Adolescent Lifestyle Medicine Headache Study

Part of paid clinical trials in Scarborough, Maine.

Sponsor
MaineHealth
Study ID
NCT07373275
Status
Enrolling By Invitation

Conditions

  • Headache, Migraine

Eligibility Criteria

Sex
ALL
Age
14 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Lifestyle Medicine Group Medical Visits — BEHAVIORAL
    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 that pillar (i.e. eat 2 more vegetables a day for five days). During the course of these 7 weeks, participants will also keep a virtual daily headache journal; a link to this journal will be sent through an automated text with a HIPPA-compliant REDCap database. This will be sent daily at 5 pm.

Study Details

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.

Key Dates

Start date
Feb 10, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: The Lifestyle Medicine Intervention Arm
    All participants will receive the Lifestyle Medicine Group Medical Visit intervention, whether they are in group 1 or group 2.

Primary Outcome Measure

Attendance [ Time Frame: From enrollment to end of treatment at 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
MaineHealth Pediatric NeurologyScarboroughMaine04074-

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MaineHealth Pediatric Neurology· Scarborough, ME

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