Behavioral Weight Loss as a Treatment for Migraine in Obese Women
Condition: Migraine; Obesity
MeSH terms: Migraine Disorders; Weight Loss
Study type: Interventional

Summary: 
      This study involves a randomized controlled trial to test the efficacy of behavioral weight
      loss as a treatment for migraine in obese females aged 18 to 50 years. The primary aim is to
      examine whether participants assigned to a behavioral weight loss treatment condition report
      greater pre- to post-treatment reductions in migraine headache frequency than participants
      assigned to a migraine education condition.
    

Detailed description: 
      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.
    

Intervention name(s): Behavioral Weight Loss Intervention; Migraine Education
Intervention type(s): Behavioral; Other
Intervention description(s): Participants assigned to this condition will receive an intensive group-based lifestyle program modeled after the DPP and Look AHEAD trials. Participants will attend 16 weekly sessions involving provision of behavioral goals and strategies to modify diet and exercise behaviors in order to achieve a weight loss of at least 7% of initial body weight.; Participants assigned to this condition (Healthy Living for Migraine Relief [HLMR]) will receive basic education and didactic instruction in migraine headaches and treatments that are the standard of care. Participants will attend 4 months of weekly group lectures focused on 3 different major topic areas: 1) migraine symptomatology and pathophysiology, 2) standard abortive and preventive pharmacological treatment options, and 3) standard and alternative non-pharmacological treatment options.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Obesity; Weight loss; Lifestyle; Behavior