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Adolescent Lifestyle Medicine Headache Study

NCT07373275 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Headache, Migraine

Interventions

BEHAVIORAL

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 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.

Sponsors & Collaborators

  • MaineHealth

    lead OTHER

Principal Investigators

  • Jennifer Dubail, M.D. · MaineHealth

  • Helis Jason, M.D. · MaineHealth

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2027-03-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07373275 on ClinicalTrials.gov