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Mediterranean Dietary Intervention for HS

ConditionHidradenitis Suppurativa
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Mediterranean Diet Counseling

    Behavioral

    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 Support

    Other intervention

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Med-South Lifestyle Program (MSLP)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

1

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
2

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.

Time frame
Week 16

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Hidradenitis Suppurativa Foundation

Collaborator

Source ClinicalTrials.gov

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