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Trial registered on ANZCTR


Registration number
ACTRN12620000189921
Ethics application status
Approved
Date submitted
4/02/2020
Date registered
19/02/2020
Date last updated
19/02/2020
Date data sharing statement initially provided
19/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Secondary prevention of stroke. A physical activity and diet pilot randomised controlled trial
Scientific title
ENAbLE- Pilot. Secondary prevention of stroke. A physical activity and diet pilot randomised controlled trial
Secondary ID [1] 300093 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ENAbLE- Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 315618 0
Transient Ischaemic Attack (TIA) 315958 0
Condition category
Condition code
Stroke 313913 313913 0 0
Haemorrhagic
Stroke 313914 313914 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 4 arm pilot trial (with 3 intervention arms and one control arm). All arms of the trial are delivered via telehealth using teleconferencing technology. The interventions run 6 months duration with follow-up at 12 months. It aims to support participants to meet the minimum recommended levels of physical activity (150 min/week moderate to vigorous physical activity) through supervised exercise sessions and/or to adhere to Mediterranean dietary pattern through individual diet counselling sessions both of which are supported by evidence-based behaviour change strategies. All participants will undergo an initial telehealth session to trouble shoot technical issues and receive instructions on using monitoring devices.
Arm 1: Physical Activity Arm:
Materials. Participant information booklets (designed specifically for this study); Blood pressure monitor; Pulse oximeter; Borg CR-10 scale; ActivPAL; equipment to monitor physical activity (e.g Fitbit and/or physical activity diary) tailored to individual participant’s needs/preferences.
Procedures
• Initial telehealth exercise session (discuss exercise and information delivery preferences; assess participant ability; provide information re intervention; education regarding benefits of physical activity, discussion of program aims and strategies to optimise physical activity levels)
• Optional, home visit conducted at the discretion of the clinician if deemed necessary to ensuring participation in the trial
• Individually tailored, supervised, telehealth exercise sessions which aim to include a: wellness check; warm up; 20 minutes of moderate to vigorous physical activity; cool down
• Discussion/support/behavior change to achieve the target 150 minutes of moderate to vigorous physical activity per week (months 1-6).
• Therapist assistance or, local volunteers or support services to support participants in accessing programs to continue physical activity (months 4-6)
• Optional peer support via telehealth: Frequency to be negotiated with participants
Who: delivered by a physiotherapist or exercise professional with experience in stroke care who has undertaken Healthy Conversations training.
Delivery Mode- telehealth (video conference)
Dosage:
Months 1-3: 2 telehealth exercise sessions/week
Months 4-6: Individually tailored home and community physical activity program with once-weekly telehealth support which may include: Continuing the in-home exercise sessions; attending local stroke-specific or general exercise classes in the community; or walking groups;
Duration of all telehealth exercise sessions: 30-45 minutes
Location: Home-based telehealth sessions
Exercises may include marching or stepping on the spot, moving from sitting to standing (sit to stand repetitions), 1/2 or 1/4 squats, lifting small weights (such as tins of food) or walking. Exercises will be adapted to suit participants' ability and fitness level by trial therapists.

Arm 2: Diet Arm
Materials
Resources: recipe book, participant manual with Mediterranean diet pattern education materials, example menu plan and shopping list and templates for individual menu plan and shopping lists (resources developed specifically for this study).
A starter pack of foods staple to the Mediterranean diet pattern including olive oil, unsalted nuts, nut butters, wholegrain breakfast cereals, lower sodium wholegrain breads, canned fruit and fish. All other food will be provided by the participant.
Procedures
• 10 individual diet counselling sessions delivered via telehealth by trial therapists. Sessions will focus on the advantages of the AusMed diet in reducing recurrent stroke risk factors and setting personalised nutrition-focused goals and strategies using the Behaviour Change Wheel Framework.
• Focus on education: Mediterranean diet pattern, use of resources and how to individualise to fit in with current capabilities and lifestyle, program overview and aims, preferred frequency of behaviour change prompts (weeks 1-2);
• Focus on setting goals and strategies for adherence, providing feedback, skill development for self-efficacy (remainder of months 1-3);
• Focus on developing strategies to support adherence post intervention to maintain dietary change (months 4-6)
• Behaviour change prompts to support behaviour change delivered via SMS at a frequency negotiated with participant based on the COM-B model.
• Optional peer support via telehealth: Frequency to be negotiated with participants

Who
Delivered by Accredited Practicing Dietitians who have undertaken Healthy Conversations training.
Delivery Mode- telehealth (video conference)
Dosage:
• Months 1-3: Weeks 1-2 , one session /week, then fortnightly (7 sessions)
• Months 4-6: Monthly sessions (3 sessions):
Location: Home-based telehealth sessions
Session duration: 30-60 minutes

Arm 3: Physical Activity and Diet Arm
Participants will receive both the PA and DIET interventions as above.
Scheduling of intervention sessions will be dictated by participant preference and may occur as back-to-back appointments or at separate times/days.
Optional peer support via telehealth: Frequency to be negotiated with participants

Dosage:
Participants will receive 6 telehealth sessions in the first fortnight, then a maximum of 5 telehealth sessions per fortnight for the remainder of months 1-3, then fading to 5 sessions per month (months 4-6), with the opportunity for additional peer support.

Fidelity data collected will involve recording a selection of PA and DIET intervention sessions and coding them according to behaviour change techniques. In addition, at each exercise intervention session exercise dosage data will be collected.
Semi-structured interviews with trial participants and intervention therapists will explore acceptability of the interventions and their ability to facilitate behaviour change.

Intervention code [1] 316365 0
Lifestyle
Intervention code [2] 316453 0
Prevention
Comparator / control treatment
Arm 4: Control Arm will receive
• Education:
- Via hard-copy resources and links to online websites.
Hard Copies to be provided include: i) the Australia Government and NHMRC’s “Australian Guide to Healthy Eating” ( https://www.eatforhealth.gov.au/guidelines/australian-guide-healthy-eating), ii) Australian Department of Health’s “More than half of all Australian adults are not active enough” (https://www1.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-phys-act-guidelines#npa1864)
Website links include The Australia Government and NHMRC’s “Australia Dietary Guidelines ( https://www.eatforhealth.gov.au/ ), and the Australian Department of Health’s Australian Physical Activity and Sedentary behaviour Guidelines and the Australian 24-Hour Movement Guidelines ( https://www.health.gov.au/internet/main/publishing.nsf/Content/health-pubhlth-strateg-phys-act-guidelines )
- Advice based on the above resources above via 2 telehealth sessions at months 1 and 3, delivered by intervention therapists.

Control group
Active

Outcomes
Primary outcome [1] 322300 0
Measures of feasibility: including: number of participants screened, recruitment rates (site specific and overall), consent rates, participant demographics, acceptability (qualitative interviews), retention rate, time from screening to first intervention session, completion of consent documentation, completion of assessment data, adherence to treatment and assessment schedules, duration of assessment procedures, adverse events, optional home visits – frequency, reason for and outcome, optional peer support – uptake and acceptability/positive and negative feedback, proportion of session run within usual ‘business hours’ for allied health clinicians (8-5).
Timepoint [1] 322300 0
3 months and 6 months (primary time point) post-intervention
Primary outcome [2] 322519 0
Safety of the trial as measured by adverse events which may include falls, injuries, gastrointestinal issues requiring medical review or cardiac events. Trial therapists will record any adverse events that occur during telehealth sessions, and participants will answer a study specific questionnaire at the commencement of each exercise session, and at each assessment to self- report any adverse events that occur at other times during the study.
Timepoint [2] 322519 0
Throughout the intervention (0-12 months).
Secondary outcome [1] 378013 0
Change in systolic blood pressure measured with a portable blood pressure monitor, to be measured twice in the morning and afternoon for 7 days consecutively (minimum 3 days or 6 measures required to be used in the project evaluation).
Timepoint [1] 378013 0
3, 6 and 12 months after baseline assessment
Secondary outcome [2] 378808 0
Physical activity, as measured by the ActivPal to be worn continuously for 7 consecutive days (minimum of 3 days data required to be used in the evaluation)
Timepoint [2] 378808 0
3months, 6months, and 12 months after baseline assessment
Secondary outcome [3] 378809 0
Self-reported physical activity as measured by the International Physical Activity Questionnaire
Timepoint [3] 378809 0
3 months, 6 months and 12 months after baseline assessment
Secondary outcome [4] 378810 0
Change in health-related quality of life, as measured by EQ-5D-5L
Timepoint [4] 378810 0
3 months, 6 months and 12 months after baseline assessment
Secondary outcome [5] 378811 0
Change in fatigue measured by the Fatigue Severity Scale (FSS)
Timepoint [5] 378811 0
3 months, 6 months and 12 months after baseline
Secondary outcome [6] 378821 0
Change in depression, anxiety and stress, as measured by the Depression Anxiety Stress Scale 21 (DASS21).
Timepoint [6] 378821 0
3, 6 and 12 months after baseline assessment
Secondary outcome [7] 378867 0
Change in dietary intake as measured by the Mediterranean Diet Score (MDS) and the Australian Eating Survey (AES).
Timepoint [7] 378867 0
3, 6 and 12 months after baseline assessment

Eligibility
Key inclusion criteria
(i) Aged over 18 years
(ii) Self-reported stroke or TIA between 3 months to 10 years ago
(iii) Living at home
(iv) Able to walk independently at least short distances, based on participant self-report.
(v) Sufficient cognitive ability and/or carer support to engage in the interventions
(vi) Access to stable internet connection which can adequately support telehealth service
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Living in residential care
(ii) Unstable cardiac conditions, severe arthritis or other conditions limiting the ability to exercise
(iii) Food allergies limiting the ability to adhere to the AusMed diet
(iv) Difficulties swallowing (dysphagia)
(v) Already meeting physical activity guidelines (score =“moderate” International Physical Activity Questionnaire
(vi) Already adhering to a Mediterranean-style diet, indicated by a Mediterranean Diet Score Survey
(vii) Enrolled in another physical activity or diet intervention trial.

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 using Redcap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomistation, stratified by living location (city or rural/remote)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Feasibility:
Descriptive statistics of feasibility outcome measures will be used. Raw count (number, %) and mean (95% confidence interval) will be reported for categorical and continuous outcomes respectively. The data will be analysed as a whole, with further subgroup analysis for each arm of the trial.
Outcomes of effect:
Participants’ secondary stroke risk outcomes will be reported as estimates of mean differences with 95% confidence intervals. Analysis will be via a linear mixed model, adjusted for strata that includes baseline, mid-intervention (3 month) and end-intervention (6 month) measures. If there is no interaction, the trial arms will be collapsed to allow comparisons of PA vs control (with DIET balanced between arms) and DIET vs control (with PA balanced). Given that additional data will be collected at follow-up (12 months), secondary analysis will be conducted extending the linear mixed models to include the additional time point, including random effects for person and fixed effects for groups. Caution will be taken in interpreting the results or lack of any signal effect due to the limitations of the sample size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment hospital [1] 15563 0
Sunshine Hospital - St Albans
Recruitment hospital [2] 15564 0
Williamstown Hospital - Williamstown
Recruitment hospital [3] 15565 0
Footscray Hospital - Footscray
Recruitment postcode(s) [1] 28937 0
3021 - St Albans
Recruitment postcode(s) [2] 28938 0
3016 - Williamstown
Recruitment postcode(s) [3] 28939 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 304539 0
Charities/Societies/Foundations
Name [1] 304539 0
Stroke Foundation
Address [1] 304539 0
Head Office
Level 7, 461 Bourke Street
Melbourne VIC 3000
Country [1] 304539 0
Australia
Funding source category [2] 304540 0
Charities/Societies/Foundations
Name [2] 304540 0
Nancy and Vic Allen Stroke Prevention Foundation
Address [2] 304540 0
PO Box 201
Broadbeach QLD 4218
Country [2] 304540 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW
2308
Country
Australia
Secondary sponsor category [1] 304808 0
None
Name [1] 304808 0
NA
Address [1] 304808 0
NA
Country [1] 304808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304968 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 304968 0
Hunter New England Research Ethics & Governance Office
Locked Bag No 1, New Lambton NSW 2305
Ethics committee country [1] 304968 0
Australia
Date submitted for ethics approval [1] 304968 0
29/07/2019
Approval date [1] 304968 0
18/12/2019
Ethics approval number [1] 304968 0
2019/ETH11533

Summary
Brief summary
Adequate physical activity and a healthy diet are important in reducing the risk of having a stroke. Stroke recurrence is common and medical management alone is not sufficient to manage the risk of stroke recurrence. This study aims to test the safety and feasibility of a diet and/or exercise program for stroke survivors aimed at reducing their risk of having another stroke. The programs run for 6 months duration.
Both the diet and the exercise programs will be delivered via telehealth using teleconferencing technology, and this should make the program accessible to people who have had a stroke or transient ischaemic attack (TIA) all over Australia.
We will be assessing how feasible the programs are by measuring the rate we can recruit people to the study, participants’ adherence to the programs and the completion rate by participants. We will also be asking participants about their experience to identify if improvements can be made. We will also be measuring each participants’ risk of having another stroke by measuring the amount of physical activity they do, their diet, and their blood pressure. If successful this study will be used to support further research in the area.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98802 0
Prof Coralie English
Address 98802 0
University of Newcastle
School of Health Sciences
University Drive
Callaghan NSW
2308
Country 98802 0
Australia
Phone 98802 0
+61 2 4913 8102
Fax 98802 0
Email 98802 0
coralie.english@newcastle.edu.au
Contact person for public queries
Name 98803 0
Prof Coralie English
Address 98803 0
University of Newcastle
School of Health Sciences
University Drive
Callaghan NSW
2308
Country 98803 0
Australia
Phone 98803 0
+61 2 4913 8102
Fax 98803 0
Email 98803 0
coralie.english@newcastle.edu.au
Contact person for scientific queries
Name 98804 0
Prof Coralie English
Address 98804 0
University of Newcastle
School of Health Sciences
University Drive
Callaghan NSW
2308
Country 98804 0
Australia
Phone 98804 0
+61 2 4913 8102
Fax 98804 0
Email 98804 0
coralie.english@newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Researchers who provide a methodologically sound proposal, case-by-case basis at the
discretion of Primary Sponsor
Available for what types of analyses?
Only to achieve the aims in the approved proposal, for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof Coralie English coralie.english@newcastle.edu.au),
What supporting documents are/will be available?
Study protocol
Clinical study report
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6172 0
Study protocol
Citation [1] 6172 0
via Principal Investigator (Prof Coralie English coralie.english@newcastle.edu.au),
Link [1] 6172 0
Email [1] 6172 0
coralie.english@newcastle.edu.au
Other [1] 6172 0
Attachment [1] 6172 0
Type [2] 6174 0
Ethical approval
Citation [2] 6174 0
via Principal Investigator (Prof Coralie English coralie.english@newcastle.edu.au),
Link [2] 6174 0
Email [2] 6174 0
coralie.english@newcastle.edu.au
Other [2] 6174 0
Attachment [2] 6174 0
Summary results
No Results