Diet Interventions in Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 3
- 主要终点
- Change in Disease Activity in Psoriatic Arthritis (DAPSA)
研究概览
简要总结
The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA).
详细描述
The study asks if dietary change and nutritional support improves disease activity and if patients are better able to improve or sustain progress with additional incentives. The study will use an online program to communicate with participants through text and online surveys. This 24-week trial will enroll 90 patients in the US and Canada with New York University as a back-up site.
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
- Single (Outcomes Assessor)
盲法说明
In a study assessing dietary behavioral interventions, absolute blinding of the participants is not possible because of obvious differences between intervention diets. However, we will avoid naming the allocated dietary intervention and withhold information about our research hypothesis from the patients. Participants in the control group will receive the same schedule of visits and patient reported outcomes. The study rheumatologists (outcome assessors) will be blinded to the allocated group and the participants will be asked to avoid discussing the details of their diet with them.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •Required Rheumatologist-confirmed diagnosis of PsA fulfilling Classification of Psoriatic Arthritis Criteria (CASPAR)
- •Willing to alter diet and participate for 24 weeks
- •Able to attend follow-up visits
- •Body mass index (BMI) > 25 and <40
- •No history of eating disorders such as anorexia or bulimia
- •Disease Activity in Psoriatic Arthritis Assessment (DAPSA) > 10
- •Stable treatment for PsA for ≥3 months prior to enrollment (patients may be on any disease modifying anti-rheumatic drugs (DMARDs) or they can be free of systemic medications
- •Owns and uses an iPhone or Android smart phone, or is willing to use a device provided by the study team
排除标准
- •Inability to provide informed consent
- •Plan to change systemic treatment for psoriasis or PsA in the next 4-8 weeks
- •Use of systemic corticosteroids
- •All persons who would be placed at an increased risk including any medical condition that will impair the ability of the person to participate in a nutritional intervention study (e.g. insulin dependent diabetes, use of coumadin, advanced malignancy, inflammatory bowel disease, dementia)
- •History of food allergy to any of the components of olive oil or nuts
- •Inability to read and write in English
- •Unwillingness to change dietary habits
- •Known pregnancy (pregnancy testing will be performed for women of childbearing age; weight changes will not accurately reflect the changes we would anticipate in pregnant patients and weight loss may be detrimental to maternal and/or fetal outcomes).
- •Participation in another physical activity study and/or diet trial
研究组 & 干预措施
Diet 3
Diet 3 will focus on healthy dietary patterns and provide nutritional support with a dietitian.
Diet 1
Diet 1 will focus on the dietary pattern and monitor types of foods, supplementary nutrition, and provide nutritional support with a dietitian.
干预措施: Diet 1 (Other)
Diet 2
Diet 2 will focus on the dietary pattern and monitor the amount of food, complimentary nutrition, and nutritional support with a dietitian.
干预措施: Diet 2 (Other)
结局指标
主要结局
Change in Disease Activity in Psoriatic Arthritis (DAPSA)
时间窗: 12 weeks
Disease Activity in Psoriatic Arthritis (DAPSA) is a total of the 5 elements listed below to assess disease activity from both clinical and patient-reported data. The total score falls within a range to indicate level of disease activity: 0-4 = Remission (minimum); 5-14 = Low; 15-28 = Moderate; \>28 = High Disease Activity. There is no theoretical upper limit to the DAPSA score. Total DAPSA score = TJ (Tender Joints) + SJ (Swollen Joints) + CRP (C-reactive protein) + Activity + Pain 1. Tender Joints Count (0-68 joints) 2. Swollen Joints Count (0-66 joints) 3. CRP (mg/dl) 4. Patient's assessment of disease activity and pain: 1. How active was your rheumatic disease on average during the last week? Scale of 1-10 (Not Active -Active) 2. How would you describe the overall level of joint pain during the last week? Scale of 1-10 (None-Very Severe)
次要结局
- Change in Psoriasis Area and Severity Index (PASI)(24 weeks)
- Patient Reported Outcomes-Skin Disease Impact(Varying times: (at Baseline) 0,12, 24 Weeks)
- Patient Reported Outcomes-Physical Function(Varying times: (at Baseline) 0,12, 24 Weeks)
- Metabolic Profile-Height(Varying times: (at Baseline) 0, 12, 24 Weeks)
- Patient Reported Outcomes-Depression(Varying times: (at Baseline) 0,12, 24 Weeks)
- Metabolic Profile- C-reactive protein(Varying times: (at Baseline) 0, 12, 24 Weeks)
- Preliminary Safety: Adverse event (AE)/ Serious Adverse Event (SAE)(12 Weeks, 24 Weeks)
- Metabolic Profile-Weight(Varying times: (at Baseline) 0, 12, 24 Weeks)
- Patient Reported Outcomes-Psoriatic Arthritis Disease Impact(Varying times: (at Baseline) 0, 4, 8, 12, 16, 20, 24 Weeks)
- Patient Reported Outcomes-Fatigue(Varying times: (at Baseline) 0, 4, 8, 12, 16, 20, 24 Weeks)
- Therapy changes(Chart review at 12 and 24 Weeks)
- Metabolic Profile-Blood Pressure(Varying times: (at Baseline) 0, 12, 24 Weeks)
- Metabolic Profile-Waist Measurement(Varying times: (at Baseline) 0, 12, 24 Weeks)
- Metabolic Profile- Blood Glucose Studies(Varying times: (at Baseline) 0, 12, 24 Weeks)
- Change in Disease Activity in Psoriatic Arthritis (DAPSA)(24 weeks)
- Patient Reported Outcomes-Psoriatic Arthritis Disease Impact(Varying times: (at Baseline) 0, 12, 24 Weeks)
- Patient Reported Outcomes-Fatigue(Varying times: (at Baseline) 0, 12, 24 Weeks)