RecruitingACTRN12622000507785

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


Sponsor

Griffith University

Enrollment

25 participants

Start Date

Mar 14, 2022

Study Type

Interventional

Conditions

Summary

The aim of this project is to evaluate the impact, feasibility, acceptability of a wellbeing and healthy lifestyle program for adults with rheumatoid arthritis (RA). The program is delivered over 20 weeks by a multidisciplinary team and includes individual (in person and online/teleconference) and small group in person sessions to provide education, skills training, feedback, resources and support related to psychological resilience, exercise, healthy eating, cigarette smoking cessation and behaviour change. Assessment is done before and within 1 month after the program using online questionnaires, measures of physical functioning, a dietary interview and food diary, and physical activity monitoring. Questionnaires will be used to assess participant feedback on the program. It is hypothesised that program participants will describe the program positively and show more improvements in wellbeing, healthy lifestyle behaviours and physical functioning than those receiving usual care. The outcomes of this research will be used to review and revise the program and to design a larger trial.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Rheumatoid arthritis is a chronic condition where the body's immune system mistakenly attacks the joints, causing pain, stiffness, and swelling. While medications can help control the disease, living well with rheumatoid arthritis also depends heavily on lifestyle — staying active, eating well, managing stress, and avoiding smoking. This study is testing a comprehensive 20-week program that addresses all these areas together, delivered by a team of different health professionals. The program combines individual sessions (both in person and via telehealth) with small group meetings to provide education, skills training, and support. Areas covered include psychological resilience, exercise, healthy eating, and stopping smoking. Participants are assessed before and after the program using questionnaires, physical tests, a dietary interview, and an activity tracker. You may be eligible if you are an adult living in the Brisbane area with a confirmed diagnosis of rheumatoid arthritis managed with disease-modifying drugs, are able to walk, and are willing to try making lifestyle changes alongside your medication. People with heart conditions that prevent exercise, significant mobility problems in the lower limbs, other autoimmune conditions, or who are already receiving psychological treatment are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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 Tob

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 training sessions, with 2 sessions per week on alternating weeks over 7 weeks). Individualised prescription is based on medical history, interests, limitations and suitability for self-direction. Small group supervised training targets recommendations of >150 mins/week of moderate or 75 mins/week of vigorous aerobic exercise, and muscle strengthening exercise. The aerobic training focuses on walking, and strength exercises will involve upper and lower limbs using body weight, fitball, therabands and small weights available in the home. Pool exercises may also be included if walking is challenging. Training intensity progresses according to participant preferences and ability. Intensity will be monitored using an approach that uses both heart rate monitors and RPE. Participants are provided with fitbits for behavioural monitoring and these also provide information on heart rate which can be used during supervised and self directed exercise training. Participants are supported to self-direct exercise, and be given a Fitbit for self-monitoring, exercise mat, fitball and therabands. Adherence will be assessed by interventionist records of participant attendance at sessions. Nutrition Counselling (45mins individual planning session, 4 x 30 minutes individual telephone sessions, on alternating weeks over 7 weeks). An interview, questionnaire based on intake of core food groups ( Mediterranean Diet Adherence Score) and data from a 3 day food diary (online app) is used to determine habitual dietary intake, including diet quality, eating pattern, food preferences, and alcohol intake. Energy requirements are estimated. Nutrition counselling focuses on personalised goals to target ideal weight balance and diet quality, based on healthy eating recommendations, and current evidence about pro and anti-inflammatory food constituents. Participants are provided with resources to guide food shopping, meal preparation, and target daily intake. Individualised “check-ins” where family are invited too, will assist in trouble-shooting of “road-blocks”. During two of these check in sessions with intervention participants, individualised dietary intake will be monitored by an interviewer assisted 24-hour recall interview. Adherence will be assessed by interventionist records of participant attendance at sessions. Behaviour Change Counselling (4 x 1 hour small group sessions on alternating weeks over 8 weeks). Small group-based sessions support lifestyle change advice. This is based on the 5A Behavioural Counselling Framework as an evidence-based approach appropriate for people with chronic conditions. Key components are (i) Assessment: e.g., perceived role of lifestyle in RA, experiences/barriers/enablers of change. (ii) Advice: clear recommendations. (iii) Agree: Collaborative goal setting; (iv) Assistance: Cognitive and behavioural strategies to support change (e.g., action planning, positive outcome expectations, problem-solving, adaptive interpretation of setbacks). (v) Arrange: Additional assistance/resources. Adherence will be assessed by interventionist records of participant attendance at sessions. Smoking Cessation Counselling (2 hour small group session, 45mins individual planning session, 5 x 15mins individual telephone sessions weekly over 5 weeks). (where indicated) An initial face to face small group session (n=3-5) is used to provide basic psychoeducation and smoking cessation principles. Individualised sessions include nicotine dependence assessment, quitting self-efficacy, carbon monoxide monitoring, lung age calculator, individual Quit Plan, education, support, and practical coping strategies. Participants are asked to personally arrange an appointment with a GP of their choice for a prescription for pharmacotherapy if they want to use prescription smoking cessation medication for their quit attempt. Over the counter stop smoking medications (Nicotine Replacement Therapy) are supplied as indicated and correct use demonstrated. Dosing is based on WHO “first line therapy” and RACGP guidelines. Prescription medicine options (Varenicline and Bupropion) will be supported in line with participant preferences and in consultation with the medical team. Adherence will be assessed by interventionist records of participant attendance at sessions.


Locations(2)

Princess Alexandra Hospital - Woolloongabba

QLD, Australia

Logan Hospital - Meadowbrook

QLD, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12622000507785


Related Trials