [5] 312485 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [6] 312486 0
Life satisfaction will be assessed using a single-item. All things considered, how satisfied are you with your life as a whole these days? This item has been adopted in the World Values Survey. It has also been listed in the 2013 OECD Guidelines as a suggested measure for assessing life satisfaction.
Timepoint [6] 312486 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [7] 312487 0
Personal growth will be assessed using the Personal Growth subscale of Ryff's Pyschological Well-Being Scale.
Timepoint [7] 312487 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [8] 312488 0
Purpose in life will be assessed using the Purpose in Life subscale of Ryff's Psychological Well-Being Scales.
Timepoint [8] 312488 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [9] 312489 0
Social support will be assessed using the Social Provisions Scale.
Timepoint [9] 312489 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [10] 312490 0
Self-efficacy will be assessed using the Generalized Self-Efficacy Scale.
Timepoint [10] 312490 0
Baseline (0 months) and post-intervention (6 months)
Secondary outcome [11] 312491 0
Attitudes to volunteering will be assessed via an open-ended interview.
Timepoint [11] 312491 0
Baseline (0 months) and post-intervention (6 months)

Eligibility
Key inclusion criteria
Retired/non-employed individuals in good health aged 60+ years.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Engaged in volunteering activities during the previous 12 months.

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)
Central randomisation by computer. Written informed consent will be required prior to any testing or randomisation. Subjects who dropout prior to completing any baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by a randomisation table created by a computer sequence. Randomisation is at the level of the individual participant and will be stratified by sex, age and socioeconomic variables.
Masking / blinding
Blinded (masking 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
10/12/2014
Actual
10/12/2014
Date of last participant enrolment
Anticipated
Actual
15/06/2016
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
400
Accrual to date
Final
445
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290612 0
Government body
Name [1] 290612 0
Australian Research Council
Country [1] 290612 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 289298 0
Individual
Name [1] 289298 0
Professor Simone Pettigrew
Address [1] 289298 0
Curtin University Kent St Bentley, WA 6102
Country [1] 289298 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307873 0
Curtin University
Ethics committee address [1] 307873 0
Ethics committee country [1] 307873 0
Australia
Date submitted for ethics approval [1] 307873 0
Approval date [1] 307873 0
27/02/2014
Ethics approval number [1] 307873 0
HR21_2014

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

Contacts
Principal investigator
Name 47614 0
Prof Simone Pettigrew
Address 47614 0
Curtin University Kent Street Bentley, WA 6102.
Country 47614 0
Australia
Phone 47614 0
+618 92667990
Fax 47614 0
Email 47614 0
[email protected]
Contact person for public queries
Name 47615 0
Simone Pettigrew
Address 47615 0
Curtin University Kent Street Bentley, WA 6102.
Country 47615 0
Australia
Phone 47615 0
+618 92667990
Fax 47615 0
Email 47615 0
[email protected]
Contact person for scientific queries
Name 47616 0
Simone Pettigrew
Address 47616 0
Curtin University Kent Street Bentley, WA 6102.
Country 47616 0
Australia
Phone 47616 0
+618 92667990
Fax 47616 0
Email 47616 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocolPettigrew, S., Jongenelis, M., Newton, R. U., Warburton, J., and Jackson, B. (2015). Research protocol for a randomized controlled trial of the health effects of volunteering for seniors. Health and Quality of Life Outcomes, 13, 74-81, doi: 10.1186/s12955-015-0263-z. Impact factor: 2.318.   


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Pettigrew, S., Jongenelis, M., Jackson, B., Warbur... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseResearch protocol for a randomized controlled trial of the health effects of volunteering for seniors.2015https://dx.doi.org/10.1186/s12955-015-0263-z
N.B. These documents automatically identified may not have been verified by the study sponsor.