Behavioral Weight Loss Intervention for Migraine: A Randomized Controlled Trial

OBJECTIVE: To test whether behavioral weight loss (BWL) intervention decreases headaches in women with comorbid migraine and overweight/obesity. METHODS: This randomized, single-blind trial allocated women [18–50 years old, 4–20 migraine days/month, Body Mass Index (BMI)=25.0–49.9 kg/m(2)] to 16 weeks of BWL, (n=54) that targeted exercise and eating behaviors for weight loss, or Migraine Education control (ME, n=56) that delivered didactic instruction on migraine and treatments. Participants completed a 4-week smartphone headache diary at baseline, post-treatment (16–20 weeks) and follow-up (32–36 weeks). The primary outcome was post-treatment change in migraine days/month, analyzed via linear mixed effects models. RESULTS: Of 110 participants randomized, 85 (78%) and 80 (73%) completed post-treatment and follow-up. Although BWL achieved greater weight loss [mean (95% CI) kg] vs. ME at post-treatment [−3.8 (−2.5, −5.0) vs. +0.9 (−0.4,2.2) p<.001] and follow-up [−3.2 (−2.0, −4.5) vs. +1.1 (−0.2,2.4), p<.001], there were no significant group (BWL vs. ME) differences [mean (95%CI)] migraine days/month at post-treatment [−3.0 (−2.0, −4.0) vs. −4.0 (−2.9, −5.0), p=.185] or follow-up [−3.8 (−2.7, −4.8) vs. −4.4 (−3.4, −5.5), p=.378]. CONCLUSION: Contrary to hypotheses, BWL and ME yielded similar, sustained reductions in migraine headaches. Future research should evaluate whether adding BWL to standard pharmacologic and/or non-pharmacologic migraine treatment approaches yields greater benefits.