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Набор по приглашению NCT07373275

Adolescent Lifestyle Medicine Headache Study

Без фазы С лечением Headache, Migraine

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Lifestyle Medicine Group Medical Visits.
Кому может быть актуально
Состояния в реестре: Headache, Migraine. Базовые параметры: 14 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Investigating Lifestyle Medicine Interventions for Adolescent Headache Relief

Обзор

The goal of this pilot clinical trial is to assess the implementation of a 7-week Lifestyle Medicine intervention for adolescents with headache. The main question it aims to answer is: Is it feasible to implement a Lifestyle Medicine curriculum for adolescents with headache and secondarily, does this intervention show any signal for improving headache symptoms? Participants will be divided into two groups based on the order of their enrollment. After consent, they will be asked to complete 3 symptom surveys: PedMIDAS-6w, PHQ-A and GAD-7, in addition to a Lifestyle Survey. They will attend group medicine visits virtually, facilitated by the study team. Each week will address a different tenant of Lifestyle Medicine (such as eating or sleep) and participants will create a SMART goal to work on for the week. At the end of the seven weeks, they will repeat these symptom and lifestyle surveys. During the seven weeks, they will also keep a daily symptom diary, which will be texted to their phones through a HIPPA-compliant RedCAP database.

Подробное описание

Lifestyle Medicine is a medical specialty that emphasizes the use of group medical visits to teach and reinforce intensive, evidence-based lifestyle interventions to prevent, treat, and reverse chronic conditions such as headache. Lifestyle Medicine is built on six key pillars: restorative sleep, healthy eating, stress management, physical activity, avoiding risky substances, and positive social connection. Lifestyle modifications, including improved sleep, diet, and exercise are increasingly recommended as first-line approaches for the treatment and prevention of pediatric headache. However, these modifications are often difficult to implement consistently in adolescents due to the lack of structured, developmentally tailored programs that guide behavior change and provide ongoing support.

Study Intervention: Each group will participate in a Zoom meeting with 2-3 members of the research team for 60 minutes once a week for a 7-week program. The first week will be an introduction to the Lifestyle Medicine intervention, a conversation about confidentiality and ground rules for participation in group medical visits. Parents/guardians will be invited to participate in the introduction week if they wish. Participants will be sent a daily link to allow them to complete a headache diary to keep for the duration of the 7-week intervention. In weeks 2 through 7, the sessions will each be focused on one of the 6 lifestyle medicine pillars (restorative sleep, healthy eating, stress management, physical activity, avoiding risky substances, and positive social connection). The sessions will consist of a short presentation about the pillar and the importance of the pillar in reducing symptoms of headache. This presentation will be followed by a group discussion about how aspects of that pillar relate to the participant's experience of headache. For example, during the conversation about sleep, participants could be asked to reflect on their own sleep habits (e.g. what time they go to bed, do they fall asleep right away, is there a TV or phone in their room, do they get woken by text messages, how does fragmented sleep affect them the following day with particular emphasis on headache symptoms). At the end of each visit, each participant will make a Lifestyle Medicine SMART goal pertaining to that week's pillar. A SMART goal is a well-defined objective that is Specific, Measurable, Achievable, Realistic and Time-bound. This goal setting will be done in small breakout groups with study team members; during the session about substance use, goal setting will be done one-on-one. Participants will be asked to collect data during the following week on how successful they were in achieving their SMART goal. They will also be asked to keep a record of their headache symptoms in the headache diary. Study team members will record the goal setting in the electronic medical record (EPIC) and keep study notes about the sessions weekly through RedCAP, which include a feasibility checklist as well as narrative data re: the Proctor Model (Acceptability, Appropriateness, Costs, Feasibility, Fidelity, Penetration, Sustainability).

Вмешательства

  • Поведенческое Lifestyle Medicine Group Medical Visits
    Participants will attend a virtual, one-hour weekly lifestyle medicine group session with their peers for 7 weeks. Each session will address one pillar of Lifestyle Medicine: restorative sleep, healthy eating, stress management, physical activity, avoiding risky substances, and positive social connection. During each session, study team members will provide a short presentation of key components of that lifestyle intervention and meet with participants in small groups to discuss goals related to

Первичные конечные точки

  • Attendance [Срок оценки: From enrollment to end of treatment at 3 months]
  • Headache Diary Completion [Срок оценки: From enrollment to end of treatment at 3 months]
Вторичные конечные точки (4)
  • Positive Lifestyle Changes [Срок оценки: From enrollment to end of treatment at three months]
  • Headache Symptoms [Срок оценки: From enrollment through 3 months.]
  • Headache Severity [Срок оценки: From enrollment through 3 months.]
  • Headache Symptom Reduction [Срок оценки: From enrollment through 3 months.]

Критерии участия

Критерии включения

  • 14-18 years old
  • Frequent episodic migraine headaches with our without aura (>4 months)
  • Patient at MaineHealth Pediatric Neurology or MaineHealth Pediatrics Portland
  • Current High School Enrollment
  • English Speaking

Критерии исключения

  • Age <14 year or >18 years
  • Diagnosis of eating disorder or Autism Spectrum Disorder
  • PHQ-A scores of 20 or higher
  • Intractable/daily headache
  • Headache secondary to specific medical or neurological conditions (e.g. brain tumor, infection, trauma)
  • Increase in prophylactic headache medication 6 weeks prior to the onset of intervention

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • MaineHealth Pediatric Neurology — Scarborough

Идентификаторы

NCT: NCT07373275 · mainehealth

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗