DiverticulitisIMPEDENCT05681559
Investigation of Medical Management to Prevent Episodes of Diverticulitis Trial
A study testing Medi for All and Standard Fiber Supplementation in people with Diverticulitis, run by University of Washington at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticulitis
- What is being tested?
- Medi for All and Standard Fiber Supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2023to 17 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Investigation of Medical Management to Prevent Episodes of Diverticulitis (IMPEDE) Trial
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.
Read the 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.
- Conditions
- Diverticulitis
- Being tested
- Medi for All, Standard Fiber Supplementation
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medi for AllBehavioural
Please see description of Medi for All arm
Standard Fiber SupplementationDietary supplement
Please see description of Fiber Supplementation arm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Standard Fiber Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to enroll
Number of randomized participants out of number approached
Measured: 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
Measured: through study completion, over a period of 12 months
Participant retention
Proportion enrolled and retained at 3, 6, 9 and 12 months
Measured: through study completion, over a period of 12 months
Engagement with nutrition services
Number of sessions with dietician
Measured: Quarterly through study completion, over a period of 12 months
Interaction with online program
Number of times accessed
Measured: 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
Concentration
Measured: Baseline, 6, 12 months through study completion, over a period of 12 months
Diverticulitis events
Self-reported (presumed), subset of those resulting in healthcare utilization (e.g., hospitalization, surgery).
Measured: 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
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
Measured: Quarterly through study completion, over a period of 12 months
Change in Diverticulitis Quality of Life Survey (DVQOL)
A 17-item questionnaire that assesses four domains: symptoms, concerns, emotions, and behavior changes related to diverticulitis, ranging from 0 (best) to 10 (worst)
Measured: Baseline, 6, 12 months
Change in Gastrointestinal Quality of Life Index (GIQLI)
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.
Measured: Baseline, 6, 12 months
Change in International Physical Activity Questionnaire (IPAQ) short form
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.
Measured: Baseline, 6, 12 months
Healthcare utilization
Counts of ED/hospital encounters, diverticulitis-related diagnostic/therapeutic interventions
Measured: Quarterly through study completion, at 3, 6, 9, 12 months
Change in self-reported weight
Self-reported weight
Measured: Baseline, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Jan 2023
- Primary completion16 Jan 2026
- Study completion17 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiverticulitisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Flum, University of Washington
- Investigators
- David R Flum, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681559
- Sponsor's protocol ID
- STUDY00015672
- Other IDs
- 1R01DK131694-01A1
- Acronym
- IMPEDE
- Status last verified
- Jun 2026
- First submitted
- 23 Nov 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Medical Management to Prevent Episodes of Diverticulitis (IMPEDE) Trial
- ClinicalTrials.gov ID
- NCT05681559
- Acronym / sponsor ID
- IMPEDE / STUDY00015672
- Conditions
- Diverticulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 16 Jan 2026 (actual)
- Study completion
- 17 Feb 2026 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medi for All | Active comparator | Behavioral: Medi for AllParticipants 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. |
| Fiber Supplementation | Active comparator | Dietary Supplement: Standard Fiber SupplementationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medi for AllPlease see description of Medi for All arm | Behavioural | Medi for All |
| Standard Fiber SupplementationPlease see description of Fiber Supplementation arm | Dietary supplement | Fiber Supplementation |
Primary outcome
Willingness to enroll
Time frame: through study completion, over a period of 2 years
Number of randomized participants out of number approached
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
Participant retention
Time frame: through study completion, over a period of 12 months
Proportion enrolled and retained at 3, 6, 9 and 12 months
Engagement with nutrition services
Time frame: Quarterly through study completion, over a period of 12 months
Number of sessions with dietician
Interaction with online program
Time frame: Bi-weekly through study completion, over a period of 12 months
Number of times accessed
8 secondary outcomes
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
Diverticulitis events
Time frame: 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
Time frame: Quarterly through study completion, over a period of 12 months
Change in Diverticulitis Quality of Life Survey (DVQOL)
Time frame: Baseline, 6, 12 months
Change in Gastrointestinal Quality of Life Index (GIQLI)
Time frame: Baseline, 6, 12 months
Change in International Physical Activity Questionnaire (IPAQ) short form
Time frame: Baseline, 6, 12 months
Healthcare utilization
Time frame: Quarterly through study completion, at 3, 6, 9, 12 months
Change in self-reported weight
Time frame: Baseline, 6, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Flum, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medi for All and Standard Fiber Supplementation in people with Diverticulitis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Willingness to enroll (time frame: through study completion, over a period of 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.