Pilot Feasibility Study of a Mediterranean Diet Intervention for Hidradenitis Suppurativa
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of Intervention Measure (FIM)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Med-South Lifestyle Program (MSLP)
Participants receive a 16-week Mediterranean-pattern dietary intervention consisting of individualized dietary counseling, a cooking education module, Mediterranean food support, and printed educational materials. Participants complete in-person study visits at baseline (Week 0) and Week 16, scheduled in conjunction with routine dermatology appointments when possible.
干预措施: Mediterranean Diet Counseling (Behavioral)
Med-South Lifestyle Program (MSLP)
Participants receive a 16-week Mediterranean-pattern dietary intervention consisting of individualized dietary counseling, a cooking education module, Mediterranean food support, and printed educational materials. Participants complete in-person study visits at baseline (Week 0) and Week 16, scheduled in conjunction with routine dermatology appointments when possible.
干预措施: Mediterranean Food Support (Other)
结局指标
主要结局
Feasibility of Intervention Measure (FIM)
时间窗: Week 16
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.
次要结局
- Change in Mediterranean Diet Adherence Screener (MEDAS) Score(Week 0 and Week 16)
- Acceptability of Intervention Measure (AIM)(Week 16)