Mediterranean Dietary Intervention for HS

N/ANot Yet RecruitingNCT07800416

University of North Carolina, Chapel Hill30 enrolled

Overview

The goal of this clinical trial is to learn whether a 16-week Mediterranean-style dietary counseling program, called the Med-South Lifestyle Program (MSLP), is practical and acceptable for adults with hidradenitis suppurativa (HS). The study will also look at whether participants' Mediterranean diet adherence changes during the program. The main questions it aims to answer are: * Do participants find the program feasible and practical to follow? * Does adherence to a Mediterranean-style diet change from the beginning to the end of the 16-week program? * Do participants find the program acceptable? All participants will receive the same program; there is no comparison group. Participants will: * Take part in individual nutrition counseling and shorter support calls, mostly by video or telephone * Complete a cooking education session and receive written nutrition materials * Receive Mediterranean-style food support, including pantry staples and prepared meals * Attend two in-person study visits, at the beginning and end of the 16-week program * Complete questionnaires and study assessments and provide biological samples Because this is a pilot study, the information collected will primarily be used to improve the program and help plan a larger future clinical trial.

This study involves a 16-week Mediterranean-style eating program for people with hidradenitis suppurativa (HS). The program is called the Med-South Lifestyle Program (MSLP) and is designed to support practical, realistic dietary changes. Most study activities are completed remotely. Participants will have two in-person visits, at the beginning and end of the study, usually scheduled after a regular dermatology appointment to avoid an extra clinic trip. Participants will receive one-on-one nutrition counseling by video call from dietetic students supervised by a registered dietitian. Counseling sessions occur throughout the 16 weeks and include nutrition education, goal setting, and practical strategies for following a Mediterranean-style diet. Participants will also complete a cooking education session and receive written program materials. Participants will receive some food support, including Mediterranean pantry staples such as olive oil, herbs, and spices, as well as prepared meals delivered during the study. Food allergies, intolerances, and dietary restrictions will be reviewed before food is provided. Participants will complete brief questionnaires during the study and additional study activities at the beginning and end. These visits may include health measurements and collection of blood, urine, saliva, stool, and skin swab samples. At the end of the study, participants will also have an opportunity to provide feedback about their experience with the program.

Interventions

Mediterranean Diet CounselingBEHAVIORAL

Participants receive a 16-week Mediterranean-pattern dietary counseling program delivered primarily by video call. Individual counseling is provided by dietetic students under the supervision of a registered dietitian. Six core sessions occur at Weeks 1, 2, 5, 8, 11, and 14, with five individualized adherence-support contacts at Weeks 3, 6, 9, 12, and 15. Core sessions cover vegetables and fruit; whole grains and legumes; nuts, oils, dressings, and spreads; beverages, desserts, and snacks; eating out and sodium; and fish, meat, poultry, dairy, and eggs. Sessions include progress review, nutrition education, collaborative goal setting, an action plan, and planning for the next contact. A group or recorded cooking education module is completed between Weeks 5 and 8. Printed materials include HS and nutrition summaries, the MSLP manual, and cookbook.

Mediterranean Food SupportOTHER

Participants receive Mediterranean-pattern food support during the 16-week intervention to facilitate implementation of the dietary recommendations. At the baseline study visit, participants receive selected Mediterranean pantry staples, including extra-virgin olive oil, herbs, and spices. Home-delivered prepared meals consistent with the intervention dietary pattern are also provided during the study period. Before food is provided, participants complete an allergy and food-intolerance screening. Dietary restrictions and preferences relevant to food provision are reviewed before subsequent deliveries. Receipt of pantry items and meal deliveries is documented, and participants are asked to report the amount of each delivered meal consumed.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 years or older * Diagnosis of hidradenitis suppurativa confirmed by a board-certified dermatologist * Hurley stage I, II, or III * Baseline abscess and inflammatory nodule (AN) count of at least 3, so that disease activity is measurable in every enrolled participant * Reliable access to Zoom by laptop, tablet, or smartphone * Able to provide written informed consent in English Exclusion Criteria: * Systemic antibiotic use (oral, intramuscular, or intravenous) within 28 days before the planned enrollment visit * Topical antibiotic use within 5 days before the planned enrollment visit * Background HS therapy that has not been stable for the 28 days before enrollment, or that is not expected to remain stable through the 16-week study period * Currently pregnant or breastfeeding * Unable to complete study procedures in English

Outcomes

Primary Outcomes

Feasibility of Intervention Measure (FIM)

The Feasibility of Intervention Measure (FIM) is a four-item participant-reported measure of the perceived feasibility of the intervention. Each item is rated on a five-point Likert scale from 1 (completely disagree) to 5 (completely agree), and the four item scores are averaged to give a total score ranging from 1 to 5. Higher scores indicate greater perceived feasibility. Scores will be summarized among participants with available Week 16 responses.The number of participants contributing data will be reported, and missing Week 16 assessments will be reported as missing rather than treated as study exclusions.

Time frame: Week 16

Secondary Outcomes

Change in Mediterranean Diet Adherence Screener (MEDAS) Score

The Mediterranean Diet Adherence Screener (MEDAS) is a validated 14-item screener developed in the PREDIMED study. Twelve items address the frequency of consumption of specified foods and two address food consumption habits. Each item scores 1 when the Mediterranean-pattern criterion is met and 0 when it is not, resulting in a total score ranging from 0 to 14, with higher scores indicating greater adherence to the Mediterranean dietary pattern. The alcohol item is scored according to the original PREDIMED criterion; increasing alcohol intake is not a goal of the intervention, and a prespecified sensitivity analysis will repeat this outcome using the 13-item score with the alcohol item omitted. The outcome is calculated as the Week 16 MEDAS total score minus the Week 0 MEDAS total score and can range from -14 to +14; positive values indicate increased adherence, negative values indicate decreased adherence, and 0 indicates no change.

Time frame: Week 0 and Week 16

Acceptability of Intervention Measure (AIM)

The Acceptability of Intervention Measure (AIM) is a four-item participant-reported measure of the acceptability of the intervention. Each item is rated on a five-point Likert scale from 1 (completely disagree) to 5 (completely agree), and the four item scores are averaged to give a total score ranging from 1 to 5. Higher scores indicate greater acceptability. Scores will be summarized among participants with available Week 16 responses. The number of participants contributing data will be reported, and missing Week 16 assessments will be reported as missing rather than treated as study exclusions.