Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000468729
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
25/03/2022
Date last updated
28/01/2024
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study on the impact of outdoor gardening on physical function and socialisation in older adults.
Scientific title
Pilot study of a quasi-experiment to explore the impact of outdoor gardening on physical and psychosocial functioning in older adults
Secondary ID [1] 306585 0
R-LHR-2022-184098
Universal Trial Number (UTN)
U1111-1275-2440
Trial acronym
AWinOG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical function 325478 0
Loneliness 325479 0
Condition category
Condition code
Public Health 322862 322862 0 0
Other public health
Mental Health 322931 322931 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants, in groups of ten, will engage in weekly gardening activities over 12 months at a community garden. The participants will be working in pairs or a smaller group (depending on their ability) supervise by the manager of the community garden. The gardening activities will last between 2-3 hours in the morning, including a share morning tea/light lunch where the group comes together to socialise.
The gardening activities are general low-risk gardening activities (weeding, watering existing plants, planting, potting, transplanting seedlings or plants etc) with an opportunity to increase gardening activities intensity (digging, spading, filling garden, composting etc) over time.
A research study co-ordinator will also be on-site to assist participants with recording their activities, record attendance and feedback from the participants about the ease/challenges including documentation of the activities.
Intervention code [1] 323012 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330649 0
Feasibility of recruitment older Maori and Pacific people aged 50+,
Recruitment strategies will be documented and recruitment rate determine with audit of recruitment log,
Timepoint [1] 330649 0
Recruitment rate will be determined at 6 months after the opening of recruitment.
Primary outcome [2] 330772 0
Retention rate will be determined using the attendance log.
Timepoint [2] 330772 0
Retention rate will be determined 12 months after enrollment into the study.
Secondary outcome [1] 407081 0
Gardening activities (self-recorded diary)
Timepoint [1] 407081 0
Baseline, 6 months and 12 months after starting intervention
Secondary outcome [2] 407247 0
Physical activity (Physical Activity Scale for the Elderly)
Timepoint [2] 407247 0
Baseline, 6 months and 12 months after starting intervention
Secondary outcome [3] 407248 0
Cognitive function (Mini-Addenbrooke’s Cognitive Examination)
Timepoint [3] 407248 0
Baseline, 6 months and 12 months after starting intervention
Secondary outcome [4] 407249 0
Quality of life (Global self-rated health)
Timepoint [4] 407249 0
Baseline, 6 months and 12 months after starting intervention
Secondary outcome [5] 407250 0
Loneliness (De Jong Gierveld 6-item scales for emotional and social loneliness)
Timepoint [5] 407250 0
Baseline, 6 months and 12 months after starting intervention
Secondary outcome [6] 407251 0
Short physical performance battery
Timepoint [6] 407251 0
Baseline, 6 months and 12 months after starting intervention
Secondary outcome [7] 407514 0
Chair sit-and-reach flexibility test
Timepoint [7] 407514 0
Baseline, 6 months and 12 months after starting intervention
Secondary outcome [8] 407879 0
Grip strength using dynamometer
Timepoint [8] 407879 0
Baseline, 6 months and 12 months after starting intervention

Eligibility
Key inclusion criteria
Community dwelling adults aged 50 years and above
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Terminally ill or having advanced dementia as judged by the GP or Maori health provider,

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
With a sample size of 40 study participants and 80% power, we expect to see a moderate effect size (0.44). In a cross-section analysis of the Health and Retirement Study with equal proportion of gardeners and non-gardeners, the effect size for gait speed and functional limitations between the group was 0.36 and 0.31 respectively (Journal of Aging Physical Activity. 2012;20(1):15-31).

Recruitment of lonely/socially isolated older people will be summarised in a descriptive table and retention rate will be determined from the weekly attendee records.

Repeated measures generalised linear models will be used to estimate the effect of the AWinOG programme at different time points. Potential confounders (age, socioeconomic status, health habits) will be adjusted for in regression models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2022
Actual
26/04/2022
Date of last participant enrolment
Anticipated
30/06/2022
Actual
31/10/2022
Date of last data collection
Anticipated
14/07/2023
Actual
30/10/2023
Sample size
Target
40
Accrual to date
Final
44
Recruitment outside Australia
Country [1] 24636 0
New Zealand
State/province [1] 24636 0
Northland

Funding & Sponsors
Funding source category [1] 310915 0
Government body
Name [1] 310915 0
Te Tahua Rangahau Hauoratanga, Lottery Health Research
Country [1] 310915 0
New Zealand
Primary sponsor type
Government body
Name
Te Tahua Rangahau Hauoratanga, Lottery Health Research
Address
Auckland UniServices Ltd.,
Level 10, 49 Symonds St, Auckland, New Zealand

c/- The University of Auckland, Private Bag 92019,
Victoria St West, Auckland 1142, New Zealand
Country
New Zealand
Secondary sponsor category [1] 312201 0
None
Name [1] 312201 0
Address [1] 312201 0
Country [1] 312201 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310475 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 310475 0
Ethics committee country [1] 310475 0
New Zealand
Date submitted for ethics approval [1] 310475 0
27/01/2022
Approval date [1] 310475 0
11/02/2022
Ethics approval number [1] 310475 0
2022 EXP 12123

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

Contacts
Principal investigator
Name 117798 0
Dr Ruth Teh
Address 117798 0
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 3, Room 3118
28 PARK AVE
GRAFTON
AUCKLAND 1023
New Zealand
Country 117798 0
New Zealand
Phone 117798 0
+64 99237517
Fax 117798 0
Email 117798 0
[email protected]
Contact person for public queries
Name 117799 0
Ruth Teh
Address 117799 0
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 3, Room 3118
28 PARK AVE
GRAFTON
AUCKLAND 1023
New Zealand
Country 117799 0
New Zealand
Phone 117799 0
+64 99237517
Fax 117799 0
Email 117799 0
[email protected]
Contact person for scientific queries
Name 117800 0
Ruth Teh
Address 117800 0
University of Auckland
M&HS BUILDING 507 - Bldg 507
Level 3, Room 3118
28 PARK AVE
GRAFTON
AUCKLAND 1023
New Zealand
Country 117800 0
New Zealand
Phone 117800 0
+64 99237517
Fax 117800 0
Email 117800 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study needs to consult with the local Maori communities


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15277Study protocol    Manuscript in draft
15278Ethical approval    Ethics reference: 2022 EXP 12123, dated 11 Feb 202... [More Details]



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.