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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
300
Standard of care diet counseling provided at clinic visit 1.
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.
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.
University of Miami
Miami, Florida, United States
Change in fat intake
Change in daily fat intake calculated through patient reported diet diary app Nutrihand.
Time frame: 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).
Time frame: Week 36
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.
Time frame: Baseline, Week 8
Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 8
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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).
Time frame: 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.
Time frame: Baseline, Week 8
Change in the expression of Serum Amyloid A (SAA).
Change in the expression of SAA evaluated in pg/mL.
Time frame: Baseline, Week 8