A MEDiterranean Diet in Rheumatoid Arthritis

NCT04262505 | Completed

• 1 other identifier: MEDRA
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Keywords

Mediterranean diet; Randomised controlled trial; Ireland

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Diet adherence

  Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)

• Change in Physical activity levels

  Throughout the 12 week study period (At baseline, mid-intervention and post-intervention)

Study Arms (2)

Mediterranean Diet Group (Group A)

EXPERIMENTAL

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

Healthy Eating Group (Group B)

EXPERIMENTAL

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

Interventions

Mediterranean Diet Group BEHAVIORAL

Participants will be advised to follow a traditional Mediterranean diet

Mediterranean Diet Group (Group A)

Healthy Eating Group BEHAVIORAL

Participants will be advised to follow the Healthy Eating Guidelines in Ireland

Healthy Eating Group (Group B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 year
• Definite diagnosis of rheumatoid arthritis according to ACR or EULAR criteria
• Full access to Internet/smartphone
• English speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Limerick: lead

Study Sites (1)

University Hospital Limerick

Limerick, V94 F858, Ireland

Location

Related Publications (2)

• Raad T, George E, Griffin A, Larkin L, Fraser A, Kennedy N, Tierney A. Effects of a telehealth-delivered Mediterranean diet intervention in adults with Rheumatoid Arthritis (MEDRA): a randomised controlled trial. BMC Musculoskelet Disord. 2024 Aug 7;25(1):631. doi: 10.1186/s12891-024-07742-1.

  PMID: 39112976 DERIVED

• 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.

  PMID: 35620325 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Audrey Tierney

  Unievrsity of Limerick

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Due to the nature of dietary interventions, blinding will not be possible
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Mediterranean diet vs. Irish healthy eating guidelines

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: February 10, 2020
• Study Start: February 6, 2020
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: May 17, 2022

Record last verified: 2022-05

Locations

IE (1)