NCT04213729

Diet Intervention for Crohn's Disease Patient

A Holistic Diet Intervention for People With Crohn's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Crohn Disease

Interventions

Type	Name	Description
BEHAVIORAL	Diet Counseling	Standard of care diet counseling provided at clinic visit 1.
OTHER	CD LFD	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.
BEHAVIORAL	Dyadic Psychological Support (DPS)	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.

Timeline

• Start date: 2019-11-26
• Primary completion: 2024-02-20
• Completion: 2024-02-20
• First posted: 2019-12-30
• Last updated: 2024-02-29

Locations

1 site across 1 country: United States