Can weight loss improve migraine headaches in obese women? Rationale and design of the Women's Health and Migraine (WHAM) randomized controlled trial

Background: Research demonstrates a link between migraine and obesity. Obesity increases the risk of frequent migraines and is associated with migraine prevalence among reproductive-aged women. These findings are substantiated by several plausible mechanisms and emerging evidence of migraine improvements after surgical and non-surgical weight loss. However, no previous study has examined the effect of weight loss on migraine within a treatment-controlled framework. The WHAM trial is an RCT to test the efficacy of behavioral weight loss as a treatment for migraine. Study design: Overweight/obese women (n=140; BMI=25.0-49.9kg/m²) who meet international diagnostic criteria for migraine and record ≥3 migraines and 4-20 migraine days using a smartphone-based headache diary during a 4-week baseline period, will be randomly assigned to 4months of either group-based behavioral weight loss (intervention) or migraine education (control). Intervention participants will be taught strategies to increase physical activity and consume fewer calories in order to lose weight. Control participants will receive general education on migraine symptoms/triggers and various treatment approaches. Both groups will use smartphones to record their headaches for 4weeks at baseline, after the 16-week treatment period, and at the end of a 16-week follow-up period. Changes in weight and other potential physiological (inflammation), psychological (depression), and behavioral (diet and physical activity) mediators of the intervention effect will also be assessed. Conclusion: The WHAM trial will evaluate the efficacy of a standardized behavioral weight loss intervention for reducing migraine frequency, and the extent to which weight loss and other potential mediators account for intervention effects.