跳至主要内容
临床试验/NCT04262505
NCT04262505已完成不适用

A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)

University of Limerick2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Changes in Physical Function

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

盲法说明

Due to the nature of dietary interventions, blinding will not be possible

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Changes in Physical Function

时间窗: 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

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tala Raad

PhD Candidate

University of Limerick

研究点 (2)

Loading locations...

相似试验