Psoriatic Arthritis
Conditions
Keywords
PsA (Psoriatic Arthritis), Diet, Food, Nutrition
Brief summary
The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA).
Detailed description
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.
Interventions
OTHERDiet 1
Diet 1 will focus on which foods are eaten and the impact on disease outcomes.
OTHERDiet 2
This diet will limit the amount of food energy consumed each day and the impact on disease outcomes. This will be determined by factors including the subject's demographics (age, sex, weight, height).
Sponsors
University of Pennsylvania
Women's College Hospital
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
In this randomized controlled pilot trial, we will test different diets to determine the impact on disease outcomes among patients with psoriatic arthritis. This is a 24-week trial that will enroll 90 patients with active psoriatic arthritis despite stable therapy among three sites in the US and Canada. Dietary interventions will be enhanced with gamification, including feedback and competition. Biomarker samples including blood, urine and stool specimens will be collected and banked for exploratory analyses.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity in Psoriatic Arthritis (DAPSA) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity in Psoriatic Arthritis (DAPSA) | 24 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. DAPSA = 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) |
| Patient Reported Outcomes-Psoriatic Arthritis Disease Impact | Varying times: (at Baseline) 0, 12, 24 Weeks | -Psoriatic Arthritis Disease Impact- Psoriatic Arthritis Impact of Disease (PSAID). The PsAID is a measure developed by the European League Against Rheumatism (EULAR) and is composed of domains selected by an international group of patients with psoriatic arthritis. The questionnaire uses a weighted scoring system (weights were derived by patient impression of importance) and has a range of 0-10. A lower score indicates lower impact of disease from the patient perspective, and a score of 4 is considered a patient acceptable symptom state. |
| Patient Reported Outcomes-Fatigue | Varying times: (at Baseline) 0, 12, 24 Weeks | -Fatigue- PROMIS (Patient-Reported Outcomes Measurement Information System) Fatigue (CAT) The PROMIS Fatigue scale assesses fatigue experience and impact of fatigue over 7 days. The instrument includes items on exhaustion and ability to function normally in physical, social, mental and family roles and activities. This instrument has good content validity and responsiveness in rheumatoid arthritis, a similar inflammatory arthritis. We will use the CAT (Computerized Adaptive Test) response instrument. PROMIS uses Item Response Theory (IRT) statistical model that links individual questions to a presumed underlying trait or concept of global health represented by all items in the scale; instruments are scored using item-level calibrations ("response pattern scoring") in an online tool (T-Score range 0-100, where 50 is the mean with a standard deviation of 10). Increasing score indicates higher level of fatigue. |
| Metabolic Profile-Weight | Varying times: (at Baseline) 0, 12, 24 Weeks | Changes in Weight; Weight\_kg; Weight and Height will be combined to report BMI in kg/m\^2; Body Mass Index (BMI) \_ wt/h²; The standard weight status categories associated with BMI ranges for adults are listed as; BMI Weight Status: Below 18.5 Underweight 18.5 - 24.9 Normal or Healthy Weight 25.0 - 29.9 Overweight 30.0 and Above Obese Accessed on 11/19/19, https://www.cdc.gov/healthyweight/assessing/bmi/adult\_bmi/index.html#Interpreted |
| Metabolic Profile-Waist Measurement | Varying times: (at Baseline) 0, 12, 24 Weeks | Waist measurement\_cm |
Countries
Canada, United States
Contacts
PRINCIPAL_INVESTIGATORAlexis Ogdie-Beatty, MD, MSCE
University of Pennsylvania
PRINCIPAL_INVESTIGATORLihi Eder, MD, PhD
Women's College Hospital, University of Toronto
Participant flow
Pre-assignment details
92 were consented for the study, as some were in screening at the time enrollment closed and to account for dropouts.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55 years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Non-White | 8 Participants |
| Race/Ethnicity, Customized White | 26 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 30 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 30 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 30 | 0 / 31 |
Outcome results
None listed