Diet Intervention for Crohn's Disease Patient

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

November 26, 2019

Primary Completion Date

February 20, 2024

Study Completion Date

February 20, 2024

Conditions
Crohn Disease
Interventions
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.

Trial Locations (1)

33136

University of Miami, Miami

All Listed Sponsors
collaborator

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

lead

University of Miami

OTHER

NCT04213729 - Diet Intervention for Crohn's Disease Patient | Biotech Hunter | Biotech Hunter