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Abstract Background Plants for Joints (PFJ) is a multidisciplinary intervention centered around a whole-food plant-based diet, physical activity, and sleep and stress management. The PFJ intervention successfully improved disease activity and symptoms in people with rheumatoid arthritis (RA) or osteoarthritis (OA), respectively, and metabolic health. To investigate how these effects were achieved a mixed methods process evaluation was conducted to understand the context, implementation, and mechanism of impact of the PFJ intervention. Also, the relationship between degree of implementation and lifestyle changes was explored. Methods Quantitative and qualitative data were collected across the evaluation domains context (i.e. reach), implementation (i.e. recruitment and delivery), and mechanism of impact (i.e. responsiveness) of both the participants and coaches (incl. dietitians, sport coaches) according to the UK MRC guidelines for process evaluations. Data was collected from the participants via focus groups and questionnaires after the intervention, and interviews with coaches. Qualitative data were analyzed thematically, and quantitative data were assessed with descriptive statistics and linear regression analyses. Degree of implementation was quantified using a theory-driven implementation index score composed of different process evaluation constructs. Results Of the 155 participants who participated in the PFJ intervention, 106 (68%) took part in the questionnaire and 34 (22%) attended a focus group. Participants felt the intervention was complete, coherent, and would recommend the intervention to others (mean score 9.2 (SD 1.4) out of 10). Participants felt heard and empowered to take control of their lifestyle and health outcomes. Components perceived as most useful were self-monitoring, social support, practical and theoretical information, and (individual) guidance by the multidisciplinary team. Participants perceived the intervention as feasible, and many indicated it effectively improved their health outcomes. In an explorative analysis there was no significant difference in healthy lifestyle changes across implementation index score groups. Conclusion This process evaluation offers important insights into why the PFJ intervention works and how the intervention can be optimized for future implementation. Results indicating the intervention’s high satisfaction, feasibility, and perceived effectiveness, further support the use of plant-based lifestyle interventions as an additional treatment option for patients with RA, OA, or other chronic diseases. Trial registration International Clinical Trial Registry Platform numbers: NL7800, NL7801, and NL7802, all registered 17-06-2019.

Objectives In two randomised controlled trials, the Plants for Joints (PFJ) multidisciplinary lifestyle intervention reduced signs and symptoms of rheumatoid arthritis (RA), or metabolic syndrome-associated hip or knee osteoarthritis (MSOA) compared with usual care. The current study investigated long-term outcomes.Methods After completion of two 16-week trials in people with (1) RA or (2) MSOA, control groups switched to the active PFJ intervention. At the end of the intervention, all participants were followed up in a 1-year observational extension study. Primary outcomes were 28-joint Disease Activity Score (DAS28) (RA) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (MSOA). Secondary outcomes included body composition, metabolic outcomes, medication changes and intervention adherence. An intention-to-treat analysis with a linear mixed model was used to analyse within-group changes.Results 65 (84%) of 77 RA participants and 49 (77%) of 64 MSOA participants completed the extension study. The effects of the PFJ intervention were replicated in the original control groups and sustained within the RA group a year after intervention completion (mean DAS28 –0.9 points; p

Abstract Low-grade inflammation and metabolic syndrome are seen in many chronic diseases, including rheumatoid arthritis (RA) and osteoarthritis (OA). Lifestyle interventions which combine different non-pharmacological therapies have shown synergizing effects in improving outcomes in patients with other chronic diseases or increased risk thereof, especially cardiovascular disease. For RA and metabolic syndrome-associated OA (MSOA), whole food plant-based diets (WFPDs) have shown promising results. A WFPD, however, had not yet been combined with other lifestyle interventions for RA and OA patients. In this protocol paper, we therefore present Plants for Joints, a multidisciplinary lifestyle program, based on a WFPD, exercise, and stress management. The objective is to study the effect of this program on disease activity in patients with RA (randomized controlled trial [RCT] 1), on a risk score for developing RA in patients with anti-citrullinated protein antibody (ACPA) positive arthralgia (RCT 2) and on pain, stiffness, and function in patients with MSOA (RCT 3), all in comparison with usual care. We designed three 16-week observer-blind RCTs with a waiting-list control group for patients with RA with low to moderate disease activity (2.6 ≤ Disease Activity Score [DAS28] ≤ 5.1, RCT 1, n = 80), for patients at risk for RA, defined by ACPA-positive arthralgia (RCT 2, n = 16) and for patients with metabolic syndrome and OA in the knee and/or hip (RCT 3, n = 80). After personal counseling on diet and exercise, participants join 10 group meetings with 6–12 other patients to receive theoretical and practical training on a WFPD, exercise, and stress management, while medication remains unchanged. The waiting-list control group receives usual care, while entering the program after the RCT. Primary outcomes are: difference in mean change between intervention and control groups within 16 weeks for the DAS28 in RA patients (RCT 1), the RA-risk score for ACPA positive arthralgia patients (RCT 2), and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) score for MSOA patients (RCT 3). Continued adherence to the lifestyle program is measured in a two-year observational extension study.