A MEDiterranean Diet in Rheumatoid Arthritis

A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Behavioral: Mediterranean Diet Group; Behavioral: Healthy Eating Group

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Limerick, Ireland, V94 F858
    • University Hospital Limerick

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mediterranean Diet Group (Group A); 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; Participants will be advised to follow a traditional Mediterranean diet
Experimental: Healthy Eating Group (Group B); 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; Participants will be advised to follow the Healthy Eating Guidelines in Ireland

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Limerick
• Investigators: Principal Investigator: Audrey Tierney, Unievrsity of Limerick

Publications and helpful links

General Publications

• Raad T, George E, Griffin A, Larkin L, Fraser A, Kennedy N, Tierney A. A randomised controlled trial of a Mediterranean Dietary Intervention for Adults with Rheumatoid Arthritis (MEDRA): Study protocol. Contemp Clin Trials Commun. 2022 May 3;28:100919. doi: 10.1016/j.conctc.2022.100919. eCollection 2022 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2020
• Primary Completion (Actual): October 6, 2021
• Study Completion (Actual): October 6, 2021

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Randomised controlled trial; Mediterranean diet; Ireland
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: MEDRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No