Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000315718p
Ethics application status
Submitted, not yet approved
Date submitted
11/01/2022
Date registered
21/02/2022
Date last updated
21/02/2022
Date data sharing statement initially provided
21/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of daily online health behaviour tracking to supplement Exercise Physiologist led health behaviour modification across a range of practise contexts.
Scientific title
An evaluation of scores recorded on daily online health behaviour tracking to supplement Exercise Physiologist led health behaviour modification across a range of practise contexts.
Secondary ID [1] 305894 0
Nil
Universal Trial Number (UTN)
U1111-1272-6047
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic disease 324715 0
Cardiovascular disease 325112 0
musculoskeletal injury 325113 0
Cancer 325114 0
Neurological disease 325115 0
Mental illness 325116 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322163 322163 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project is a 12-month, two-arm, randomised control trial with participants randomised into either the Food, Exercise, Stress and Sleep (FESS) intervention group or a control group.

The FESS intervention group will have access to the online FESS Questionnaire for 12 months, which is completed daily (2-3 minutes in duration) in participants' own time.

Once the baseline testing has been completed, researchers will confirm when participants are ready to begin the intervention and provide access to the FESS dashboard. The FESS group will be prompted daily to complete the FESS questionnaire via email, seven days a week, for 12 weeks.

In short, the FESS survey is comprised of 8 questions regarding food/diet, 4 questions around exercise, 6 questions around stress, and 5 questions around their sleep. A FESS score will be given after the survey is complete out of 100. Participants will also receive ongoing researcher-driven prompts by telephone or text (personal choice).

During the first three months of the intervention, participants in the FESS group will have adherence support from the research team. The exercise physiologist’s at each site will be encouraged to discuss the FESS scores in their consultations with participants. Scores can be used to highlight where a participant is improving (for example, increasing vegetable intake) or areas they may need to improve. EP's can then provide strategies (motivational interviewing, problem-solving and goal setting) to maintain or improve FESS scores. However, this is optional as the EPs may choose not to engage with FESS scores and process to supplement their behaviour change counselling.

Furthermore, accelerometers and questionnaires will be used in a sub-group of participants to validate the FESS survey against commonly accepted criterion measures. The total score of the food component in the FESS questionnaire will be validated against the Automated Self-Administered 24-Hour Dietary Assessment tool (ASA24). The total score of the exercise component in the FESS questionnaire will be validated against accelerometry (moderate-to-vigorous physical activity levels) and the International Physical Activity Questionnaire – Short Form (IPAQ-SF). The total score of the sleep component in the FESS questionnaire will be validated against the Pittsburgh Sleep Quality Index (PSQI). Finally, the total score of the sleep component in the FESS questionnaire will be validated against the Perceived Stress Scale (PSS-10).

All participants will be asked if they wish to opt-in to the subgroups. Participants will have an option of completing the exercise and sleep validation measures and/or the food and stress validation measures. There will be no limit on participation. The validation subgroup will undertake testing within the first three weeks of the intervention at a time most suitable to the participants.
Intervention code [1] 322579 0
Behaviour
Comparator / control treatment
The control group will continue their usual treatment plan prescribed and supervised by their exercise physiologists. Over the 12 weeks, they will be provided with four separate pieces of reliable and evidence-based information publicly available on healthy behaviours via email. It is expected that participants will spend approximately 15 minutes engaging in the email informationAfter completion of follow up questionnaire, they will receive access to the FESS questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 330085 0
Total FESS score
Timepoint [1] 330085 0
Week 0 (pre-commencement of intervention), 12 (primary timepoint), and 52 (follow up measure) post-commencement of intervention
Secondary outcome [1] 404836 0
The total score of the food component in the FESS questionnaire
Timepoint [1] 404836 0
Week 0 (pre-commencement of intervention), week 12, and 52 (follow up measure) post-commencement of intervention
Secondary outcome [2] 404838 0
The total score of the exercise component in the FESS questionnaire
Timepoint [2] 404838 0
Week 0 (pre-commencement of intervention), 12, and 52 (follow up measure) post-commencement of intervention
Secondary outcome [3] 404841 0
The total score of the sleep component in the FESS questionnaire
Timepoint [3] 404841 0
Week 0 (pre-commencement of intervention), 12, and 52 (follow up measure) post-commencement of intervention
Secondary outcome [4] 404843 0
The total score of the stress component in the FESS questionnaire
Timepoint [4] 404843 0
Week 0 (pre-commencement of intervention), 12, and 52 (follow up measure) post-commencement of intervention
Secondary outcome [5] 404845 0
Frequency of FESS Questionnaire completion (assessed via website analytics)
Timepoint [5] 404845 0
Week 12 and 52 (follow up measure) post-commencement of intervention

Eligibility
Key inclusion criteria
• Be newly-referred or current patients within the exercise physiology service who are likely to have to continue with the exercise physiology service for at least four more weeks
• Able to read and write in English. The restriction on language is necessary because English is the only language spoken by investigators, and there is a lack of resources for a translator.
• Provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• No access to a device with the Internet. The questionnaire is provided online-only as dissemination of results to participants and exercise physiologists are done through computer-based algorithms.
• Insufficient IT competency to open and close web browser windows (via smartphone or tablet/computer).
• Diagnosed cognitive impairment or demonstrated inability to understand information from and project instructions

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central block randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratification allocation will be used (Groups will be randomised using a block randomised technique to balance age, sex and the number of new clients and continuing clients)
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
Study data will be analysed using SPSS version 26 (IBM, Chicago, IL, USA). Descriptive statistics will be calculated for all study variables. Friedman’s test will be used to conduct between-group comparisons across time points.

Spearman’s Rho will be used to assess the correlation between criterion measures and the relative FESS scores Validity coefficients closer to 1 indicated a closer relationship between the FESS score and the estimated “true” score (29). For this analysis, a validity coefficient will be interpreted as follows: < 0.20: Slight agreement, 0.21– 0.40: Fair agreement, 0.41–0.60: Moderate agreement, 0.61–0.80: Substantial agreement, 0.81–0.99: Almost perfect agreement (29).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
31/07/2022
Actual
Date of last data collection
Anticipated
31/08/2023
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 21447 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 36349 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 310242 0
University
Name [1] 310242 0
The University of South Australia
Country [1] 310242 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
iNform Health and Fitness
Address
9 Kensington Rd,
Norwood SA 5067
Country
Australia
Secondary sponsor category [1] 311688 0
None
Name [1] 311688 0
Address [1] 311688 0
Country [1] 311688 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309921 0
SA Health (CALHN) Ethics Committee
Ethics committee address [1] 309921 0
Royal Adelaide Hospital
Port Road
Adelaide SA 5000
Ethics committee country [1] 309921 0
Australia
Date submitted for ethics approval [1] 309921 0
24/01/2022
Approval date [1] 309921 0
Ethics approval number [1] 309921 0

Summary
Brief summary
This project aims to undertake a multi-centre randomised controlled trial to evaluate the addition of the web-based health behaviour tool (FESS) to existing exercise physiology and exercise science services with the intention of improving health behaviours. The project is a 12-month, two-arm, randomised control trial with participants randomised into either the FESS intervention group or a control group. It is hypothesised that the FESS group will improve their health behaviours (as measured by the FESS questionnaire) in comparison to the control group.

The FESS intervention group will have access to the online FESS Questionnaire for 12 months, which is completed daily (2-3 minutes in duration) in participants' own time. During the first three months of the intervention, participants in the FESS group will have adherence support from the research team.

The control group will be simply directed to web-based government health behaviour information. The research team will then independently complete the eligibility screening and explain the study to participants at each location.

Mixed evaluation methods will assess outcome measures at baseline, 3-month, 6-month and 12-month in both groups. FESS questionnaire adherence to the questionnaire will be evaluated in the FESS intervention group. Furthermore, accelerometers and questionnaires will be used in a sub-group of participants to validate the FESS survey against commonly accepted criterion measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115842 0
A/Prof Kade Davison
Address 115842 0
University of South Australia
Corner of North Terrace and, Frome Rd,
Adelaide SA 5001
Country 115842 0
Australia
Phone 115842 0
+61 8 830 21152
Fax 115842 0
Email 115842 0
Kade.Davison@unisa.edu.au
Contact person for public queries
Name 115843 0
Ms Holly Evans
Address 115843 0
iNform Health
9 Kensington Road
Norwood, SA, 5067
Country 115843 0
Australia
Phone 115843 0
+61 0421765004
Fax 115843 0
Email 115843 0
holly@informhealth.com
Contact person for scientific queries
Name 115844 0
Ms Holly Evans
Address 115844 0
iNform Health
9 Kensington Road
Norwood, SA, 5067
Country 115844 0
Australia
Phone 115844 0
+61 0421765004
Fax 115844 0
Email 115844 0
holly@informhealth.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
FESS Questionnaire totals (but not individual scores), Automated Self-Administered 24-Hour Dietary Assessment tool (ASA24), accelerometry (moderate-to-vigorous physical activity levels) and the International Physical Activity Questionnaire – Short Form (IPAQ-SF), Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10), FESS frequency data
When will data be available (start and end dates)?
Data will be available from the end of data collection and analysis (approximately 31/09/2023) and will be available for 5 yers
Available to whom?
Case-by-case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator (kade.davison@unisa.edu.au)


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.