Healthy Living Partnerships for Veterans With Migraine

NCT04373330 | Withdrawn

• 2 other identifiers: IRB00064225UL1TR001420
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Migraine; Migraine Disorders; Migraine With Aura; Migraine Without Aura

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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.

  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

  6 month

Study Arms (2)

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.

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.

Interventions

Intensive Lifestyle Intervention BEHAVIORAL

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.

Intensive lifestyle intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• W.G. Bill Hefner Medical Center: collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

MeSH Terms

Conditions

Migraine Disorders; Migraine with Aura; Migraine without Aura

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Mara Vitolins, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 4, 2020
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 2, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share