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| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
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The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of life and signs of inflammation in blood and stool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohn's Disease (CD) Control Group | Active Comparator | Participants will receive only the one time standard of care in-clinic diet counseling at visit 1. |
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| Experimental CD Low Fat Diet (LFD) Group | Experimental | Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. |
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| Experimental CD LFD + DPS Group | Experimental | Participants and one family member that lives with them will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks. In addition, the participant and their family member will receive 12 consecutive weeks of Dyadic Psychological Support (DPS). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Counseling | Behavioral | Standard of care diet counseling provided at clinic visit 1. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in fat intake | Change in daily fat intake calculated through patient reported diet diary app Nutrihand. | Baseline, 8 weeks |
| Rate of adherence to fat intake | Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24). | Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2). | PRO2 is the sum of the average daily stool frequency and abdominal pain. A weighted total PRO2 score of less than 75 is an indication of remission. | Baseline, Week 8 |
| Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI) |
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Inclusion Criteria for Crohn's disease:
Exclusion Criteria for Crohn's disease:
Patients with Ulcerative Colitis and Celiac Disease
Inclusion and Exclusion Criteria for Family-like Member
Inclusion:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Maria T Abreu, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| CD LFD | Other | Daily breakfast, lunch, dinner and snacks LFD catered meals. Meals will have approximately 20% calories from fat, a goal ratio close to 1:1 omega-6/omega-3 fatty acids, and approximately 25-35 grams of fiber per day. |
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| Dyadic Psychological Support (DPS) | Behavioral | The dyadic psychosocial support (DPS) intervention will be provided for a total of 12 weeks. The 12-week DPS intervention consists of eight sessions (main sessions) and two booster sessions. The intervention will incorporate psychoeducational components that combine didactic and behavioral regulatory procedures to promote healthy diet behavior for self-determined reasons. |
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HBI is a 5-item questionnaire. An HBI score of <5 indicates remission, 5-7 indicates mild disease, 8-16 indicates moderate disease and >16 indicates severe disease. |
| Baseline, Week 8 |
| Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI). | sCDAI is the sum of the average daily stool frequency, general well-being and abdominal pain. A weighted total sCDAI score of less than 150 indicates remission, 150-219 indicates mild activity, 220-450 indicates moderate activity and > 450 indicates severe activity. | Baseline, Week 8 |
| Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ). | sIBDQ is a 10-item shortened version of the original IBDQ assessing QOL with total scores ranging from 1 to 7 with a higher score indicating a better QOL. | Baseline, Week 8 |
| Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29). | The PROMIS-29, a generic health-related quality of life survey, assesses each of the 7 PROMIS domains with 4 questions. The questions are ranked on a 5-point Likert Scale. There is also one 11-point rating scale for pain intensity. A score of 50 represents the mean or average of the reference population. A score of 60 means that the person is one standard deviation above the reference population (standard deviation = 10). | Baseline, Week 8 |
| Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP). | Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluated in mg/L. | Baseline, Week 8 |
| Change in the expression of Serum Amyloid A (SAA). | Change in the expression of SAA evaluated in pg/mL. | Baseline, Week 8 |