Effects of a Wellbeing and Healthy Lifestyle Program for People with Rheumatoid Arthritis

INTERVENTION: The program will be delivered over 20 weeks by a multidisciplinary team with expertise and training in Clinical/Health Psychology (CHP), Exercise Physiology (EP), Nutrition and Dietetics (ND), and Tobacco Treatment Specialisation (TTS). Sessions will be at a university campus and include individual (in person and teleconference) and small group (n=3‐5) in person sessions to provide education, skills training, feedback, relevant resources and support. Individual assessments and planning sessions will be conducted to understand participant habits, contexts and preferences to tailor the lifestyle component programming. Resilience Training is provided first (weeks 1‐8) to introduce concepts, provide support on the impact of RA and to provide a foundation for coping strategies relevant across the other components. The smoking cessation component (where indicated) begins in week 5. The exercise and healthy components run concurrently in weeks 9‐16. The behaviour change counselling commences in week 11. Resilience Training (6 x 2 hr group sessions over 8 weeks). This group component is first to introduce concepts, provide support on the impact of RA and to provide a foundation for coping strategies relevant across the other components. Participants will have the option to invite a significant other to sessions. Sessions focus on the role of wellbeing in RA self‐management, mindfulness, acceptance, cognitive flexibility, life values and meaningful actions, accessing support, sleep and pleasurable activities. Sessions will make explicit links to relevance to lifestyle behaviours. Adherence will be assessed by interventionist records of participant attendance at sessions. Exercise Training (75mins individual planning session, 8 x 40 minutes small group t CONDITION: Diet and Nutrition ‐ Other diet and nutrition disorders Inflammatory and Immune System ‐ Rheumatoid arthritis Mental Health ‐ Other mental health disorders Physical Medicine / Rehabilitation ‐ Other physical medicine / rehabilitation Rheumatoid Arthritis;Poor Wellbeing/Quality of Life;Physical Inactivity;Unhealthy Diet;Cigarette Smoking; ; Rheumatoid Arthritis ; Poor Wellbeing/Quality of Life ; Physical Inactivity ; Unhealthy Diet ; Cigarette Smoking Public Health ‐ Health promotion/education PRIMARY OUTCOME: Quality of Life is assessed using the SF36 Mental and Physical Components of the SF‐36 which is administered as an online questionnaire[Within one month after program completion] Wellbeing is assessed using the Personal General Wellbeing Index, which is administered as an online questionnaire ; ; ; ; [Within one month after program completion] Physical activity (time spent in activity in the past week) is assessed via self report using National Health Survey items via an online questionnaire[Within one month after program completion ] ; INCLUSION CRITERIA: Participants are adults with a diagnosis of RA according to 2010 criteria, where the disease has been managed with conventional or biologic disease modifying drugs (cDMARDs, bDMARDs). (i) living in Brisbane area and able to access intervention site as scheduled, (ii) ambulatory, (iii) willing to attempt change in lifestyle behaviours as an adjunct to RA medication. SECONDARY OUTCOME: Neuromuscular strength is assessed using grip strength with a dynamometer. If assessment is done online, this will be dropped. [Within one month after program completion ] Anthropometry including assessor‐based measures of (i) height and weight to derive body mass index (BMI) and (ii) girths (waist, hip) using standard protocols. If assessment is done online, participants will be asked to self report height and weight, and may be mailed a tape measure for guided self assessment of girths.[Within one month after program completion ] Physical strength endurance is assessed using the 30s Sit to Stand Test. If assessment is done online, the 2min Step in Place Test will be used instead. [Within one month after program completion ] Fidelity of intervention implementation is assessed using feedback from the interventionists regarding delivery against protocol.[Written will be obtained from interventionists within two months after program completion, using questionnaires designed specifically for this project. Interventionists will also be invited to provide verbal feedback in a semi structured 1‐1 interview] PRIMARY OUTCOME: Smoking cessation assessed by self‐report. Online questionnaire items assess cigarettes smoked, nicotine dependence, quitting self‐efficacy i.e. confidence about making another quit attempt.[Within one month after program completion ] Physical power is assessed using the Timed‐Up & Go test (TUG) . If assessment is done online, the TUG will be dropped [Within one month after program completion ] Physical function is assessed using 6‐Minute Walk Test (6MWT) as a measure of exercise capacity. If assessment is moved online, the 2min Step in Place Test will be used. [Within one month after program completion ] PRIMARY OUTCOME: Diet quality assessed via a telephone administered dietary intake interview and questionnaire (Mediterranean Diet Adherence Score: https://predimedplus.com/en/), and data from a 3 day online food diary (Research Food Diary‐ Xyris Software) ; [Within one month after program completion ] Acceptability is assessed via participant online questionnaires specifically designed for this study. Items assess satisfaction with and perceived helpfulness of the program overall and specific program components, as well as the mode, duration, and frequency of program sessions. [Within one month after program completion ] Feasibility is assessed using study records to determine the proportion of people recruited to the trial as a function of a priori targets; and attendance records to determine the proportion of participants (allocated to the intervention condition) attending program sessions as a function of the number of scheduled sessions, and the proportion of participants (allocated to the intervention condition) completing the program as a function of the number enrolled.[Assessment will be conducted during the program, aligning with program components and sessions.] PRIMARY OUTCOME: Physical activity (time spent in activity in the past week) assessed objectively via accelerometry over one week[Within one month after program completion ] Safety is assessed as the number of adverse study related events and adverse consequences related to the program targets. Potential examples include exercise‐related injury, disease exacerbation, adverse reactions to smoking cessation aids. This will be assessed via participant self report in response to interventionist verbal queries monitoring during program sessions (for those allocated to the intervention condition), and participant self report on the post intervention questionnaire (all participants).[Information on adverse events will be collated from participants via verbal self report in response to interventionist verbal queries during program sessions and individual follow up after sessions as required (for those allocated to the intervention), and on the post intervention questionnaire (all participants) using items specifically designed for this study. ]