Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial (IMPEDE)

• ClinicalTrials.gov Identifier: NCT05681559
• Recruitment Status: Recruiting
• First Posted: January 12, 2023
• Last Update Posted: October 12, 2023
• Sponsor: University of Washington
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): David Flum, University of Washington

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diverticulitis	Behavioral: Medi for All; Dietary Supplement: Standard Fiber Supplementation	Not Applicable

Detailed Description:

This is a feasibility-focused, patient-level randomized trial of an intervention promoting the United States Department of Agriculture (USDA) Healthy Med-Style food pattern versus standardized guidance on fiber intake (standard educational materials related to a high-fiber diet) in patients with a history of diverticulitis. This trial will assess and address barriers to the eventual large-scale trial and lay groundwork for that trial that will focus on the risk of recurrent diverticulitis and other clinical outcomes. The investigators will also compare changes in serum and stool biomarkers of inflammation that are proximal endpoints in the causal path relating a Mediterranean diet pattern's anti-inflammatory properties and recurrence of diverticulitis.

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. Every two weeks, participants in the intervention arm will be prompted via a digital online platform (analog also available) to complete the 14-item Mediterranean Diet Assessment Score (MEDAS) (an adapted version of the MEDAS Score previously used in the Prevencion con Dieta Mediterranea [PREDIMED study]) for the purpose of providing timely, individual feedback on diet adherence (not for assessing adherence to the diet pattern). The MEDAS score will be calculated via the online digital platform and ranked according to 3 cutpoints: ≤7, 8-9, or ≥10. Patients will be encouraged to achieve a score of ≥10 which is considered high adherence. The platform will then offer feedback based on the levels of self-reported adherence to the diet including self vs. peer comparisons and support resources. Nudge messages will utilize information from a baseline assessment of participants' dietary attitudes and beliefs about which food groups within a Med-style food pattern they perceive to be most within their control. Ultimately, this approach will enable us to provide participants with dietary information and services that support adherence by accounting for attitudes, norms, and perceived control. The extent of interaction with the online platform will be assessed bi-weekly; degree of adherence to the USDA Med-style food pattern; and engagement in dietician services will be assessed at quarterly intervals.

Participants randomized to the High Fiber Diet Arm will be given commonly used patient education pamphlet, 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Investigation of Medical Management to Prevent Episodes of Diverticulitis (IMPEDE) Trial
• Actual Study Start Date: January 1, 2023
• Estimated Primary Completion Date: April 1, 2025
• Estimated Study Completion Date: April 1, 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Medi for All; 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; Please see description of Medi for All arm
Active Comparator: Fiber Supplementation; 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; Please see description of Fiber Supplementation arm

Outcome Measures

Primary Outcome Measures :

1. Willingness to enroll [ Time Frame: through study completion, over a period of 2 years ]
   Number of randomized participants out of number approached
2. Adherence to Med-Style Food Pattern [ Time Frame: through study completion, over a period of 12 months ]
   Med-style Pattern score calculated from the Nutrition Assessment Shared Resource Food Frequency Questionnaire
3. Participant retention [ Time Frame: through study completion, over a period of 12 months ]
   Proportion enrolled and retained at 3, 6, 9 and 12 months
4. Engagement with nutrition services [ Time Frame: Quarterly through study completion, over a period of 12 months ]
   Number of sessions with dietician
5. Interaction with online program [ Time Frame: Bi-weekly through study completion, over a period of 12 months ]
   Number of times accessed

Secondary Outcome Measures :

1. Change in Plasma, Interleukin (IL)-6, IL-10, IL-1b, fecal calprotectin [ Time Frame: Baseline, 6, 12 months through study completion, over a period of 12 months ]
   Concentration
2. Diverticulitis events [ Time Frame: Quarterly through study completion, over a period of 12 months ]
   Self-reported (presumed), subset of those resulting in healthcare utilization (e.g., hospitalization, surgery).
3. National Surgical Quality Improvement Program (NSQIP)-defined complications, a subset of which are serious adverse events to be reported to Independent Safety Monitor [ Time Frame: Quarterly through study completion, over a period of 12 months ]
   Standardized assessment-serious events defined as death, cardiac arrest, myocardial infarction, pneumonia, progressive renal insufficiency, acute renal failure, pulmonary embolism, deep vein thrombosis, return to operating room, serious site infections
4. Change in Diverticulitis Quality of Life Survey (DVQOL) [ Time Frame: Baseline, 6, 12 months ]
   A 17-item questionnaire that assesses four domains: symptoms, concerns, emotions, and behavior changes related to diverticulitis, ranging from 0 (best) to 10 (worst)
5. Change in Gastrointestinal Quality of Life Index (GIQLI) [ Time Frame: Baseline, 6, 12 months ]
   A 36-item questionnaire that assesses five domains: gastrointestinal symptoms, physical function, emotional well-being, social well-being, and perception of medical treatment measured by a single item question. Each item has 5 response choices (i.e., all of the time, most of the time, some of the time, a little of the time, never). In addition, the measure produces an overall QoL score (0-144) where higher numbers indicate greater QoL.
6. Change in International Physical Activity Questionnaire (IPAQ) short form [ Time Frame: Baseline, 6, 12 months ]
   A validated 7-item questionnaire: moderate and vigorous physical activity, walking, and sitting in the past 7 days. Output is self-reported minutes of moderate and vigorous physical activity as well as walking from which weekly moderate and vigorous physical activity, sitting, and walking can be assessed.
7. Healthcare utilization [ Time Frame: Quarterly through study completion, at 3, 6, 9, 12 months ]
   Counts of ED/hospital encounters, diverticulitis-related diagnostic/therapeutic interventions
8. Change in self-reported weight [ Time Frame: Baseline, 6, 12 months ]
   Self-reported weight

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Contacts and Locations

Contacts

Contact: Sandra Mata-Diaz, MPH; 206-221-3762; sandramd@uw.edu

Contact: Erin Fannon; 206-543-9926; ecarney@uw.edu

Locations

United States, Washington

Harborview Medical Center; Recruiting

Seattle, Washington, United States, 98104

Contact: Lisa Strate, MD, MPH

Sponsors and Collaborators

University of Washington

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: David R Flum, MD, MPH; University of Washington

  Study Documents (Full-Text)

Documents provided by David Flum, University of Washington:

Study Protocol and Statistical Analysis Plan  [PDF] August 7, 2023

More Information

• Responsible Party: David Flum, Professor, School of Medicine, University of Washington
• ClinicalTrials.gov Identifier: NCT05681559
• Other Study ID Numbers: STUDY00015672; 1R01DK131694-01A1 ( U.S. NIH Grant/Contract )
• First Posted: January 12, 2023
• Last Update Posted: October 12, 2023
• Last Verified: October 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diverticulitis; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases