Plants for Joints RA

Rationale:
An unhealthy lifestyle is associated with a higher risk of chronic diseases and conditions such as rheumatoid arthritis (RA). Low-grade inflammation is often present in people with unhealthy lifestyles and may be a key factor in the pathogenesis of chronic inflammatory diseases. Current treatment of RA mainly consists of medication. Combining different types of non-pharmacological therapies such as diet, exercise and stress management has shown synergizing effects in other chronic diseases. Whole foods plant-based diets (WFPDs) have shown promising results for the treatment of RA but were not yet combined with other lifestyle interventions.

Objective:
To investigate the effect of a multidisciplinary lifestyle program, based on a WFPD, exercise and stress management on disease activity in patients with RA. A one-year extension study will investigate continued adherence to lifestyle changes and measure to what extent it is possible to taper drug therapy for RA-patients in (near) remission.

Study design:
A 16-week randomized single-blind controlled trial (RCT), comparing a multidisciplinary lifestyle program with usual care in patients with active RA (n=80). The control group will be placed on a waiting list to receive the intervention after 16 weeks. After completion of the lifestyle program, all patients will be followed in a two-year extension study.

Study population:
RA patients with low to moderate disease activity (2.6≤DAS28≤5.1) and no or unchanged DMARD treatment for at least 3 months.

Intervention:
Personal counselling on diet and exercise, followed by 10 meetings in groups of 15 people with theoretical and practical training on a WFPD, exercise and stress management. The control group receives usual care. During the 16-week program the medication remains unchanged. During the one-year extension program subjects have 6 additional group meetings and – if in (near) remission – medication will be tapered in a standardized manner.

Main study parameters/endpoints:
The primary outcomes are: difference in mean change between intervention- and control group for the DAS28. For the two-year extension study the change in adherence from 0-24 months is the main endpoint.

A 16-week multidisciplinary lifestyle program, based on (1) a WFPD, (2) exercise and (3) stress management
H0: has no effect on the disease activity in patients with rheumatoid arthritis, in comparison with usual care.
H1: lowers disease activity in patients with rheumatoid arthritis more than usual care.

Start RCT: May 2019. End RCT: summer 2021. End extension study: summer 2023.

During the first visit, subjects will be randomized and baseline measurements will be taken. The first visit will be concluded with a personal intake meeting with a registered dietician and a physiotherapist to determine personal objectives (i.e. weight loss), as well as abilities and limitations regarding exercise.

During the 16-week lifestyle program subjects will meet 10 times (weekly from week 1-9 and the last meeting in week 13, with minor rescheduling in case of holidays) in groups of maximum 15 people. Participants are invited to bring their partner/spouse (or someone else who is able to support the patient in this program) to the first meeting (cooking class).

During all meetings (duration 2- 3 hours) subjects will receive theoretical and/or practical training, based on protocols tested in previous studies on the following topics:
1. Whole foods plant-based diet (e.g. workshops cooking).
2. Exercise (e.g. brisk walking and/or muscle strengthening exercises), based on the Dutch physical activity guidelines 2017.
3. Stress management (e.g. relaxation exercises).