Behavioral Weight Loss as a Treatment for Migraine in Obese Women

Migraine is a highly prevalent, debilitating and costly disorder. Eighteen percent of women
and 6% of men are affected by migraine; a neurovascular disorder characterized by severe
recurrent headache pain episodes involving nausea, photophobia, phonophobia and aversion to
physical activity.

There is increasing evidence that obesity exacerbates migraine. Obesity is associated with
more frequent headaches in episodic migraineurs, and is a risk factor for progression to
chronic migraine. Several plausible mechanisms have been proposed to underlie the
migraine-obesity link including common pro-inflammatory processes, psychological conditions
that are comorbid to both disorders (e.g., depression), and similar behavioral risk factors
(e.g., low physical activity and high fat intake).

No research to date has examined the impact of standard behavioral weight loss programs on
migraine in obese adults. Behavioral weight loss programs focused on improving diet and
physical activity consistently produce weight losses of 8-10 kg at 6 months which reduces
the risk of diabetes and improves cardiovascular disease risk factors. Weight loss may also
improve each of the physiological, psychological, and behavioral pathways that purportedly
link migraine and obesity. Thus, behavioral weight loss programs may serve as an innovative
approach to treating migraine headaches.

This study involves a randomized controlled trial to examine the efficacy of behavioral
weight loss as a treatment for migraine. One hundred and forty obese females who meet
research criteria for migraine, as confirmed by a study neurologist and completion of an
electronic headache diary will be assigned to 16 weekly group sessions of either: (1)
Behavioral weight loss (BWL) treatment (n=70) or (2) Healthy Living for Migraine Relief
(HLMR) education (n=70). BWL will provide a combination of empirically validated diet and
exercise prescriptions and behavior change strategies such as self-monitoring, goal-setting
and stimulus control. HLMR will provide education on migraine and pharmacological and
behavioral (e.g., stress management) treatments. Both groups will use smartphones to record
their headaches for 4 weeks at a time during pre-treatment, post-treatment, and the end of a
16-week weight maintenance period. Weight and other potential physiological (inflammation),
psychological (depression), and behavioral (diet and physical activity) mediators of the
treatment effect will be assessed at the end of treatment for tests of prospective effects
on migraine days at post-treatment. The primary hypothesis is that BWL participants will
report greater pre- to post-treatment reductions in number of migraine days than HLMR
participants.

Inclusion criteria:

- Neurologist-confirmed diagnosis of migraine with or without aura

- Experience at least 3 headaches and 4-20 headache days per month

- Body Mass Index of 25.0-49.9 kg/m2

Exclusion criteria:

- Have primary headache disorder other than migraine or tension-type headache

- Have both migraine and tension-type headache and are unable to distinguish the two
headache types and/or report 2 or more tension-type headaches per month

- Have a secondary headache disorder

- Have initiated or changed prophylactic medications within 2 months of study entry, or
intend to change these medications during the trial

- Have changed medications used to abort migraine attacks, treat depression, or provide
oral contraception within 2 months of study entry, or intend to change these
medications during the trial.

- Have experienced recent weight loss (>=5% within the past 6 months), are currently
involved in a commercial weight loss program, are presently taking weight loss
medications, or have had bariatric surgery.

- Are pregnant, were pregnant within the last 6 months, or plan to become pregnant
during the trial.

- Report a heart condition, chest pain during periods of activity or rest, or loss of
consciousness on the Physical Activity Readiness Questionnaire. Individuals reporting
joint problems, prescription medication usage, or other medical conditions that could
limit exercise participation will be required to obtain written physician consent to
participate.

- Have been diagnosed with cancer or are currently undergoing cancer treatment.

- Are unable to read or understand the study materials.

- Report any condition that in the opinion of investigators would reduce the likelihood
of adherence to the headache monitoring protocol or clinical trial prescriptions,
including terminal illness, planning to relocate, or a history of substance abuse,
bulimia nervosa, or other significant psychiatric problems.