MigraineHELP-VMNCT04373330
Healthy Living Partnerships for Veterans With Migraine
A study testing Intensive Lifestyle Intervention in people with Migraine and Migraine Disorders, run by Wake Forest University Health Sciences.
Trial summary
This pilot study, modeled upon the successful and empirically validated HELP Prevent Diabetes Intervention, incorporates a migraine education component describing the links between lifestyle behaviors and migraine activity (e.g., frequency, impairment) into an existing lifestyle intervention used previously for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine, Migraine Disorders, Migraine With Aura
- What is being tested?
- Intensive Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Demographics: Community dwelling men and women Veterans (21 years of age and older) of all races/ethnicities seen as patients at the Kernersville Health Care Center.
- Headache Diagnosis, frequency, and chronicity: All participants will be required to have a diagnosis of chronic migraine as per ICHD-IIIβ criteria24. Those with headache frequency ≥ 15 headache days per month for more than three months will be eligible to participate.
- Willingness to Accept Randomization: Prospective participants must be willing to accept randomization to either the intensive lifestyle intervention or the comparison intervention condition.
- Baseline Physician Activity Level: At the time of enrollment, prospective participants must not be participating in a regular physical activity or exercise regimen, and should meet the criteria for "sedentary" (i.e., does not report current engagement in vigorous or moderate activity) on the International Physical Activity Questionnaire Short form (IPAQ-SF).
Who cannot join
- Other painful conditions: A diagnosis of headache disorder other than chronic migraine (eg, cluster headache or medication overuse headache as per ICHD-IIIβ criteria24) or characterizes a pain disorder other than migraine as their primary presenting problem.
- Non-stable headache treatment regimen: Reports a change in physician prescribed preventive or acute headache pharmacotherapy within three weeks prior to enrollment or anticipates a change in preventive headache pharmacotherapy during the study period.
- Recent history of cardiovascular disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure. All persons with recent CVD should be participating in cardiac rehabilitation (with appropriate supervision as indicated) to reduce their risk of recurrence; hence, randomization might raise ethical concerns.
- Hypertension: Uncontrolled high blood pressure: BP > 160/100 mmHg. Potential participants can be re-screened after controlled.
- Pregnancy, planning pregnancy and breast feeding (self-report) during screening: Pregnancy, breast feeding, or planning pregnancy within the next year.
- Physical preparedness for exercise: Those screening positive on the Physical Activity Readiness Questionnaire (PAR-Q)25 those must obtain physician clearance prior to participation, and will be excluded unless the clearance is obtained and documented.
- Other Medical and Psychiatric Conditions: Candidates will be screened for other co-morbid conditions that could make physical activity unsafe or limit participation. This includes other chronic disease likely to limit lifespan to less than 2-3 years (eg, any cancer requiring treatment in past 5 years except non-melanoma skin cancer), elevated depressive symptoms and/or suicidal ideation (Patient Health Questionnaire (PHQ-9)28,29), anxiety levels that could interfere with participation in this trial (PROMIS-29 Anxiety Subscale30-32, and evidence of opioid use disorder (Current Opioid Misuse Measure (COMM)33).
- Other: Conditions/criteria likely to interfere with participation and acceptance of randomized assignment, including the following: inability/unwillingness to give informed consent, another household member already randomized to HELP-VM, evidence of major psychiatric or cognitive problems (schizophrenia, dementia, self-reported active illegal substance or alcohol abuse), participation in another research study that would interfere with HELP-VM.
About this study
This pilot study, modeled upon the successful and empirically validated HELP Prevent Diabetes Intervention, incorporates a migraine education component describing the links between lifestyle behaviors and migraine activity (e.g., frequency, impairment) into an existing lifestyle intervention used previously for Veterans at risk for developing Type II diabetes. The principal objectives of this research are to assess the feasibility, acceptability (recruitment), engagement (retention, adherence), and promise of implementing the HELP-VM at the Salisbury. To achieve our objectives, the investigators propose to assess the acceptability of HELP-VM by determining our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program, to evaluate the feasibility of implementing HELP-VM by assessing Veterans' adherence to HELP-VM and our capacity to retain them in a clinical trial, and to evaluate the promise of HELP-VM by obtaining preliminary data to estimate variances of primary (headache frequency, headache-related impairment) and secondary/exploratory outcome measures (e.g., emotional distress, use of analgesics/opiates, headache self-efficacy, pain catastrophizing) to inform a future, large-scale trial.
Read the detailed description
Headache disorders such as migraine occur commonly among Veterans and contribute to disability and reduced quality of life. Veterans with migraine are more likely than those without headache to experience medically related discharge/retirement, post-traumatic stress disorder, sleep disturbances, and difficulty reintegrating back into civilian life.
Despite advances in our understanding of migraine, it remains poorly understood and often proves refractory to validated drug and non-drug interventions. Therefore, there is tremendous potential value in pursuing alternate intervention pathways for migraine management. Although empirical support remains limited, engagement in regular exercise routinely is recommended for managing and preventing migraine.
This innovative approach, if successful, could be disseminated rapidly to the VAMC in the United States, thereby making a substantial impact on the public health burden of migraine and other lifestyle related chronic diseases amongst our nation's Veterans. Consistent with the VA's Whole Health Initiative, this HELP-VM approach facilitates and supports Veterans' capacity to take charge of their own health and well-being, and recognizes the many health benefits of reducing sedentary activity for migraine and beyond.
- Being tested
- Intensive Lifestyle Intervention
- Medical subject headings
- Migraine Disorders, Migraine with Aura, Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle InterventionBehavioural
There will be 14 sessions delivered over the course of 6 months; materials consist of CHW lesson plans, participant workbooks, and the DVD series. These materials will be adapted for use in HELP-VM and will include information on migraine and its management as well as mental health resources available to Veterans for common illnesses like depression and post-traumatic stress disorder and modifying physical activity recommendations for Veterans with limited mobility.
| Study group | Role | What they receive |
|---|---|---|
| Intensive lifestyle intervention | Experimental | The intensive lifestyle intervention used in HELP PD and that will be used in HELP-VM was a modification of the successful Diabetes Prevention Program (DPP) core curriculum adapted for use in groups. The 16-session core curriculum used in DPP, covering key concepts related to energy balance, nutrition, and physical activity, was expanded to include regular sessions focused on group problem-solving of barriers and issues specific to the members and to incorporate presentations from local community groups on topics relevant to healthy living (exercise resources, etc.) The same intervention will be used in HELP-VM and will target moderate intensity physical activity (goal ≥180 min/wk). A DVD series was developed in HELP PD to standardize this core content, improve fidelity of intervention delivery, and to allow the CHWs to focus on group facilitation and problem-solving. This DVD series will also be used in HELP-VM. Receives: Behavioral: Intensive Lifestyle Intervention |
| Medical Treatment as Usual | No intervention | Subjects randomized to MTAU will be encouraged to continue engaging in medical treatment as per their usual. The MTAU group will complete baseline and 6-month follow-up assessments, and participants will complete daily symptom self-monitoring on the same schedule as HELP-VM participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability- Number of participants recruited
To assess the acceptability of HELP-VM, the investigators will determine our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program
Measured: 6 month
Percentage of adherence to HELP-VM
To evaluate the feasibility of implementing HELP-VM, the investigators will assess Veterans' adherence to HELP-VM
Measured: 6 month
Number of participants that complete the intervention
To evaluate the feasibility of implementing HELP-VM, the investigators will assess our capacity to retain them in a clinical trial.
Measured: 6 month
Mean of primary headache frequency
To evaluate the promise of HELP-VM, the investigators will obtain preliminary data to estimate variances (mean/SD) of primary headache frequency
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Why it stopped: lack of Personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- W.G. Bill Hefner Medical Center, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Mara Vitolins, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373330
- Sponsor's protocol ID
- IRB00064225
- Other IDs
- UL1TR001420
- Acronym
- HELP-VM
- Status last verified
- Feb 2025
- First submitted
- 29 Apr 2020
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Living Partnerships for Veterans With Migraine
- ClinicalTrials.gov ID
- NCT04373330
- Acronym / sponsor ID
- HELP-VM / IRB00064225
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of Personnel
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- W.G. Bill Hefner Medical Center, National Center for Advancing Translational Sciences (NCATS)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 4 May 2020 (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.
This pilot study, modeled upon the successful and empirically validated HELP Prevent Diabetes Intervention, incorporates a migraine education component describing the links between lifestyle behaviors and migraine activity (e.g., frequency, impairment) into an existing lifestyle intervention used previously for Veterans at risk for developing Type II diabetes. The principal objectives of this research are to assess the feasibility, acceptability (recruitment), engagement (retention, adherence), and promise of implementing the HELP-VM at the Salisbury. To achieve our objectives, the investigators propose to assess the acceptability of HELP-VM by determining our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program, to evaluate the feasibility of implementing HELP-VM by assessing Veterans' adherence to HELP-VM and our capacity to retain them in a clinical trial, and to evaluate the promise of HELP-VM by obtaining preliminary data to estimate variances of primary (headache frequency, headache-related impairment) and secondary/exploratory outcome measures (e.g., emotional distress, use of analgesics/opiates, headache self-efficacy, pain catastrophizing) to inform a future, large-scale trial.
Detailed description
Headache disorders such as migraine occur commonly among Veterans and contribute to disability and reduced quality of life. Veterans with migraine are more likely than those without headache to experience medically related discharge/retirement, post-traumatic stress disorder, sleep disturbances, and difficulty reintegrating back into civilian life.
Despite advances in our understanding of migraine, it remains poorly understood and often proves refractory to validated drug and non-drug interventions. Therefore, there is tremendous potential value in pursuing alternate intervention pathways for migraine management. Although empirical support remains limited, engagement in regular exercise routinely is recommended for managing and preventing migraine.
This innovative approach, if successful, could be disseminated rapidly to the VAMC in the United States, thereby making a substantial impact on the public health burden of migraine and other lifestyle related chronic diseases amongst our nation's Veterans. Consistent with the VA's Whole Health Initiative, this HELP-VM approach facilitates and supports Veterans' capacity to take charge of their own health and well-being, and recognizes the many health benefits of reducing sedentary activity for migraine and beyond.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive lifestyle intervention | Experimental | Behavioral: Intensive Lifestyle InterventionThe intensive lifestyle intervention used in HELP PD and that will be used in HELP-VM was a modification of the successful Diabetes Prevention Program (DPP) core curriculum adapted for use in groups. The 16-session core curriculum used in DPP, covering key concepts related to energy balance, nutrition, and physical activity, was expanded to include regular sessions focused on group problem-solving of barriers and issues specific to the members and to incorporate presentations from local community groups on topics relevant to healthy living (exercise resources, etc.) The same intervention will be used in HELP-VM and will target moderate intensity physical activity (goal ≥180 min/wk). A DVD series was developed in HELP PD to standardize this core content, improve fidelity of intervention delivery, and to allow the CHWs to focus on group facilitation and problem-solving. This DVD series will also be used in HELP-VM. |
| Medical Treatment as Usual | No intervention | –Subjects randomized to MTAU will be encouraged to continue engaging in medical treatment as per their usual. The MTAU group will complete baseline and 6-month follow-up assessments, and participants will complete daily symptom self-monitoring on the same schedule as HELP-VM participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Demographics: Community dwelling men and women Veterans (21 years of age and older) of all races/ethnicities seen as patients at the Kernersville Health Care Center.
- Headache Diagnosis, frequency, and chronicity: All participants will be required to have a diagnosis of chronic migraine as per ICHD-IIIβ criteria24. Those with headache frequency ≥ 15 headache days per month for more than three months will be eligible to participate.
- Willingness to Accept Randomization: Prospective participants must be willing to accept randomization to either the intensive lifestyle intervention or the comparison intervention condition.
- Baseline Physician Activity Level: At the time of enrollment, prospective participants must not be participating in a regular physical activity or exercise regimen, and should meet the criteria for "sedentary" (i.e., does not report current engagement in vigorous or moderate activity) on the International Physical Activity Questionnaire Short form (IPAQ-SF).
Key exclusion criteria (8 listed)
- Other painful conditions: A diagnosis of headache disorder other than chronic migraine (eg, cluster headache or medication overuse headache as per ICHD-IIIβ criteria24) or characterizes a pain disorder other than migraine as their primary presenting problem.
- Non-stable headache treatment regimen: Reports a change in physician prescribed preventive or acute headache pharmacotherapy within three weeks prior to enrollment or anticipates a change in preventive headache pharmacotherapy during the study period.
- Recent history of cardiovascular disease: Clinical history of cardiovascular disease (CVD) occurring within the past 6 months, including myocardial infarction, angina, coronary revascularization, stroke, TIA, carotid revascularization, peripheral arterial disease, and congestive heart failure. All persons with recent CVD should be participating in cardiac rehabilitation (with appropriate supervision as indicated) to reduce their risk of recurrence; hence, randomization might raise ethical concerns.
- Hypertension: Uncontrolled high blood pressure: BP > 160/100 mmHg. Potential participants can be re-screened after controlled.
- Pregnancy, planning pregnancy and breast feeding (self-report) during screening: Pregnancy, breast feeding, or planning pregnancy within the next year.
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 |
|---|---|---|
| Intensive Lifestyle InterventionThere will be 14 sessions delivered over the course of 6 months; materials consist of CHW lesson plans, participant workbooks, and the DVD series. These materials will be adapted for use in HELP-VM and will include information on migraine and its management as well as mental health resources available to Veterans for common illnesses like depression and post-traumatic stress disorder and modifying physical activity recommendations for Veterans with limited mobility. | Behavioural | Intensive lifestyle intervention |
Primary outcome
Acceptability- Number of participants recruited
Time frame: 6 month
To assess the acceptability of HELP-VM, the investigators will determine our ability to recruit Veterans to participate in the HELP-VM intervention as administered through the existing structure of the Salisbury VAMC's Whole Health Program
Percentage of adherence to HELP-VM
Time frame: 6 month
To evaluate the feasibility of implementing HELP-VM, the investigators will assess Veterans' adherence to HELP-VM
Number of participants that complete the intervention
Time frame: 6 month
To evaluate the feasibility of implementing HELP-VM, the investigators will assess our capacity to retain them in a clinical trial.
Mean of primary headache frequency
Time frame: 6 month
To evaluate the promise of HELP-VM, the investigators will obtain preliminary data to estimate variances (mean/SD) of primary headache frequency
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mara Vitolins, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Lifestyle Intervention in people with Migraine and Migraine Disorders, run by Wake Forest University Health Sciences.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Acceptability- Number of participants recruited (time frame: 6 month). The study lists 4 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 2 Jul 2025.