Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001124921
Ethics application status
Approved
Date submitted
20/08/2020
Date registered
30/10/2020
Date last updated
30/10/2020
Date data sharing statement initially provided
30/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Facebook delivered physical activity focused group lifestyle intervention for the families of children with genetic epilepsy
Scientific title
Feasibility of a Facebook delivered physical activity focused group lifestyle intervention for the families of children with genetic epilepsy
Secondary ID [1] 302090 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 318703 0
Post traumatic stress disorder 318704 0
Physical inactivity 318705 0
Genetic epilepsy 319102 0
Condition category
Condition code
Mental Health 316716 316716 0 0
Depression
Neurological 317057 317057 0 0
Epilepsy
Public Health 317058 317058 0 0
Health promotion/education
Mental Health 317059 317059 0 0
Other mental health disorders
Human Genetics and Inherited Disorders 317060 317060 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physical activity intervention will be 4-weeks in duration and be delivered online through a private Facebook group. The group will be titled ‘Movement for the parents and families of children with genetic epilepsy.’ The research team will provide education on pre-determined weekly topics and facilitate discussion boards e.g. goal setting, barriers and sedentary behaviour. The topics will include: 1. Introductions/barriers to activity, 2. Goal setting and ways to address barriers, 3. Resistance/aerobic guidelines and resources, 4. Review of progress, plan going forward. These posts will all occur from the study generated account.


Participants will be provided with a Fitbit prior to the intervention and asked to wear it daily. This is an activity tracker worn on the wrist that measures data such as steps and active minutes and syncs to a personal Fitbit dashboard where participants can set personal goals and track progress. The research team will be using Fitbit’s health solutions platform where they will be able to log in and access data from the participants activity trackers. The Fitbit will be encouraged to be worn during waking hours, but can also be worn overnight if participants choose.The health solutions platform is typically used for workplaces however we have will use a private group for our study. After the 4-week trial participants will have the choice to remain in the Facebook group and continue to use it as a form of social support for exercise without the input from facilitators. There is no minimum requirement of access to the Facebook group, however participants will be encouraged to check it regularly. Adherence will be measured by views per post on the Facebook group.


Intervention code [1] 318388 0
Lifestyle
Intervention code [2] 318624 0
Prevention
Intervention code [3] 318625 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324854 0
Feasibility
1)Usage of the Facebook group (manual calculation of the sum of post views, likes, and comments)
Timepoint [1] 324854 0
Assessed weekly throughout the 4 week intervention.
Primary outcome [2] 324855 0
2)Fitbit compliance (% of days worn). This will be assessed from data from the Fitbit platform.
Timepoint [2] 324855 0
Weekly throughout the 4 week intervention.
Primary outcome [3] 325154 0
3)Participant retention. This will be assessed in 2 ways- firstly the % of participants who remain in the Facebook group until the end of week 4 and secondly, the % of participants who complete the post program questionnaires.
Timepoint [3] 325154 0
4 weeks post intervention commencement
Secondary outcome [1] 385954 0
PCL-5: Self-reported symptoms of PTSD

Timepoint [1] 385954 0
1)Within 1 week pre-intervention commencement
2)The completion of intervention at the end of week 4
3)Follow-up at 4 weeks post-intervention completion
Secondary outcome [2] 385955 0
SIDAS: The Suicidal Ideation Attributes Scale
Timepoint [2] 385955 0
1)Within 1 week pre-intervention commencement
2)The completion of intervention at the end of week 4
3)Follow-up at 4 weeks post-intervention completion
Secondary outcome [3] 385956 0
K10: Kessler 10 (psychological distress)
Timepoint [3] 385956 0
1)Within 1 week pre-intervention commencement
2)The completion of intervention at the end of week 4
3)Follow-up at 4 weeks post-intervention completion
Secondary outcome [4] 385991 0
SIMPAQ: The Simple Physical Activity Questionnaire
Timepoint [4] 385991 0
1)Within 1 week pre-intervention commencement
2)The completion of intervention at the end of week 4
3)Follow-up at 4 weeks post-intervention completion
Secondary outcome [5] 385992 0
Naslund's feasibility questionnaire
Timepoint [5] 385992 0
)The completion of intervention at the end of week 4
Secondary outcome [6] 387025 0
AQoL-6D: quality of life
Timepoint [6] 387025 0
1)Within 1 week pre-intervention commencement
2)The completion of intervention at the end of week 4
3)Follow-up at 4 weeks post-intervention completion

Eligibility
Key inclusion criteria
This research study will recruit a convenience sample of i) parents/primary carers of children with genetic epilepsy, ii) aged 18-65 years, iii) currently physically inactive defined as engaging in less than 150 mins per week of moderate-vigorous physical activity per week, iv) cleared to participate in an exercise program (absence of any American College of Sports Medicine (ACSM) absolute contraindications to exercise participation). Participants must also speak English, have internet access and an active Facebook account or be willing to create one.

The parents/primary carer must also nominate their support partner/carer who may be any person with a close personal relationship to them e.g. partner, family member, carer or friend who have at least weekly in-person contact with each other. This person must also be between 18-65 years and be medically absent from any ACSM absolute contraindications to exercise.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be screened prior to commencement of the study and those who receive a score in the K10 questionnaire of >30 will be sent the mental health service utilization questionnaire and asked whether any mental health medication has changed in the past 4 weeks. If these participants are not receiving treatment they will be called by the research team who will recommended they do and then exclude them from the study. Likewise, those whose medications have changed in the past 4 weeks will also be contacted and 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
10/08/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 306510 0
University
Name [1] 306510 0
University of New South Wales
Country [1] 306510 0
Australia
Primary sponsor type
University
Name
UNSW
Address
UNSW Sydney, NSW 2052
Australia
Country
Australia
Secondary sponsor category [1] 307045 0
Hospital
Name [1] 307045 0
Sydney Children's Hospital
Address [1] 307045 0
Sydney Children's Hospital
High Street, Randwick NSW 2031
Country [1] 307045 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306712 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 306712 0
Ethics committee country [1] 306712 0
Australia
Date submitted for ethics approval [1] 306712 0
Approval date [1] 306712 0
29/05/2020
Ethics approval number [1] 306712 0

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

Contacts
Principal investigator
Name 104762 0
A/Prof Simon Rosenbaum
Address 104762 0
UNSW Sydney, NSW 2052
Australia
Country 104762 0
Australia
Phone 104762 0
+61 2 93828511
Fax 104762 0
Email 104762 0
[email protected]
Contact person for public queries
Name 104763 0
Grace McKeon
Address 104763 0
UNSW Sydney, NSW 2052
Australia
Country 104763 0
Australia
Phone 104763 0
+61 434041357
Fax 104763 0
Email 104763 0
[email protected]
Contact person for scientific queries
Name 104764 0
Grace McKeon
Address 104764 0
UNSW Sydney, NSW 2052
Australia
Country 104764 0
Australia
Phone 104764 0
+61 434041357
Fax 104764 0
Email 104764 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
Participants could be identifiable since they are all parents of a child with rare genetic epilepsy.


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.