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NCT07168499 · ClinicalTrials.gov registry record · NA
Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis
A NA study of IBD (Inflammatory Bowel Disease), sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT07168499 is a NA study of IBD (Inflammatory Bowel Disease) that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 160 participants, above the 103-participant average among 3 other IBD (Inflammatory Bowel Disease) trials with a reported enrollment target (55% higher). The trial reports 1 study location across 1 state.
The verdict
NCT07168499, a NA study of IBD (Inflammatory Bowel Disease), is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study Summary
Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfulness/stress management + nutrition support) with advanced therapies for induction and maintenance of clinical remission in CD and UC as evaluated by disease activity scores in patients with active CD and UC. Researchers will compare 4 study arms (Group 1, Group 2, Group 3, and Group 4) to see if combining lifestyle modifications with advanced therapies for induction and maintenance will show improvement in condition as evaluated by disease activity scores. Groups: 1. Group A - Subjects will receive a visit with an IBD dietician and a visit with an IBD GI psychologist within the first month of advanced therapy initiation and another visit with both parties 4+/-2 weeks after the first intervention visit. 2. Group B - Subjects will receive a visit with an IBD dietician within the first month of advanced therapy initiation and another visit 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD GI psychologist after 3 months (after assessment of our primary outcomes). 3. Group C - Subjects will receive a visit with an IBD psychologist within the first month of advanced therapy initiation and another visit with the IBD GI psychologist 4+/-2 weeks after the first intervention visit. They will later be offered a visit with an IBD dietician after 2 months (after assessment of our primary outcomes). 4. Group D - Subjects will be offered a visit with an IBD GI psychologist and IBD dietician after 3 months (after assessment of our primary outcomes). All subjects will be asked to complete a set of questionnaires and have the option to give blood and stool samples throughout the life of their participation in the study at certain visits.
Conditions Studied
Interventions
- BEHAVIORAL Stress Management
- BEHAVIORAL Diet Management
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-09-15 |
| Est. Completion | 2028-05-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07168499
The ClinicalTrials.gov registry entry for NCT07168499 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 103-participant average among 3 other IBD (Inflammatory Bowel Disease) trials with a reported enrollment target (55% higher). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with IBD (Inflammatory Bowel Disease) appearing as the primary indexed condition, and to 2 interventions - of which Stress Management is the first listed.
NCT07168499 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT07168499 about?
NCT07168499 is a clinical study titled "Diet and Stress Management Combined With Advanced Therapy for Crohn's and Ulcerative Colitis". Inflammatory Bowel Disease (IBD), which includes Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, immune-mediated disease characterized by recurrent episodes of relapse. The goal of this single site, pragmatic, randomized trial is to answer if combining lifestyle modifications (mindfu...
What is the current status of trial NCT07168499?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2025-09-15. Estimated completion is 2028-05-01.
What conditions does trial NCT07168499 study?
This clinical trial studies the following conditions: IBD (Inflammatory Bowel Disease).
What interventions are being tested in trial NCT07168499?
The interventions under investigation include: Stress Management (BEHAVIORAL), Diet Management (BEHAVIORAL).
Who is sponsoring clinical trial NCT07168499?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07168499 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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