Secondary prevention of stroke. A physical activity and diet pilot randomised controlled trial

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.