A MEDiterranean Diet in Rheumatoid Arthritis (MEDRA)
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
- 是
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
Tala Raad
PhD Candidate
University of Limerick
