Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Women's College Hospital | OTHER |
| NYU Langone Health | OTHER |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to learn whether changing diet impacts psoriatic arthritis (PsA).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet 1 | Active Comparator | Diet 1 will focus on the dietary pattern and monitor types of foods, supplementary nutrition, and provide nutritional support with a dietitian. |
|
| Diet 2 | Active Comparator | Diet 2 will focus on the dietary pattern and monitor the amount of food, complimentary nutrition, and nutritional support with a dietitian. |
|
| Diet 3 | No Intervention | Diet 3 will focus on healthy dietary patterns and provide nutritional support with a dietitian. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet 1 | Other | Diet 1 will focus on which foods are eaten and the impact on disease outcomes. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity in Psoriatic Arthritis (DAPSA) | 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
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity in Psoriatic Arthritis (DAPSA) | 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
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Alexis Ogdie-Beatty, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Lihi Eder, MD, PhD | Women's College Hospital, University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States | ||
| Women's College Hospital, University of Toronto |
Manuscripts describing research results will be drafted and submitted in a timely manner for publication in widely circulated peer-reviewed journals. Physicians and researchers may request de-identified data from the PI and research plans will be reviewed on a case by case basis.
Not provided
Not provided
Not provided
Not provided
92 were consented for the study, as some were in screening at the time enrollment closed and to account for dropouts.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mediterranean (MED) Diet | Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction |
| FG001 | DASH-LC (Low Calorie) Diet | Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss) |
| FG002 | Standard of Care (Control) | Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mediterranean (MED) Diet | Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction |
| BG001 | DASH-LC (Low Calorie) Diet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Disease Activity in Psoriatic Arthritis (DAPSA) | 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
| Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
Adverse events were collected from the time of informed consent to the time of completion of the final study visit (approx. 6 months)
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries should be regarded as adverse events. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, important medical events, cardiovascular events, pulmonary events, or hospitalizations.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mediterranean (MED) Diet | Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Gillespie, MS | University of Pennsylvania | 2156141840 | sarah.hopkins@pennmedicine.upenn.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 12, 2023 | Nov 21, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| C563250 | Salivary Gland Adenoma, Pleomorphic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
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.
Not provided
Not provided
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.
| Diet 2 |
| Other |
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). |
|
| 24 weeks |
| Patient Reported Outcomes-Psoriatic Arthritis Disease Impact | -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. | Varying times: (at Baseline) 0, 12, 24 Weeks |
| Patient Reported Outcomes-Fatigue | -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. | Varying times: (at Baseline) 0, 12, 24 Weeks |
| Metabolic Profile-Weight | 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 | Varying times: (at Baseline) 0, 12, 24 Weeks |
| Metabolic Profile-Waist Measurement | Waist measurement_cm | Varying times: (at Baseline) 0, 12, 24 Weeks |
| Toronto |
| Ontario |
| Canada |
Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss) |
| BG002 | Standard of Care (Control) | Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Primary goal was to promote healthy dietary pattern following MED dietary principle: abundant use of olive oil and nuts (food delivery), as well as fruits, vegetables, fish, legumes No calorie restriction |
| OG001 | DASH-LC (Low Calorie) Diet | Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss) |
| OG002 | Standard of Care (Control) | Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician) |
|
|
| Secondary | Change in Disease Activity in Psoriatic Arthritis (DAPSA) | 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
| Posted | Mean | 95% Confidence Interval | score on a scale | 24 weeks |
|
|
|
| Secondary | Patient Reported Outcomes-Psoriatic Arthritis Disease Impact | -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. | Posted | Mean | 95% Confidence Interval | score on a scale | Varying times: (at Baseline) 0, 12, 24 Weeks |
|
|
|
| Secondary | Patient Reported Outcomes-Fatigue | -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. | Posted | Mean | 95% Confidence Interval | t score | Varying times: (at Baseline) 0, 12, 24 Weeks |
|
|
|
| Secondary | Metabolic Profile-Weight | 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 | Posted | Mean | 95% Confidence Interval | kg | Varying times: (at Baseline) 0, 12, 24 Weeks |
|
|
|
| Secondary | Metabolic Profile-Waist Measurement | Waist measurement_cm | Posted | Mean | 95% Confidence Interval | cm | Varying times: (at Baseline) 0, 12, 24 Weeks |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | DASH-LC (Low Calorie) Diet | Primary goal was to lose weight following a low calorie, low fat Dietary Approaches to Stop Hypertension (DASH) diet Calories limited to 1200-1600 a day (based on age, sex, BMI and goal for weight loss) | 0 | 30 | 0 | 30 | 0 | 30 |
| EG002 | Standard of Care (Control) | Non-personalized dietary advice about healthy diet principles (10 minutes meeting with a dietician) | 0 | 31 | 0 | 31 | 0 | 31 |
Not provided
Not provided
Not provided
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
|
|
|