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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.
Full description
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).
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50 participants in 1 patient group
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Jason Helis; Jennifer Dubail, M.D.
Data sourced from clinicaltrials.gov
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