Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001322820
Ethics application status
Approved
Date submitted
18/08/2021
Date registered
29/09/2021
Date last updated
24/02/2023
Date data sharing statement initially provided
29/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A mental health-informed, online health promotion and balance exercise program for adults aged 60+ years: the MovingTogether trial
Scientific title
A mental health-informed, online health promotion and balance exercise program for adults aged 60+ years: the MovingTogether randomised controlled trial
Secondary ID [1] 305072 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
This trial is a follow-up study to ACTRN12620000492954

Health condition
Health condition(s) or problem(s) studied:
Mental health 323288 0
Physical inactivity 323289 0
Condition category
Condition code
Physical Medicine / Rehabilitation 320855 320855 0 0
Other physical medicine / rehabilitation
Mental Health 320856 320856 0 0
Depression
Public Health 320857 320857 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MovingTogether health promotion program

Participants will join a private Facebook group, monitored by the facilitators at least once every weekday over the 10-week period. Targeted education and resources will be provided to participants through the Facebook group throughout the program and facilitators will encourage discussion between all members of the group, regarding a variety of lifestyle topics. Topics will include behaviour change, overcoming barriers, reducing sedentary behaviour, increasing physical activity, increasing structured exercise, balance training and healthy eating. Education on a single topic will be the focus of a single week (two weeks in the case of the health eating topic) and new material will be released every week. These educational material have an designed specifically for this study by allied health professionals (Accredited Exercise Physiologists and a Dietician). These materials include a range of written resources and videos and will be conveyed using the private discussion forum on Facebook.

Private Facebook groups will be used in the intervention for facilitators to share educational posts and encourage discussion between participants about shared experience. The main aim of the group is to foster social connection and support between participants. The group will include 40 individuals in order to promote social connection and increase the potential for individualised time with allied health facilitators. Some participants may be satisfied simply reading posts and not responding. There is no minimum engagement or time that participants are required to spend in the group. There will be recommendations such as spending 2hrs per week training balance, however participants can spend more or less time on activities than is recommended.

Additionally, participants can choose to join an optional weekly 20-30min tele-health group call via Zoom, led by an ESSA accredited exercise physiologist (AEP) and a dietician when nutrition is the focus. The purpose of these calls is to promote social connection between participants and to follow up and create discussion about the provided educational materials. As these calls are optional, attendance will not be noted.

Adherence to exercise is not an outcome of the study. An informal approach will be taken to encourage adherence, where researchers will ask individuals during telehealth calls and private messaging to reflect exercise engagement through goal setting and habit formation education. They will also be encouraged to share their reflections with the group if they feel comfortable doing so. Changes in physical activity levels more broadly, as opposed to adherence to a specific exercise program will be assessed pre- and post-intervention to allow researchers to understand the effect of the program on influencing physical activity participation.

Participants will also have access to the StandingTall eHealth website, providing home-based exercise to improve balance and reduce fall risk. StandingTall is a pre-existing website, however is yet to be release for public use. Researchers have evaluated StandingTall through a randomised controlled trial and found it to reduce fall risk over a 24 month period of use. Individuals will be provided with access to the program and a manual on setting up and using the application. All participants will be encouraged to gradually aim to complete 2hrs of balance training using the app per week and website analytics will track adherence data, however use of the app is optional. Exercises include side steps, step ups and single leg balance. At the conclusion of the 10-week program, StandingTall will continue to be accessible to participants if they wish. Total access will last for 24 months, as this is the length of time that has be found to be beneficial for participants. The Facebook group will also still remain accessible. Both the group and StandingTall will continue without input from facilitators. However, participants are encouraged to maintain social connections independently.
Intervention code [1] 321468 0
Prevention
Intervention code [2] 321469 0
Lifestyle
Comparator / control treatment
The intervention group will be compared to a waitlist control group who will not receive access to the health promotion program until after assessment.

The waitlist control group will be offered the intervention after the 1-month follow up period.
Control group
Active

Outcomes
Primary outcome [1] 328657 0
Psychological distress (K10: Kessler 10 Scale)
Timepoint [1] 328657 0
Post-intervention (week 11)
Secondary outcome [1] 399843 0
Physical activity levels (IPEQ: Incidental and Planned Exercise Questionnaire)
Timepoint [1] 399843 0
Post-intervention (week 11)
Secondary outcome [2] 399844 0
Physical functioning (functional component of the Late Life Function and Disability Instrument)
Timepoint [2] 399844 0
Post-intervention (week 11)
Secondary outcome [3] 399845 0
Cognitive flexibility (Trail-making test)
Timepoint [3] 399845 0
Post-intervention (week 11)
Secondary outcome [4] 399846 0
Social capital (Social Capital Questionnaire)
Timepoint [4] 399846 0
Post-intervention (week 11)
Secondary outcome [5] 399848 0
Loneliness (UCLA Loneliness Scale)
Timepoint [5] 399848 0
Post-intervention (week 11)
Secondary outcome [6] 399849 0
Quality of Life (European Quality of Life Five Dimensions: EQ-5D)
Timepoint [6] 399849 0
Post-intervention (week 11)
Secondary outcome [7] 400737 0
Emotional intelligence (Trait Emotional Intelligence Questionnaire)
Timepoint [7] 400737 0
Post-intervention (week 11)
Secondary outcome [8] 400738 0
Memory task (n-Back task)
Timepoint [8] 400738 0
Post-intervention (week 11)
Secondary outcome [9] 400739 0
Decision-making (Iowa gambling task)
Timepoint [9] 400739 0
Post-intervention (week 11)
Secondary outcome [10] 407787 0
Concern about falling (Icon-FES: Iconographical Falls Efficacy Scale)
Timepoint [10] 407787 0
Post-intervention (week 11)
Secondary outcome [11] 407788 0
Enjoyment (PACES: Physical Activity Enjoyment Scale)
Timepoint [11] 407788 0
Post-intervention (week 11)

Eligibility
Key inclusion criteria
i) 60+ years
ii) Proficient in written and spoken English
iii) Living in the community, in Australia
iv) Mobilise indoors without the use of a walking aid
v) Have internet, Facebook and either computer, laptop or iPad/tablet access
vi) Self-reported to be currently participating in less than 150 min of moderate to vigorous intensity physical activity per week
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
i) Have high levels of psychological distress (score of >30 on the K10) and are not seeking professional mental health treatment or have had a change in psychotropic medications in the last 4 weeks. These individuals are excluded because this program is not intended to be a mental health treatment program.
ii) High risk of suicidal behaviour (score of >21 on the SIDAS) unless deemed eligible to participate by a psychologist. These individuals are excluded because this program is not intended to be a mental health treatment.
iii) Absolute contraindications to exercise as assessed by accredited exercise physiologists using the American College of Sports Medicine (ACSM) guidelines. Exclusion of individuals meeting this criterion is due to safety. We could not allow them to participate in this physical activity program if exercise may pose a safety risk to them. Those with relative contraindications will be excluded if they are unable to obtain a clearance to exercise letter from their doctor.
v) Currently participating in a falls prevention program
vi) Severe cognitive impairment (score of >8) on the Short Portable Mental Status Questionnaire (SPMSQ)

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis using IBM SPSS 25 will evaluate whether there are any significant changes between baseline and post-intervention on psychological distress and secondary outcomes, as well as between baseline and results at the follow up point. Linear mixed models will be applied for each outcome measure, conducted using the MIXED procedure (taking into account data at all time points). Time will be considered a categorical variable for each outcome. Effect sizes (Cohen’s d, and the 95% confidence intervals) will be calculated to determine the size of the within-group change between before and after treatment and between before treatment and 1 month post-intervention. Marginal means drawn from the mixed models will be used.

Analyses will use all available data as per an intention-to-treat approach. The between-group difference at follow-up [mean difference (MD) and 95% confidence interval] will be calculated for all outcome measures using linear regression models with group as the independent variable, follow-up score on the outcome measures as the dependent variable, baseline score on the outcome measure as a covariate, and statistical significance set at P < 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/05/2022
Actual
1/02/2022
Date of last participant enrolment
Anticipated
1/06/2022
Actual
1/06/2022
Date of last data collection
Anticipated
1/09/2022
Actual
3/10/2022
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309470 0
University
Name [1] 309470 0
UNSW
Country [1] 309470 0
Australia
Primary sponsor type
University
Name
UNSW
Address
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 310440 0
None
Name [1] 310440 0
N/A
Address [1] 310440 0
N/A
Country [1] 310440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309259 0
UNSW HREC Committee B
Ethics committee address [1] 309259 0
Ethics committee country [1] 309259 0
Australia
Date submitted for ethics approval [1] 309259 0
09/08/2021
Approval date [1] 309259 0
17/09/2021
Ethics approval number [1] 309259 0
HC210654

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

Contacts
Principal investigator
Name 113526 0
A/Prof Simon Rosenbaum
Address 113526 0
UNSW Sydney, NSW 2052
Country 113526 0
Australia
Phone 113526 0
+61 293857536
Fax 113526 0
Email 113526 0
[email protected]
Contact person for public queries
Name 113527 0
Chiara Mastrogiovanni
Address 113527 0
UNSW Sydney, NSW 2052
Country 113527 0
Australia
Phone 113527 0
+61 451652163
Fax 113527 0
Email 113527 0
[email protected]
Contact person for scientific queries
Name 113528 0
Chiara Mastrogiovanni
Address 113528 0
UNSW Sydney, NSW 2052
Country 113528 0
Australia
Phone 113528 0
+61 451652163
Fax 113528 0
Email 113528 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
Individual participant data may be easily identifiable by those within the same intervention group based on their physical activity levels, occupation, age etc.


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
EmbaseA mental health-informed, online health promotion programme targeting physical activity and healthy eating for adults aged 60+ years: study protocol for the MovingTogether randomised controlled trial.2022https://dx.doi.org/10.1186/s13063-022-06978-3
N.B. These documents automatically identified may not have been verified by the study sponsor.