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Behavioral Intervention

Mediterranean Diet for Diverticulitis (IMPEDE Trial)

N/A
Recruiting
Led By David R Flum, MD, MPH
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥18 years
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, over a period of 2 years
Awards & highlights

IMPEDE Trial Summary

This trial studies a Mediterranean diet versus standard dietary advice for patients with diverticulitis. It will use electronic feedback to customize diets, with biomarker and fecal tests to measure impact.

Who is the study for?
This trial is for adults over 18 who have had an episode of diverticulitis in the last 18 months and can consent in English. It's not for those with allergies to Mediterranean diet foods, unable or unwilling to follow-up, currently on treatment for unresolved diverticulitis, or incarcerated.Check my eligibility
What is being tested?
The study compares a Mediterranean-style diet (Medi) with standard fiber supplements in managing diverticulitis. Participants will be randomly assigned to one of the diets and receive electronic feedback to support dietary adherence. Inflammatory markers will be tracked over a year.See study design
What are the potential side effects?
Since this trial involves dietary interventions, side effects may include gastrointestinal discomfort due to changes in diet. However, specific side effects are not detailed as they depend on individual tolerance to the Med-style food pattern or fiber supplementation.

IMPEDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

IMPEDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, over a period of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, over a period of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence to Med-Style Food Pattern
Engagement with nutrition services
Interaction with online program
+2 more
Secondary outcome measures
Change in Diverticulitis Quality of Life Survey (DVQOL)
Change in Gastrointestinal Quality of Life Index (GIQLI)
Change in International Physical Activity Questionnaire (IPAQ) short form
+5 more

IMPEDE Trial Design

2Treatment groups
Active Control
Group I: Fiber SupplementationActive Control1 Intervention
Participants randomized to the High Fiber Diet Arm will be given commonly used patient education pamphlet,149 describing fiber and high-fiber foods, the rationale for increasing fiber intake, and ways patients can promote greater intake. Based on prior observational studies of incident diverticulitis, at least 25 grams/day of fiber will be recommended for participants.
Group II: Medi for AllActive Control1 Intervention
Participants randomized to the USDA Mediterranean-style Food Pattern Arm (called Medi for all) will have access to a "toolbox" that includes education materials (e.g., food pattern tables according to daily caloric intake), recipes, grocery lists, group-based online dietary support, feedback, and reminders to encourage dietary change. Recipes and grocery lists can be individualized to a participant's food budget and preferences. Materials will be available in print and Web-based. This state-of-the art intervention will then use electronic feedback in the form of nudge messages designed to motivate participants to sustain or improve adherence to the Med-style Food Pattern.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,738 Previous Clinical Trials
1,844,276 Total Patients Enrolled
2 Trials studying Diverticulitis
748 Patients Enrolled for Diverticulitis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,357 Previous Clinical Trials
4,315,111 Total Patients Enrolled
1 Trials studying Diverticulitis
418 Patients Enrolled for Diverticulitis
David R Flum, MD, MPHPrincipal InvestigatorUniversity of Washington
7 Previous Clinical Trials
2,033 Total Patients Enrolled

Media Library

Medi for All (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05681559 — N/A
Diverticulitis Research Study Groups: Fiber Supplementation, Medi for All
Diverticulitis Clinical Trial 2023: Medi for All Highlights & Side Effects. Trial Name: NCT05681559 — N/A
Medi for All (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681559 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for participation left in this clinical trial?

"This clinical study, which was posted to clinicaltrials.gov on January 1st 2023 is currently enrolling patients; the trial has been updated as recently as February 17th 2023."

Answered by AI

How many individuals are being considered for inclusion in this research?

"Affirmative, the clinicaltrials.gov site shows that this medical investigation is still accepting study participants. It was initially advertised on January 1st 2023 and its details have been revised most recently on 17th February of the same year. 75 patients need to be sourced from one centre for this trial."

Answered by AI

What is the intended outcome of this research?

"This 12-month clinical trial will evaluate patient willingness to enroll by assessing their biweekly progress. Secondary endpoints include changes in self-reported weight, National Surgical Quality Improvement Program (NSQIP)-defined complications reported to an Independent Safety Monitor, and Diverticulitis Quality of Life Survey (DVQOL) scores ranging from 0 (best) to 10 (worst)."

Answered by AI

Who else is applying?

What site did they apply to?
Harborview Medical Center
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I haven't tried treating my diverticulitis, so maybe it's time.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial
David Flum 2023. "Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05681559.
All > Diverticulitis
~31 spots leftby Apr 2025
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