The Feasibility and Acceptability of a Plant-Based Diet in People With Rheumatoid Arthritis - A Randomized Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires
研究概览
简要总结
In this feasibility study, our primary goal is to assess the practicality of implementing a plant-based food diet intervention for individuals with rheumatoid arthritis (RA). The intervention consists of three key components: 1) Educational materials (videos), 2) Participation in a cooking workshop introducing plant-based meals, complete with recipes, and 3) Daily delivery of plant-based dinner meals over a four-week period. This comprehensive investigation covers the testing of recruitment procedures, randomization, intervention elements, outcome assessments, and participant retention.
Adopting a daily plant-based diet involves introducing several new plant-based foods and making adjustments to the existing diets of patients with RA. Consequently, the feasibility study will also aim to explore the acceptability of the intervention and whether a full-scale RCT is practically possible.
详细描述
Rheumatoid arthritis (RA) is a common chronic autoimmune disease requiring lifelong pharmacological treatment and causing significant burden to the patient and society. Evidence has suggested that it is important that patients take an active role in their self-management to improve their overall health and quality of life. Effective self-management strategies often involve changes in lifestyle. We have previously conducted a lifestyle intervention study to reduce sedentary behavior and increase physical activity in 150 patients with RA. An individually tailored intervention motivating patients to self-manage their arthritis by reducing sedentary behavior and replacing it with light-intensity physical activity reduced disease activity, e.g., levels of pain and fatigue. Nutrition may be another important part of self-management strategies in patients with RA. Emerging evidence suggests that an anti-inflammatory diet may reduce disease activity and improve quality of life among patients with RA.3 Compared to a diet including animal foods, a Plant-Based Diet (PBD) is believed to include less of the pro-inflammatory, and more of the anti-inflammatory, ingredients, and thus may have the potential to reduce disease activity in patients with RA.
Our overall and long-term aim is to test and evaluate the effect of a PBD intervention on disease activity in patients with RA in a later randomized controlled trial (RCT). As a first step towards this, we wish to investigate strengths and limitations of the planned intervention, which introduces a PBD to patients with RA.
Thus, in a feasibility study, we aim to investigate the feasibility of the intervention, including recruitment procedures, randomization, intervention elements, outcome assessments and retention. Following a daily PBD will involve inclusion of several new plant-based foods and changes in earlier diets for patients with RA. As such, the feasibility study will also aim to investigate acceptability of the intervention, including how people with RA respond to the intervention elements and how a PBD affect their daily lives (e.g. how easy is it to prepare plant-based foods, how desirable is it to eat, and how does it affect digestion). Ultimately, the findings from this feasibility study will provide crucial insights into whether a full-scale randomized controlled trial (RCT), designed to evaluate the effects of a 100% plant-based diet on patients with RA, is a feasible and realistic undertaking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Not possible to blind participants and study staff delivering the intervention to allocation status, whereas all outcome data is planned to be collected by blinded outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease Activity Score with 28 Joint Counts (DAS28) between 2.0-3.2
- •A rheumatoid arthritis diagnosis of minimum 1 year
- •Under stable pharmaceutical treatment for at least 4 months and with no planned change in treatment within 8 weeks
排除标准
- •Daily smokers
- •Diabetes Mellitus
- •Pregnancy / planned pregnancy
- •Lactation
- •Prednisolone treatment
- •DAS28 below 2.0 and above 3.2
- •Current dietary habits resembling intervention diet (e.g., 100% plant based diets)
- •Participation in other intervention studies or clinical trials via the rheumatology outpatient clinic that will affect their adherence to plant based diets
- •Not able to eat ad libitum meals because of e.g., allergy
- •Unable to understand the informed consent and study procedures
- •Alcohol and/or drug abuse
研究组 & 干预措施
Control group
The control group will be asked to maintain habitual diet and lifestyle. In addition, they will follow the same outcome assessments as the intervention group.
Intervention group
As part of the 4-week intervention in the feasibility study, the intervention group will receive 1) Educational materials (videos) 2) Participation in a cooking workshop with introduction to PBD meals, including recipes, and 3) Daily delivered PBD dinner meal during the four weeks.
干预措施: Intervention with 100% plant-based diet (Other)
结局指标
主要结局
Evaluation of Feasibility and Intervention Fidelity in Implementing a Plant-Based Food Diet Intervention - Evaluating the feasibilty of included objectively measured outcomes and self-administered questionnaires
时间窗: 3 months
This study aims to evaluate the feasibility of implementing a plant-based food diet (PBD) intervention by assessing participant acceptability and feasibility in achieving desired outcomes. Feasibility testing will involve specific objective outcome assessments, including both objectively measured outcomes and self-administered questionnaires outlined below as secondary outcomes.
Retention
时间窗: 3 months
Retention rates will be calculated as the proportion of patients providing the outcomes of interest/proportion of patients randomised
Evaluation of Study Acceptance
时间窗: 3 months
This study assesses the acceptability of the study protocol from qualitative methods through focus group interviews, exploring topics such as the effectiveness of food delivery methods and participants' perceptions of the plant-based diet intervention.
Recruitment
时间窗: 3 months
Recruitment rates will be calculated as the proportion of patients randomised/proportion of patients eligible
Intervention adherence
时间窗: 3 months
Adherence of intervention protocol will be calculated as the number of received optional elements of the intervention out of the total number of optional intervention elements available
次要结局
- Pain (VAS)(3 months)
- Disease Activity Score (DAS28)(3 months)
- Sleep(3 months)
- Impact of rheumatoid arthritis (RA)(3 months)
- The EuroQuality of Life (EQ-5D)(3 months)
- Height(3 months)
- C-reactive Protein (CRP)(3 months)
- Fatigue: Bristol Rheumatoid Arthritis Fatigue (BRAF MDQ)(3 months)
- Anxiety/depression(3 months)
- Disease activity(3 months)
- Body composition(3 months)
- Low-density lipoprotein (LDL)(3 months)
- Total cholesterol(3 months)
- Physical function(3 months)
- Weight(3 months)
- Waist- and hip circumference(3 months)
- Quantification of tender and swollen joints(3 months)
- Hemoglobin (HbA1c)(3 months)
- Triglyceride(3 months)
- Leukocytes(3 months)
- D-vitamin(3 months)
- Hemoglobin(3 months)
- Thrombocytes(3 months)
- High-density lipoprotein (HDL)(3 months)
研究者
Allan Linneberg
Director, Professor, MD, PhD
Bispebjerg Hospital