Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000492954p
Ethics application status
Submitted, not yet approved
Date submitted
10/04/2020
Date registered
20/04/2020
Date last updated
20/04/2020
Date data sharing statement initially provided
20/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Facebook delivered physical activity focused group lifestyle intervention for older adults during the COVID-19 pandemic
Scientific title
Feasibility of a Facebook delivered physical activity focused group lifestyle intervention for older adults during the COVID-19 pandemic
Secondary ID [1] 300981 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health
 317015 0
Physical inactivity 317016 0
Condition category
Condition code
Physical Medicine / Rehabilitation 315182 315182 0 0
Other physical medicine / rehabilitation
Mental Health 315183 315183 0 0
Depression
Public Health 315259 315259 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will recruit older adults (aged 60 years and older) during the COVID-19 pandemic to a 6-week, group based physical activity promotion intervention delivered online through a private Facebook group. The group will allow members to receive information and contribute to weekly conversations on pre-specified topics related to physical activity eg. sedentary behaviour, goal setting, benefits of physical activity and support. Different topics will be covered each week with 2-3 Facebook posts on the topic each week. The content of each topic is designed specifically for this study but will also make use of existing videos, pictures and information sources. An exercise physiologists and dietitian will deliver the program. The purpose of the Facebook group is to facilitate social support and provide participants with a platform to exchange personal experiences including barriers and facilitators to commencing and maintaining a physical activity program. While discussion topics will be pre-determined, discussion will change weekly based on the participants posts for example someone may ask for examples of workouts or different ways overcome barriers. Participants will also be able to join a group video call via zoom two times per week. These calls will last for 20-30mins. The facilitator will lead the call and provide education on the topic for the week. This will also give the facilitator the chance to check in on participants and allow them to ask questions. The intervention itself will go for 6 weeks however there is the option for participants to remain in the Facebook group and continue to use it for support without the input from the facilitators. All 20 participants will be included in the one Facebook group and encouraged to check the Facebook weekly. The page will be monitored by a member of the research team at least 5 times per week. Contribution to the page in regards to posting/liking material is optional.
Intervention code [1] 317304 0
Treatment: Other
Intervention code [2] 317305 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323438 0
Feasibility. Measured by:
1. Participant retention (in program and completion of questionnaires).
2. Usage of the Facebook group (manual calculation of the sum of comments & likes)
3. Feasibility and acceptability questionnaire (modified version of Naslund et al's (2016) Feasibility and Acceptability questionnaire)
Timepoint [1] 323438 0
Post intervention (week 6)
Primary outcome [2] 323439 0
SIDAS- Suicidal Ideation Attributes Scale
Timepoint [2] 323439 0
Post intervention (week 6)
Secondary outcome [1] 381948 0
AQoL-6D- quality of life
Timepoint [1] 381948 0
Post intervention (week 6)
Secondary outcome [2] 381949 0
UCLA loneliness scale
Timepoint [2] 381949 0
Post intervention (week 6)
Secondary outcome [3] 381950 0
K10- Kessler 10 (psychological distress)
Timepoint [3] 381950 0
Post intervention (week 6)
Secondary outcome [4] 381951 0
SIMPAQ- The Simple Physical Activity Questionnaire
Timepoint [4] 381951 0
Post intervention (week 6)
Secondary outcome [5] 381952 0
Function component of the late life function and disability instrument
Timepoint [5] 381952 0
Post intervention (week 6)

Eligibility
Key inclusion criteria
1) Adults aged 60 years and over
2) Living alone
3) Cleared to participant in an exercise program (absence of any American College of Sports Medicine absolute contraindications to exercise)
4) Currently engaging in <150 mins of moderate to vigorous physical activity
5 Able to walk around inside the house without the use of a walking aid
5) English speaking
6) Access to the internet and an active Facebook account or willing to create one
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Although we will not specifically target older adults with a diagnosed mental disorder, by nature of the target population, it is expected that a high proportion of the participants will be experiencing poor mental health. Severely depressed individuals or those experiencing frequent suicidal ideation at the outset will be excluded from the study and directed towards appropriate services in their community. Participants will be screened prior to commencement of the study and those who receive a score in the K-10 questionnaire of >30 will be contacted by the research team. If these participants are not receiving treatment the research team will recommended they do and then excluded them from the study. Likewise, those whose medications have changed in the past 4 weeks will also be excluded.

Participants will also be screened with the physical activity vital sign and the ESSA pre-screening tool. Those who exceed 150mins of moderate-vigorous PA will be excluded and those who answer yes to any of the 7 ESSA pre-screening questions must get clearance to exercise from a general practitioner.

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
Who is / are masked / blinded?



Intervention assignment
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
1/05/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305429 0
University
Name [1] 305429 0
University of New South Wales
Country [1] 305429 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 305819 0
None
Name [1] 305819 0
NA
Address [1] 305819 0
NA
Country [1] 305819 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305748 0
University of New South Wales Human Research Ethics Application Form
Ethics committee address [1] 305748 0
Ethics committee country [1] 305748 0
Australia
Date submitted for ethics approval [1] 305748 0
01/04/2020
Approval date [1] 305748 0
Ethics approval number [1] 305748 0

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

Contacts
Principal investigator
Name 101454 0
A/Prof Simon Rosenbaum
Address 101454 0
UNSW Sydney, NSW 2052
Australia
Country 101454 0
Australia
Phone 101454 0
+61 2 9385 7536
Fax 101454 0
Email 101454 0
[email protected]
Contact person for public queries
Name 101455 0
Grace McKeon
Address 101455 0
UNSW Sydney, NSW 2052
Australia
Country 101455 0
Australia
Phone 101455 0
+61 434041357
Fax 101455 0
Email 101455 0
[email protected]
Contact person for scientific queries
Name 101456 0
Grace McKeon
Address 101456 0
UNSW Sydney, NSW 2052
Australia
Country 101456 0
Australia
Phone 101456 0
+61 434041357
Fax 101456 0
Email 101456 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
No additional documents have been identified.