A MEDiterranean Diet in Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT04262505
• Lead Sponsor: University of Limerick

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.

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 Timeline

• Study First Submitted: 2020-02-04
• Study First Submitted QC: 2020-02-05
• Study Start: 2020-02-06
• Study First Posted: 2020-02-10
• Primary Completion: 2021-10-06
• Study Completion: 2021-10-06
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Physical Function	Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)	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.
Changes in Quality of Life	Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Change in Diet adherence	Throughout the 12 weeks study period (At baseline, mid-intervention and post-intervention)	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
Change in Physical activity levels	Throughout the 12 week study period (At baseline, mid-intervention and post-intervention)	Assessment of participants' physical activity levels using the YPAS (Yale Physical activity survey)

Trial Locations

Locations (1)

University Hospital Limerick; 🇮🇪 Limerick, Ireland