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临床试验/NCT07373275
NCT07373275Enrolling By Invitation不适用

Investigating Lifestyle Medicine Interventions for Adolescent Headache Relief

MaineHealth1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
MaineHealth
入组人数
50
试验地点
1
主要终点
Attendance

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

盲法说明

No one will be masked in this study.

入排标准

年龄范围
14 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

The Lifestyle Medicine Intervention Arm

Experimental

All participants will receive the Lifestyle Medicine Group Medical Visit intervention, whether they are in group 1 or group 2.

干预措施: Lifestyle Medicine Group Medical Visits (Behavioral)

结局指标

主要结局

Attendance

时间窗: From enrollment to end of treatment at 3 months

For this outcome, we will track how often participants attend the group meetings. There will be seven group meetings to attend, one per week. Attendance will be tracked at each meeting by group facilitators. We will calculate the overall percentage of attendance for each participant over the seven weeks and report the mean percentage. We anticipate \>75% attendance to be successful.

Headache Diary Completion

时间窗: From enrollment to end of treatment at 3 months

For this outcome, we will track how often participants attend the group meetings. There will be seven group meetings to attend, one per week. Attendance will be tracked at each meeting by group facilitators. We will calculate the overall percentage of attendance for each participant over the seven weeks and report the mean percentage. We anticipate \>75% attendance to be successful.

次要结局

  • Positive Lifestyle Changes(From enrollment to end of treatment at three months)
  • Headache Symptoms(From enrollment through 3 months.)
  • Headache Severity(From enrollment through 3 months.)
  • Headache Symptom Reduction(From enrollment through 3 months.)

研究者

发起方
MaineHealth
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Dubail

MD

MaineHealth

研究点 (1)

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