A MEDiterranean Diet in Rheumatoid Arthritis

Study Overview
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Brief Summary
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The MEDRA study is a 12-week randomised controlled trial that aims to assess effects of a Mediterranean dietary telehealth intervention compared to the Irish Healthy Eating guidelines on the physical function and quality of life of adults living with Rheumatoid Arthritis in Ireland. Investigators will be able to determine how closely people living in Ireland can accept the Mediterranean dietary practices and adhere to them with dietetic input and guidance.

Detailed Description
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Rheumatoid arthritis (RA) is a long-term inflammatory disease which commonly occurs in the small joints of the hands, wrists and feet leading to swelling, pain and stiffness in the affected joints. The condition is two to three times more prevalent in women than in men. Although it might occur at any age, the incidence of the disease is highest between the ages of 40 and 65 years. Currently, there is no treatment that provides complete remission of the disease for people living with RA. Treatment of RA aims to reduce the symptoms and improve the health of the patient. Although diet is not part of the mainstream treatment, many studies have reported beneficial effects of certain diets on RA symptoms. The MEDRA study will examine the habitual dietary intakes of people living with RA in Ireland and will explore whether people with RA will benefit from either a Mediterranean dietary pattern or the Healthy eating guidelines in Ireland. This small scale study will provide useful information on whether people with RA in Ireland can adhere to a Mediterranean dietary pattern and whether the intervention will have beneficial impact on the physical function and quality of life. This is important work prior to proceeding to larger intervention studies.

Official Title
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A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Behavioral: Mediterranean Diet Group
* Behavioral: Healthy Eating Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 year Definite diagnosis of rheumatoid arthritis according to ACR or EULAR criteria Full access to Internet/smartphone English speaking Exclusion Criteria: Age <18 years Breastfeeding, pregnant or trying to get pregnant. Patients who have commenced nutritional supplements or a new dietary regime in the month prior to study enrolment. Patients who do not have access to the Internet/smartphone

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mediterranean diet vs. Irish healthy eating guidelines
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet Group (Group A)<br>The intervention is based on components of the traditional Mediterranean diet which is primarily a plant based diet and emphasises intakes of vegetables, whole grains and fruit with the main added fat being extra virgin olive oil.The diet will be modified and tailored to cultured preferences by the registered dietitian. Participants will be informed of their diet allocation group during the baseline teleconsultation and will commence the diet the following day or as soon as is feasible for 12 weeks. Participants will be provided with resources specifically designed to explain the components of the Mediterranean diet and how it will be followed. | Behavioral: Mediterranean Diet Group<br>* Participants will be advised to follow a traditional Mediterranean diet<br>|
| Experimental: Healthy Eating Group (Group B)<br>Participants assigned to the Healthy Eating group will be advised to adhere to the current healthy eating guidelines and will be provided with resources to inform them of these guidelines and sample meal plans that are readily available on the Healthy Ireland website. | Behavioral: Healthy Eating Group<br>* Participants will be advised to follow the Healthy Eating Guidelines in Ireland<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quality of Life | Rheumatoid Arthritis Quality of Life questionnaire (RAQoL) will be used to describe the individuals' perceptions, satisfaction, and evaluation of different areas of their own lives, such as physical health and functioning, psychological and emotional well-being, social roles, and relationships. A scale 1 to 30 will be used whereby the higher the score, the worse the QoL. | Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention) | 
| Changes in Physical Function | The health assessment questionnaire disability index (HAQ-DI) is an index used to assess how arthritis impacts the participant's everyday life. A scale 0-3 is used whereby 3 indicated very severe disability. | Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Diet adherence | Assessment of participants' adherence to either the Mediterranean diet or the current Irish Healthy Guidelines will be assessed using a PREDIMED validated checklist and a Healthy Eating checklist respectively. Higher scores indicate greater adherence to the diet assigned. A 3-day food diary will also be used to captures the dietary intake of participants | Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention) | 
| Change in Physical activity levels | Assessment of participants' physical activity levels using the YPAS (Yale Physical activity survey) | Throughout the 12 week study period (At baseline, mid-intervention and post-intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ireland, Mediterranean diet, Randomised controlled trial