Headache, MigraineNCT07373275
Adolescent Lifestyle Medicine Headache Study
A study testing Lifestyle Medicine Group Medical Visits in people with Headache, Migraine, run by MaineHealth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache, Migraine
- What is being tested?
- Lifestyle Medicine Group Medical Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MaineHealth Pediatric Neurology
Scarborough, Maine, 04074
About this study
Official title: Investigating Lifestyle Medicine Interventions for Adolescent Headache Relief
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.
Read the detailed 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).
- Conditions
- Headache, Migraine
- Being tested
- Lifestyle Medicine Group Medical Visits
- Keywords
- Lifestyle Medicine, Adolescent, Implementation Science, headache, migraine
- Medical subject headings
- Migraine Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle Medicine Group Medical VisitsBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Lifestyle Medicine Group Medical Visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment to end of treatment at 3 months
Secondary outcomes (4)
Positive Lifestyle Changes
For this outcome, participants will be taking the survey Pediatric Lifestyle Medicine Assessment for Headache. This survey assesses nutrition and sleep. They will take this survey at their intake appointment and 7 weeks following the conclusion group medical visit sessions. For sleep, we anticipate measuring success through an increase in one hour or more of sleep nightly over the course of three surveys; we anticipate measuring nutrition through a decrease in skipped breakfasts by 25%.
Measured: From enrollment to end of treatment at three months
Headache Symptoms
For this outcome, participants will be filling out a daily headache diary, texted automatically through RedCAP. The first question asks if they had a headache in the last 24 hours, yes or no. To calculate the presence of headache in participants, we will [Anya? How do we get our number and what does the number mean?] A logistic mixed effects regression model will be used with a fixed effect for day and a random effect for participant to determine if the odds of headache decreases over time.
Measured: From enrollment through 3 months.
Headache Severity
or this outcome, participants will be filling out a daily headache diary, texted automatically through RedCAP. If participants answer yes to headache presence in the first question, they will be asked a series of other questions. One question asks about headache severity, using a Likert scale. To analyze this, we will assign absence of headache as 0, and assess improvement in severity over time using a linear mixed effects model with a fixed effect for day and a random effect for participant.
Measured: From enrollment through 3 months.
Headache Symptom Reduction
For this outcome, participants will be taking a commonly, clinically-used headache symptom survey, the Peds-MIDAS. The Peds-MIDAS will be adapted to be taken at 6 week intervals (Peds-MIDAS6w). Participants will take the Peds-MIDAS6w at their intake session, at their final group session, and 7 weeks following the completion of the study. They will score from 0-50, with 50 being the most severe. To assess improvement over time, we will use a linear mixed effects regression model with a random effect for participant, with success measured by a decrease in patient score by 10%.
Measured: From enrollment through 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start10 Feb 2026
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Headache, MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Dubail, MaineHealth
- Investigators
- Jennifer Dubail, M.D., Principal investigator, MaineHealthHelis Jason, M.D., Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373275
- Sponsor's protocol ID
- mainehealth
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Lifestyle Medicine Interventions for Adolescent Headache Relief
- ClinicalTrials.gov ID
- NCT07373275
- Acronym / sponsor ID
- mainehealth
- Conditions
- Headache, Migraine
- Keywords
- Lifestyle Medicine, Adolescent, Implementation Science, headache, migraine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| The Lifestyle Medicine Intervention Arm | Experimental | Behavioral: Lifestyle Medicine Group Medical VisitsAll participants will receive the Lifestyle Medicine Group Medical Visit intervention, whether they are in group 1 or group 2. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle Medicine Group Medical VisitsParticipants 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. | Behavioural | The Lifestyle Medicine Intervention Arm |
Primary outcome
Attendance
Time frame: 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
Time frame: 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.
4 secondary outcomes
Positive Lifestyle Changes
Time frame: From enrollment to end of treatment at three months
Headache Symptoms
Time frame: From enrollment through 3 months.
Headache Severity
Time frame: From enrollment through 3 months.
Headache Symptom Reduction
Time frame: From enrollment through 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No. IPD will not be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer Dubail, M.D. principal investigator
MaineHealth
Helis Jason, M.D. principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle Medicine Group Medical Visits in people with Headache, Migraine, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance (time frame: From enrollment to end of treatment at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.