Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001224112
Ethics application status
Approved
Date submitted
16/08/2019
Date registered
5/09/2019
Date last updated
2/09/2022
Date data sharing statement initially provided
5/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Strong culture, healthy lifestyles: an afterschool Aboriginal cultural activity program to promote healthy lifestyles in children
Scientific title
An afterschool Aboriginal cultural activity program to promote healthy lifestyles in Aboriginal children and their siblings
Secondary ID [1] 299036 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
physical activity 314049 0
healthy eating 314050 0
spiritual health 314051 0
Condition category
Condition code
Diet and Nutrition 312438 312438 0 0
Obesity
Public Health 312439 312439 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The afterschool cultural activity program is a 10-week program delivered to Aboriginal children and their siblings delivered by two local Aboriginal people (known as mentors; one male and one female) who hold the appropriate cultural knowledge and are identified by local Elders as being appropriate program leaders. In addition, visiting Aboriginal mentors also attend the program each to share community-specific knowledge that relate to the programmed activities (e.g. community-specific dances, stories, bush tucker). A program coordinator for each community is employed to oversee the running of the program. The mentors and program coordinators are required to hold a Working with Children Check and skills in engaging children.

The program runs for two afternoons for 10-weeks (3:30-5:30pm). Each afternoon, the children are provided with healthy afternoon snacks. The program agenda is designed by the local Aboriginal mentors and Elders. The activities chosen in the agenda are specific to each participating community to reflect specific community cultural knowledge. Activities are developed to reinforce and build on the children’s connection to Country and promote healthy lifestyle behaviours, such as physical activity in the local natural landscapes (e.g. fishing, bushwalks, dancing), learning and celebrating culture through song and dance, and preparation and eating of local native foods.

Participants will receive the following program resources:
- pedometers to monitor their steps during the program
- cameras to document their cultural learning journey

The program is delivered either in a community centre or on school grounds (the appropriate location is identified by the Elders and Mentors). Also, participants engage in excursions on Country to places of cultural importance that relate to the program agenda. Transport is provided where necessary.

Program adherence is assessed via:
- attendance records at each session (taken by the mentors at the start of each session)
- a record of activities completed at each session and if necessary, reasons for why activities are not completed or modified from the planned agenda (completed by the mentors)
- direct observation of two randomly selected sessions using a checklist developed specifically for the study (completed by a research data collector from the University of Wollongong with appropriate training in direct observation).

The direct observation and record of activities are compared with the planned agenda to determine how much of the program is delivered as planned.

If it is identified that the program adherence is poor, the following strategy will be applied:
- Additional training for the Mentors if required (led by the Program Coordinator, and supported by members of the research team)
Intervention code [1] 315309 0
Lifestyle
Intervention code [2] 315310 0
Behaviour
Comparator / control treatment
There is no comparator group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321086 0
Feasibility of the afterschool cultural program - assessed by a study specific questionnaire (recruitment rates of children, recruitment rates of mentors, % of program delivered, secondary outcomes checklist).
Timepoint [1] 321086 0
10-weeks post baseline
Primary outcome [2] 321186 0
Acceptability of afterschool program - assessed using a study specific questionnaire (program attendance, participant retention rate, mean enjoyment score).
Timepoint [2] 321186 0
10-weeks post baseline
Secondary outcome [1] 373936 0
Time spent in total physical activity (minutes in light, moderate and vigorous physical activity) - measured using GT3X+ Actigraph accelerometers for one week where at least 2 days are recorded.
Timepoint [1] 373936 0
Baseline and 10-weeks post baseline
Secondary outcome [2] 373947 0
Dietary intake (children) - measured with the 24-hour Food Recall for two days. For children under the age of 9, the recalls are parent reported. For children over the age of 9, the recalls are self-reported.
Timepoint [2] 373947 0
Baseline and 10-weeks post baseline
Secondary outcome [3] 373949 0
Adiposity (body mass index) (children) - measurements of height and weight are taken using SECA Portable Stadiometer 217 and the SECA Scales 874, respectively. Body Mass Index is calculated using the standard formula of weight in kilograms divided by the square of height in meters.
Timepoint [3] 373949 0
Baseline and 10-weeks post baseline
Secondary outcome [4] 373960 0
Food security (parents) - measured using a two-item question from the Australian Bureau of Statistics, Aboriginal and Torres Strait Islander Health Survey
Timepoint [4] 373960 0
Baseline and 10-weeks post baseline
Secondary outcome [5] 373961 0
School attendance - parent-reported number of days missed per school term
Timepoint [5] 373961 0
Baseline and 10-weeks post baseline
Secondary outcome [6] 373962 0
Sleep (children) - parent-reported usual number of hours of sleep per night
Timepoint [6] 373962 0
Baseline and 10-weeks post baseline
Secondary outcome [7] 373963 0
Afterschool activities - parent-reported number of days per week a child attends an afterschool activity
Timepoint [7] 373963 0
Baseline
Secondary outcome [8] 373964 0
Screentime behaviours - parent-reported and measured using three items about recreational screentime rules, number of hours per typical weekday spent in recreational screentime and number of hours per tupical weekend spent in recreational screentime.
Timepoint [8] 373964 0
Baseline and 10-weeks post baseline
Secondary outcome [9] 373965 0
Cultural connectedness (children) - measured using a two-item survey from the Longitudinal Study of Indigenous Children and yarning circles.
Timepoint [9] 373965 0
Baseline and 10-weeks post baseline
Secondary outcome [10] 373966 0
Spiritual well-being - assessed through photography and yarning. Children take pictures of things that are important to them and these are then used in one-on-one interviews to gain a deeper understanding of their spiritual well-being
Timepoint [10] 373966 0
10-weeks post baseline
Secondary outcome [11] 373967 0
School-related behaviours - measured through the Strengths and Difficulties Questionnaires completed by parents and the school teacher.
Timepoint [11] 373967 0
Baseline and 10-weeks post baseline
Secondary outcome [12] 374217 0
Sedentary time during the afterschool period (children) - measured using GT3X+ Actigraph accelerometers for one week where at least 2 days are recorded.
Timepoint [12] 374217 0
Baseline and 10-weeks post baseline
Secondary outcome [13] 374218 0
Home-related behaviours - measured through the Strengths and Difficulties Questionnaires completed by parents and the school teacher.
Timepoint [13] 374218 0
Baseline and 10-weeks post baseline

Eligibility
Key inclusion criteria
- Children aged 5-13 years
- Identify as being Aboriginal or Torres Strait Islander or are a sibling of a Aboriginal Torres Strait Islander child
- Parents of children who are aged 5-13 years and identify as being Aboriginal or Torres Strait Islander
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None identified

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
The feasibility of implementation will be analysed using descriptive statistics, and thematic qualitative analysis to identify key themes around spiritual well-being, cultural connectedness and lessons learnt and strategies for improvement of the program. Other quantitative data will be analysed using paired t-tests and Mann-Whitney U tests to determine changes in health outcomes. Food intake analysis will be aided by FoodWorks nutrient analysis software using the AUSNUT 2011-12 food consumption database.

As this was a pilot study to primarily assess the feasibility and acceptability, a sample size calculation was not applicable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
20/07/2016
Date of last participant enrolment
Anticipated
23/12/2022
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
111
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303572 0
University
Name [1] 303572 0
University of Wollongong, Global Challenges
Country [1] 303572 0
Australia
Funding source category [2] 303576 0
Government body
Name [2] 303576 0
NSW Health
Country [2] 303576 0
Australia
Funding source category [3] 305019 0
Charities/Societies/Foundations
Name [3] 305019 0
Illawarra Health and Medical Research Institute
Country [3] 305019 0
Australia
Primary sponsor type
Individual
Name
Dr Rebecca Stanley
Address
Early Start
School of Health and Society
Faculty of Humanities, Social Sciences and Arts
University of Wollongong
Northfields Ave
Wollongong NSW 2500
Country
Australia
Secondary sponsor category [1] 303658 0
None
Name [1] 303658 0
Address [1] 303658 0
Country [1] 303658 0
Other collaborator category [1] 280909 0
Other Collaborative groups
Name [1] 280909 0
Cullunghutti Aboriginal Child and Family Centre
Address [1] 280909 0
PO Box 4103
East Nowra NSW 2541
Country [1] 280909 0
Australia
Other collaborator category [2] 280910 0
Other Collaborative groups
Name [2] 280910 0
Ulladulla Aboriginal Land Council
Address [2] 280910 0
66 Deering St
Ulladulla NSW 2539
Country [2] 280910 0
Australia
Other collaborator category [3] 280911 0
Other Collaborative groups
Name [3] 280911 0
Jerrinja Aboriginal Community
Address [3] 280911 0
Orsova Parade, Orient Point NSW 2540
Country [3] 280911 0
Australia
Other collaborator category [4] 281206 0
Other Collaborative groups
Name [4] 281206 0
Illawarra Aboriginal Medical Service
Address [4] 281206 0
150 Church St
Wollongong NSW 2500
Country [4] 281206 0
Australia
Other collaborator category [5] 281904 0
Government body
Name [5] 281904 0
National Indigenous Australians Agency
Address [5] 281904 0
National Indigenous Australians Agency
PO Box 2191
Canberra ACT 2600
Country [5] 281904 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304102 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 304102 0
Ethics committee country [1] 304102 0
Australia
Date submitted for ethics approval [1] 304102 0
29/05/2015
Approval date [1] 304102 0
30/07/2015
Ethics approval number [1] 304102 0
HE15/240

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

Contacts
Principal investigator
Name 95814 0
Dr Rebecca Stanley
Address 95814 0
Early Start, School of Health and Society, Faculty of Humanities, Social Sciences and Arts, University of Wollongong Northfields Ave Wollongong NSW 2500
Country 95814 0
Australia
Phone 95814 0
+61 2 4221 5288
Fax 95814 0
Email 95814 0
[email protected]
Contact person for public queries
Name 95815 0
Rebecca Stanley
Address 95815 0
Early Start, School of Health and Society, Faculty of Humanities, Social Sciences and Arts, University of Wollongong Northfields Ave Wollongong NSW 2500
Country 95815 0
Australia
Phone 95815 0
+61 2 4221 5288
Fax 95815 0
Email 95815 0
[email protected]
Contact person for scientific queries
Name 95816 0
Rebecca Stanley
Address 95816 0
Early Start, School of Health and Society, Faculty of Humanities, Social Sciences and Arts, University of Wollongong Northfields Ave Wollongong NSW 2500
Country 95816 0
Australia
Phone 95816 0
+61 2 4221 5288
Fax 95816 0
Email 95816 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 participating communities own the data and hold the authority to share the information if they wish.


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
Dimensions AIStrong culture, healthy lifestyles: a mixed methods feasibility study for a co-created afterschool cultural programme for Australian Aboriginal children2024https://doi.org/10.1186/s40814-023-01422-y
N.B. These documents automatically identified may not have been verified by the study sponsor.