An interventional study of Medi for All and Standard Fiber Supplementation in Diverticulitis, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
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.
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.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 71 is below the median of 120 across 63 interventional studies indexed under Diverticulitis.
Browse Diverticulitis studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 Medi for All arm
Please see description of Fiber Supplementation arm
Willingness to enroll
Number of randomized participants out of number approached
Time frame: 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
Time frame: through study completion, over a period of 12 months
Participant retention
Proportion enrolled and retained at 3, 6, 9 and 12 months
Time frame: through study completion, over a period of 12 months
Engagement with nutrition services
Number of sessions with dietician
Time frame: Quarterly through study completion, over a period of 12 months
Interaction with online program
Number of times accessed
Time frame: Bi-weekly through study completion, over a period of 12 months
Change in Plasma, Interleukin (IL)-6, IL-10, IL-1b, fecal calprotectin
Concentration
Time frame: 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).
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
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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 6, 12 months
Healthcare utilization
Counts of ED/hospital encounters, diverticulitis-related diagnostic/therapeutic interventions
Time frame: Quarterly through study completion, at 3, 6, 9, 12 months
Change in self-reported weight
Self-reported weight
Time frame: Baseline, 6, 12 months
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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