Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000165583
Ethics application status
Approved
Date submitted
31/10/2023
Date registered
21/02/2024
Date last updated
21/02/2024
Date data sharing statement initially provided
21/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A 4-Week Digital Physical Activity Intervention Based Program to Investigate its Impact on Physical Activity
Scientific title
A Digital Interactive Program Delivered by a Social Robot to Investigate its Impact on Physical Activity and Confidence in Performing Physical Activity in Adults
Secondary ID [1] 310555 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity 331385 0
Condition category
Condition code
Public Health 328134 328134 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is designed to investigate the impact and efficacy of the new digital method (i.e. a commercially available social humanoid robot with a tablet interface) to deliver a physical activity intervention-based program over a 4-week period. It is intended that this trial will explore how a social humanoid robot can help people set physical activity goals and encourage them to achieve them. The intervention does not prescribe specific exercises nor a minimum frequency and/or duration of exercise. It rather focuses on encouraging and helping people to achiever a physical activity goal of their choosing.

This will be done through interactive sessions that involve participants interacting with the social robot and completing physical activity logs and surveys/questionnaires to evaluate metrics such as confidence and level of physical activity. The interactive sessions will not be supervised. However, they will take place in a controlled environment and a member of the research team will be nearby during the session to assist participants if needed. Participants will not interact with the Pepper robot outside of the scheduled, interactive sessions.

Participants will complete two 60-minute in-person sessions conducted at Monash University. This session will include a Pepper robot leading the session which involves content and training to deliver a robot-adapted version of a physical activity and goal setting (or evaluation) based program. The first session will occur at the beginning of the program, Week O, and the content delivered by the Pepper robot will focus on goal setting. The second session will be conducted in Week 2 and focus on evaluating how the participant is tracking. Each participant will complete the sessions on their own, working and interacting with the robot to complete the content. At the end of the second session, participants will be invited to complete a 10-minute interview with a research team member about their experience with the robot program.

Participants will receive two weekly emails after the first session until the end of the 4-week program that involves completing additional program content that is expected to take 5 - 10 minutes to complete. The first email will be a general reminder to ensure participants are logging their physical activity on the website portal. The second email will contain the same reminder as the first plus a reminder to complete the surveys based on how they are feeling. Participants will be asked to complete 3 x 20-minute online questionnaires at week zero, two and four weeks.
Intervention code [1] 326950 0
Behaviour
Intervention code [2] 326951 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336437 0
The effect of a social robot delivery-based program on physical activity in adults over a 4-week period (International Physical Activity Questionnaire).
Timepoint [1] 336437 0
Baseline - prior to commencement of program, Week 2 - post commencement of the program and prior to 2nd session with the social robot, Week 4 (primary timepoint) - post commencement of the program.
Secondary outcome [1] 428403 0
Effect of social robot delivery-based program on confidence in performing physical activity over a 4-week period (Exercise efficacy scale).
Timepoint [1] 428403 0
Baseline - prior to commencement of program, Week 2 - post commencement of the program and prior to 2nd session with the social robot, Week 4 - post commencement of the program.
Secondary outcome [2] 428404 0
Impact of of social robot delivery-based program on motivation to perform physical activity (The Motivational Thought Frequency Scales)
Timepoint [2] 428404 0
Baseline - prior to commencement of program, Week 2 - post commencement of the program and prior to 2nd session with the social robot, Week 4 - post commencement of the program.

Eligibility
Key inclusion criteria
At least 18 years of age or older.
Perform on average less than 60 minutes of physical activity each week.
No medical conditions that would preclude you from exercising,
Speak, read and understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are not at least 18 years of age or older and able to provide consent

Study design
Purpose of the study
Treatment
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
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/03/2024
Actual
Date of last participant enrolment
Anticipated
12/04/2025
Actual
Date of last data collection
Anticipated
10/05/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314757 0
University
Name [1] 314757 0
Monash University
Country [1] 314757 0
Australia
Primary sponsor type
University
Name
Monash University
Address
18 Alliance Lane, Clayton Campus, VIC 3800, Australia
Country
Australia
Secondary sponsor category [1] 316740 0
None
Name [1] 316740 0
Address [1] 316740 0
Country [1] 316740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313765 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 313765 0
24 Sports Walk, Clayton Campus, Wellington Rd, Clayton VIC 3800, Australia
Ethics committee country [1] 313765 0
Australia
Date submitted for ethics approval [1] 313765 0
21/08/2023
Approval date [1] 313765 0
14/09/2023
Ethics approval number [1] 313765 0
39777

Summary
Brief summary
This project is designed to investigate the impact of a social humanoid robot to deliver a low-intensity program about improving physical activity. It is intended that this trial will focus on how a robot can help people to increase their physical activity. This will include finding how the relationship the participant has with the robot will act to create variable outcomes in physical activity.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129294 0
Dr Pamela Carreno-Medrano
Address 129294 0
Monash University, 18 Alliance Lane, Clayton Campus, VIC 3800, Australia
Country 129294 0
Australia
Phone 129294 0
+61399055562
Fax 129294 0
Email 129294 0
pamela.carreno@monash.edu
Contact person for public queries
Name 129295 0
Dr Pamela Carreno-Medrano
Address 129295 0
Monash University, 18 Alliance Lane, Clayton Campus, VIC 3800, Australia
Country 129295 0
Australia
Phone 129295 0
+61399055562
Fax 129295 0
Email 129295 0
pamela.carreno@monash.edu
Contact person for scientific queries
Name 129296 0
Dr Pamela Carreno-Medrano
Address 129296 0
Monash University, 18 Alliance Lane, Clayton Campus, VIC 3800, Australia
Country 129296 0
Australia
Phone 129296 0
+61399055562
Fax 129296 0
Email 129296 0
pamela.carreno@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.