Diet Intervention for Crohn's Disease Patient

Not Applicable

Completed

• Conditions: Crohn Disease
• Interventions: Other: CD LFD; Behavioral: Diet Counseling; Behavioral: Dyadic Psychological Support (DPS)

• Registration Number: NCT04213729
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-26
• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2019-12-24
• Study First Posted: 2019-12-30
• Status Verified: 2024-02
• Primary Completion: 2024-02-20
• Study Completion: 2024-02-20
• Last Update Submitted: 2024-02-28
• Last Update Posted: 2024-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental CD Low Fat Diet (LFD) Group	CD LFD	Participants will be provided catered LFD meals for 8 consecutive weeks consisting of daily breakfast, lunch, dinner and snacks.
Crohn's Disease (CD) Control Group	Diet Counseling	Participants will receive only the one time standard of care in-clinic diet counseling at visit 1.
Experimental CD LFD + DPS Group	CD LFD	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).
Experimental CD LFD + DPS Group	Dyadic Psychological Support (DPS)	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).

Primary Outcome Measures

Name	Time	Method
Rate of adherence to fat intake	Week 36	Adherence to fat intake is measured by the web-based Automated Self-Administered 24-hour diet recall (ASA24).
Change in fat intake	Baseline, 8 weeks	Change in daily fat intake calculated through patient reported diet diary app Nutrihand.

Secondary Outcome Measures

Name	Time	Method
Change in clinical symptoms as assessed by Patient Reported Outcomes (PRO2).	Baseline, Week 8	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.
Change in quality of life (QoL) as assessed by the Short Inflammation Bowel Disease Questionnaire (sIBDQ).	Baseline, Week 8	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.
Change in clinical symptoms as assessed by the Short Crohn's Disease Activity Index (sCDAI).	Baseline, Week 8	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.
Change in clinical symptoms as assessed by the Harvey Bradshaw Index (HBI)	Baseline, Week 8	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.
Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP).	Baseline, Week 8	Change in the expression of cytokine high-sensitivity C-reactive protein (hsCRP) evaluated in mg/L.
Change in quality of life (QoL) as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS-29).	Baseline, Week 8	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).
Change in the expression of Serum Amyloid A (SAA).	Baseline, Week 8	Change in the expression of SAA evaluated in pg/mL.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States