Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial

NCT05681559 | Active Not Recruiting

• 2 other identifiers: STUDY000156721R01DK131694-01A1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized trial (n=75) of a Mediterranean style Food Pattern and versus standardized guidance on fiber intake for patients with diverticulitis to evaluate the feasibility of this dietary intervention including willingness to randomize and adherence to a Med-style dietary pattern. The investigators will employ state-of-the-art behavioral interventions in the form of electronic feedback to improve health-related behaviors and support dietary customization based on participants' budget, dietary preferences, and restrictions. The investigators will also examine plasma inflammatory biomarkers (interleukin-6, interleukin-10, and interleukin-1β) and fecal calprotectin at baseline, 6, and 12 months.

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (5)

• Willingness to enroll

  Number of randomized participants out of number approached

  through study completion, over a period of 2 years

• Adherence to Med-Style Food Pattern

  Med-style Pattern score calculated from the Nutrition Assessment Shared Resource Food Frequency Questionnaire

  through study completion, over a period of 12 months

• Participant retention

  Proportion enrolled and retained at 3, 6, 9 and 12 months

  through study completion, over a period of 12 months

• Engagement with nutrition services

  Number of sessions with dietician

  Quarterly through study completion, over a period of 12 months

• Interaction with online program

  Number of times accessed

  Bi-weekly through study completion, over a period of 12 months

Secondary Outcomes (8)

• Change in Plasma, Interleukin (IL)-6, IL-10, IL-1b, fecal calprotectin

  Baseline, 6, 12 months through study completion, over a period of 12 months

• Diverticulitis events

  Quarterly through study completion, over a period of 12 months

• National Surgical Quality Improvement Program (NSQIP)-defined complications, a subset of which are serious adverse events to be reported to Independent Safety Monitor

  Quarterly through study completion, over a period of 12 months

• Change in Diverticulitis Quality of Life Survey (DVQOL)

  Baseline, 6, 12 months

• Change in Gastrointestinal Quality of Life Index (GIQLI)

  Baseline, 6, 12 months

Study Arms (2)

Medi for All

ACTIVE COMPARATOR

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.

Behavioral: Medi for All

Fiber Supplementation

ACTIVE COMPARATOR

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.

Dietary Supplement: Standard Fiber Supplementation

Interventions

Medi for All BEHAVIORAL

Please see description of Medi for All arm

Medi for All

Standard Fiber Supplementation DIETARY_SUPPLEMENT

Please see description of Fiber Supplementation arm

Fiber Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult ≥18 years;
• Patients presenting (or recently presented) to gastroenterologist or surgeons or accessing study website after recovery from an episode of diverticulitis (within the prior 18 months), either the index episode or recurrent.
• Ability to provide written informed consent in English.

You may not qualify if:

• Unable or unwilling to return for specimen collection visits or be contacted for and/or complete research surveys;
• Currently incarcerated in a detention facility or in police custody (patients wearing a monitoring device can be enrolled) at baseline/screening;
• Last episode of acute diverticulitis currently unresolved (i.e., on antibiotics for diverticulitis; drain in place);
• Intolerance/allergy to the main components of the Med-style food pattern;
• Surgery for diverticulitis within past 6 months without an episode of diverticulitis post-surgery;
• Planned elective surgery in next 6 months

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Diverticulitis

Interventions

Proto-Oncogene Proteins c-raf

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

raf Kinases; MAP Kinase Kinase Kinases; Protein Serine-Threonine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Amino Acids, Peptides, and Proteins; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins

Study Officials

• David R Flum, MD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Medicine

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: January 12, 2023
• Study Start: January 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 28, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Locations

US (1)