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Trial registered on ANZCTR


Registration number
ACTRN12624001456549p
Ethics application status
Submitted, not yet approved
Date submitted
19/11/2024
Date registered
16/12/2024
Date last updated
16/12/2024
Date data sharing statement initially provided
16/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Personalised pair-based physical activity promotion intervention for autistic adults: A trial evaluating feasibility and acceptability.
Scientific title
Personalised Dyadic Physical Activity Promotion Intervention for Autistic Adults: A Pilot Trial Evaluating Feasibility and Acceptability
Secondary ID [1] 313425 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insufficient physical activity 335799 0
Autism 335911 0
Condition category
Condition code
Physical Medicine / Rehabilitation 332376 332376 0 0
Other physical medicine / rehabilitation
Mental Health 332502 332502 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention Overview:

- The intervention consists of a 12-week personalised physical activity (PA) program designed for dyads, where each autistic adult invites a partner from their social network (family, friends, or support workers) to participate as their PA partner. The PA partner will provide social support and assist with action planning.

- The intervention aims to (1) improve PA accumulation to at least 75 minutes of vigorous PA or 150 minutes of moderate PA, or a combination of both each week, (2) reduce sedentary behaviour (SB, e.g., sitting, lying, watching TV, playing video games) accumulation each week, and (3) improve motivation for PA. These outcomes will be measured using accelerometers and self-report questionnaires.

- The intervention will be delivered by a PhD student at Curtin University.

- Intervention Components: The intervention will incorporate components from the Behaviour Change Wheel (BCW), specifically focusing on education, enablement, persuasion, and incentivisation. The intervention will utilise various behaviour change techniques, including problem-solving, instruction on performing the behaviour, social support, action planning, feedback, social reward, objects, self-monitoring, verbal persuasion, and information about health, emotional and social consequences. Autistic participants will receive an Intervention Manual (developed by the researchers), and their partners will receive a Partner Guide (within the Intervention Manual) outlining the content and instructions for the program.

- Intervention core components: Over 12 weeks, the autistic adults and their partners will collaborate to choose, plan, schedule and perform PA (e.g., walking, cycling, hiking...) together in person. The location, frequency and duration of PA sessions will be determined by the dyad. To enhance engagement and adherence, the research team will provide personalized prompts, reminders, achievement recognition, and support via online messages through WhatsApp, a platform recommended by the advisory group of autistic people for its acceptability.

- Performance Monitoring: Every two weeks, each pair will meet with the research team in person or online for a performance review (20 minutes). During these meetings, pairs will reflect on their PA and sedentary behaviour (SB) levels and work with the research team to identify barriers and develop solutions to improve or maintain their progress.

- Self-Monitoring Tools: Autistic adults will wear Fitbit 3 devices throughout the 12-week intervention to self-monitor their PA and SB.

- Objective Measurement: Autistic participants will also wear the SENS accelerometer device during three seven-day periods: weeks 0 (pre-intervention week), week 7 (mid-intervention week), and week 13 (post-intervention week) to track their PA and SB objectively. SENS is a compact, discreet wireless activity sensor designed for attachment to the thigh using an adhesive patch. It measures the duration and intensity of physical activity (PA), sleep time and quality, and resting and standing time. Developed for use in both healthcare and research settings, it offers versatile and reliable applications.

Intervention timeline:

Week 0 (Pre-Intervention):
- Participants will attend an in-person introductory session (1 hour) on the Curtin campus with the researchers to review the intervention protocol and complete pre-intervention measurements, including the International Physical Activity Questionnaire (IPAQ) and the Behavioral Regulation in Exercise Questionnaire-2 (BREQ-3).
- During this session, participants will receive the Sens device (accelerometer) and be instructed to wear it for the entire week to track baseline SB, PA duration, and intensity. They will be reminded to connect the Sens device to the Motus app daily for data transfer and to return it using a prepaid envelope at the end of Week 0.
- The researchers will provide educational materials and training to ensure an understanding of proper general physical activity techniques, including the importance of warm-ups and cool-downs.
- Participants will be invited to join a WhatsApp group chat, which will serve as an online social support hub. The group chat will allow participants to receive any communications, such as reminders, prompts, and achievement announcements from the research team.
- Participants will schedule the Week 1 online workshop with the researchers.

Week 1:
- An online workshop (1 hour and 30 minutes) will be held to educate participants on the content of the intervention, enhance their understanding and motivation for PA, and address any misconceptions about PA. The workshop will cover topics such as the health benefits of PA, the consequences of SB, how to share public gym/PA facilities, easy and fun PA (e.g., walking, dancing, cycling), problem-solving strategies, and co-planning PA activities. All educational content will be delivered by the researcher team.
- The researchers and dyad will discuss effective communication and conflict resolution to manage potential interpersonal challenges.
- Clear guidelines and training will outline the roles, responsibilities, and expectations for mutual respect within the dyad. This is the only training that the partner will receive for their role. The training will be provided by the researcher team during the week 1 online work shop.

Weeks 1 to 12:
- At the start of Weeks 1, 3, 5, 7, 9, and 11, participants will co-plan their PA activities for the next two weeks using action planning templates in their Intervention Manuals. They will send a copy of their plan to the research team via WhatsApp, and the PhD student will send personalised PA reminders according to their plan. The partner will provide daily encouragement to the autistic adult to complete their planned PA, and both can share achievements in the group chat to motivate each other.

- The PhD student will send daily motivational messages and prompts to the group chat, encouraging PA and reducing SB (e.g., “Let’s walk around the neighbourhood for 5 minutes” or “Turn on your favourite song and dance”).

- At the start of weeks 3, 5, 7, 9, 11, and 13, each pair will participate in a quick online feedback (weeks 7 and 13 will be done offline to deliver the SENS devices) meeting (20 minutes) with the PhD student. During these meetings, participants will reflect on their PA and SB levels from the previous two weeks, identify barriers, and discuss solutions to maintain or improve their PA levels. The PhD student will congratulate participants who meet their PA goals and provide additional support or guidance as needed.

- The autistic adult will continuously wear the Sens device during Weeks 7 (mid-intervention) and 13 (post-intervention) and a Fitbit 3 device throughout the 12 weeks to monitor PA and SB. In their Intervention Manual, they will log the types of PA performed, total minutes of physical activity (Active Zone Minute data from Fitbit), and total minutes of SB each week (Stationary hours data from Fitbit).

- The participants will complete the IPAQ and BREQ-3 in the week 7 review meeting.

Week 13 (Post-Intervention):
- At the beginning of Week 13, the Sens device will be distributed again in an in-person meeting. Participants will wear it for the week to track their PA and SB levels.
- Participants will complete post-intervention measurements online, including the IPAQ, BREQ-3, and acceptability surveys.
- At the end of Week 13, participants will return the Sens device using the prepaid envelope provided during the Week 13 meeting.
- Adherence to the intervention: Measured by checking the checklists and logbook data from participants' Intervention Manuals, assessed at weeks 7 and 13. Also, Regular check-ins via WhatsApp and feedback meetings will monitor participants’ adherence.
Intervention code [1] 329991 0
Behaviour
Intervention code [2] 330068 0
Treatment: Other
Comparator / control treatment
No control group.
Below are reasons why this trial will not use a control group:

Primary Focus on Feasibility: The main goal of this trial is to determine if the study can be successfully conducted, not to compare outcomes between groups. Feasibility trials often serve as a precursor to larger, more definitive trials. Once feasibility is established, a more comprehensive trial can be designed with appropriate control groups.

Limited Resources: Recruiting a control group might require additional resources and time, which can be challenging in the autistic population, which has been considered a hard-to-recruit population in research.

Sample Size Constraints: In hard-to-recruit populations, achieving an adequate sample size for both treatment and control groups might not be possible.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339931 0
feasibility of the intervention.
Timepoint [1] 339931 0

Recruitment Rate: Tracked three months after the study commences using study records.
Retention Rate: Evaluated at weeks 7 and 13 of the intervention based on study records.
Adherence Rate: Measured using checklists and logbook data from participants' Intervention Manuals, assessed at weeks 7 and 13.
Monitoring of Adverse Events: Documented from week 0 to week 13 using fortnightly study records. In each fortnightly meeting with the dyad, the researcher will ask about adverse event in the last two weeks of the intervention.
Resource Utilization: Evaluated at week 13 based on study weekly records on expenses and resource usage.
Device Usage Adherence: Monitored via device reports, which will be updated daily to the cloud system throughout the intervention.
Primary outcome [2] 340148 0
acceptability of the intervention.
Timepoint [2] 340148 0
Adherence Rate: Determined from participants' weekly checklists and logbooks in their Intervention Manual at the end of the intervention.
Post-Intervention Survey: Conducted at week 13 using a standardised survey designed specifically for this study by the researchers.

Secondary outcome [1] 441953 0
A composite secondary outcome is the accumulation of Moderate and Vigorous Intensity Physical Activity
Timepoint [1] 441953 0
Measured by the Sens device at three seven-day periods: weeks 0 (pre-intervention week), week 7 (mid-intervention week), and week 13 (post-intervention week)
Secondary outcome [2] 441954 0
Accumulation of sedentary behaviours (e.g., lying down, sitting, time spent sedentary, sleep time will also be recorded).
Timepoint [2] 441954 0
Measured by the Sens device at three seven-day periods: weeks 0 (pre-intervention week), week 7 (mid-intervention week), and week 13 (post-intervention week)
Secondary outcome [3] 441956 0
A composite secondary outcome is the Self-monitored Physical activity and Sedentary behaviors levels
Timepoint [3] 441956 0
The participants must report their weekly total Active Zone Minutes and Stationary Hours using the activity log book provided in the Intervention Manual at the end of each week, from week 1 to week 12.
Secondary outcome [4] 441957 0
Self-Reported Physical Activity Motivation
Timepoint [4] 441957 0

Evaluated at at three seven-day periods: weeks 0 (pre-intervention week), week 7 (mid-intervention week), and week 13 (post-intervention week) .

Eligibility
Key inclusion criteria
Each participant pair will consist of an autistic adult (without intellectual and physical disabilities) and an adult partner of their choosing, drawn from their social network.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Having intellectual or physical disabilities that prevent the participants from reading, writing, understanding the materials, or participating in physical activities.
Having no access to smartphone, electronic devices, or internet for online communication via WhatsApp or other communication apps.

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
We will recruit at least 10 pairs of participants. Data collected via SENS will be exported using Sens Motion system, and analysed in SPSS. Feasibility measures will be reported using descriptive data. Provided this pilot will recruit the proposed number of participants, quantitative data will be analysed using linear mixed modelling to assess changes in the outcomes in the control and intervention groups. Fitbit data will be collected and gathered via cloud-based platform and analysed in SPSS. Acceptability data (scores) will be collected and analysed in SPSS.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/01/2025
Actual
Date of last participant enrolment
Anticipated
13/02/2025
Actual
Date of last data collection
Anticipated
19/05/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 317858 0
University
Name [1] 317858 0
Curtin University
Country [1] 317858 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 320191 0
None
Name [1] 320191 0
Address [1] 320191 0
Country [1] 320191 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316538 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 316538 0
Ethics committee country [1] 316538 0
Australia
Date submitted for ethics approval [1] 316538 0
10/10/2024
Approval date [1] 316538 0
Ethics approval number [1] 316538 0

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

Contacts
Principal investigator
Name 138202 0
A/Prof Joanne McVeigh
Address 138202 0
Curtin University, Kent St, Bentley WA 6102
Country 138202 0
Australia
Phone 138202 0
+61892667247
Fax 138202 0
Email 138202 0
joanne.mcveigh@curtin.edu.au
Contact person for public queries
Name 138203 0
Vu Ngoc Duong
Address 138203 0
Curtin University, Kent St, Bentley WA 6102
Country 138203 0
Australia
Phone 138203 0
+61 402745678
Fax 138203 0
Email 138203 0
Vu.duong@curtin.edu.au
Contact person for scientific queries
Name 138204 0
Vu Ngoc Duong
Address 138204 0
Curtin University, Kent St, Bentley WA 6102
Country 138204 0
Australia
Phone 138204 0
+61 402745678
Fax 138204 0
Email 138204 0
Vu.duong@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Deidentified participants' data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access is subjected to approvals by Principle Investigation (Joanne McVeigh, joanne.mcveigh@curtin.edu.au) and contact of the project (Vu Ngoc Duong, Vu.duong@curtin.edu.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24350Ethical approval  vu.duong@curtin.edu.au Ethics approval letter will be uploaded upon gaini... [More Details]
24375Informed consent form  vu.duong@curtin.edu.au 388786-(Uploaded-28-11-2024-18-19-44)-Autistic participants' information sheet and consent.docx
24376Informed consent form  vu.duong@curtin.edu.au 388786-(Uploaded-28-11-2024-18-19-59)-Partner's information sheet and consent.docx
24377Study protocol  vu.duong@curtin.edu.au 388786-(Uploaded-28-11-2024-18-20-17)-Intervention manual.docx



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.