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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.<\/jats:p><jats:p>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 \u2264 Disease Activity Score [DAS28] \u2264 5.1, RCT 1, <jats:italic>n<\/jats:italic> = 80), for patients at risk for RA, defined by ACPA-positive arthralgia (RCT 2, <jats:italic>n<\/jats:italic> = 16) and for patients with metabolic syndrome and OA in the knee and\/or hip (RCT 3, <jats:italic>n<\/jats:italic> = 80). After personal counseling on diet and exercise, participants join 10 group meetings with 6\u201312 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\u2009weeks 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.<\/jats:p>","DOI":"10.1186\/s13063-021-05682-y","type":"journal-article","created":{"date-parts":[[2021,10,18]],"date-time":"2021-10-18T19:28:00Z","timestamp":1634585280000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["The effect of a multidisciplinary lifestyle program for patients with rheumatoid arthritis, an increased risk for rheumatoid arthritis or with metabolic syndrome-associated osteoarthritis: the \u201cPlants for Joints\u201d randomized controlled trial protocol"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2428-2845","authenticated-orcid":false,"given":"Wendy","family":"Walrabenstein","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marike","family":"van der Leeden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Weijs","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Henri\u00ebt","family":"van Middendorp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlijn","family":"Wagenaar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Johanna Maria","family":"van Dongen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Max","family":"Nieuwdorp","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Catharina Sophia","family":"de Jonge","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurette","family":"van Boheemen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dirkjan","family":"van Schaardenburg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,10,18]]},"reference":[{"issue":"8","key":"5682_CR1","doi-asserted-by":"publisher","first-page":"1357","DOI":"10.1136\/annrheumdis-2016-210431","volume":"76","author":"Y Hu","year":"2017","unstructured":"Hu Y, Sparks JA, Malspeis S, Costenbader KH, Hu FB, Karlson EW, et al. 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The trial was prospectively registered in the Netherlands Trial Register () with identification numbers NL7800, NL7801, and NL7802 for the RA, MSOA, and APCA-positive arthralgia trials respectively. The trial registry includes all items from the World Health Organization Trial Registration Set and keeps an audit trail. All participants give written informed consent (including consent for collection and use of participant data) to the involved researchers or research associate. Subjects are informed about data storing and handling and are guaranteed on the discrete handling of their data (including pseudonymisation of body materials).The trial was classified as \u201clow-risk\u201d by the Medical Ethical Committee and does not involve ancillary and post-trial care or compensation for any harm from those who suffer from trial participation. Medical care as needed will be supplied to the subject who discontinues the study. For subjects who discontinue the study due to the occurrence of adverse events potentially related to the intervention, follow-up will take place until the adverse event has abated, or until a stable situation has been reached, with findings being recorded in CASTOR (the digital case report form). However, given the nature of the intervention, this is not expected.Due to the low risk level of this study monitoring is not mandatory. To ensure quality of this study, monitoring of source data handling will be performed locally. The monitoring will follow and check the standard operating procedure (SOP) of the Amsterdam University Medical Centers.Serious adverse events need to be reported till end of study within the Netherlands. The investigator will report all serious adverse events to the sponsor without undue delay after obtaining knowledge of the events. All other adverse events will be followed until they have abated, or until a stable situation has been reached. Depending on the event, follow-up may require additional tests or medical procedures as indicated and\/or referral to the general physician or a medical specialist.Patients can discontinue participation at any time. The general practitioner of the patient receives information on participation of the patient during start of the program. Patients will decide with their physician whether discontinuation is necessary. Subjects can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent medical reasons.The investigator\/sponsor will notify the accredited ethical medical committee of the (premature) end of the study or of a temporary halt (including the reason) within a period of 8\u2009weeks. Within 1 year after the end of the study, the investigator\/sponsor will submit a final study report with the results of the study, including any publications\/abstracts of the study, to the accredited ethical medical committee.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"The authors declare no competing interests.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"715"}}