Adolescent Lifestyle Medicine Headache Study

NCT07373275 | Enrolling By Invitation

• 1 other identifier: mainehealth
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lifestyle Medicine; Adolescent; Implementation Science; headache; migraine

Outcome Measures

Primary Outcomes (2)

• Attendance

  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.

  From enrollment to end of treatment at 3 months

• Headache Diary Completion

  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.

  From enrollment to end of treatment at 3 months

Secondary Outcomes (4)

• 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.

Study Arms (1)

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.

Behavioral: Lifestyle Medicine Group Medical Visits

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.

The Lifestyle Medicine Intervention Arm

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

MaineHealth Pediatric Neurology

Scarborough, Maine, 04074, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Dubail, M.D.

  MaineHealth

  PRINCIPAL INVESTIGATOR

• Helis Jason, M.D.

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No one will be masked in this study.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: This is an Implementation Science study to assess the feasibility of using Lifestyle Medicine Group Medical Visits for adolescents with headache. We are using two groups with a step wedge design; both groups are getting the same intervention.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 28, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)