Behavioral Weight Loss as a Treatment for Migraine in Obese Women

描述(申请人提供)：偏头痛是一个主要的健康问题。大约18%的美国女性和6%的男性受到偏头痛的影响；偏头痛是一种以反复头痛为特征的神经血管疾病。越来越多的证据表明，肥胖会以更频繁和更严重的头痛的形式加剧偏头痛。已经提出了几种合理的机制来解释肥胖和偏头痛之间的联系，包括共同的炎症过程、与这两种疾病并存的心理状况，以及类似的行为风险因素。到目前为止，还没有研究检查行为减肥(BWL)对偏头痛的影响。BWL计划专注于改善饮食和体力活动，持续在6个月内减重8-10公斤，从而显着改善心血管健康。减肥对上述每一条据称将偏头痛和肥胖联系在一起的途径都有有益的影响。因此，BWL计划可能成为治疗偏头痛的一种创新方法。我们的试点工作表明，在1)减肥手术和2)BWL试点计划产生体重减轻后，肥胖偏头痛患者的偏头痛得到改善。在研究1中，24名严重肥胖的偏头痛患者的偏头痛天数从减肥手术前的6个月减少到6个月，其中近一半的患者报告至少减少了50%。在研究2中，8名肥胖女性偏头痛患者在16wk BWL计划后偏头痛天数减少了61%。这些发现为在全面试验中测试BWL提供了理由。我们建议进行一项随机试验，以检验BWL作为偏头痛治疗的疗效。我们将随机分配140名经研究神经学家证实患有发作性偏头痛的肥胖女性，并在4周的基线期间记录3次头痛和4-14天的头痛，16组每周接受BWL治疗(n=70)或偏头痛缓解健康生活(HLMR；n=70)对照组。BWL将提供经验证的饮食和运动处方以及BWL策略的组合。HLMR将提供有关偏头痛以及药物和行为(例如，压力管理)治疗的教育。在治疗前、治疗后(第17-20周)和16wk体重维持期结束(第29-32周)期间，两组患者都将使用智能手机记录他们的头痛情况，每次持续4周。治疗结束时(WK 16)将评估体重和其他潜在的生理(炎症)、心理(抑郁)和行为(饮食和运动)调节因素，以测试治疗后偏头痛日的预期效果。基本假设是，与HLMR参与者相比，BWL参与者报告的偏头痛天数在治疗前和治疗后的减少程度更大。该项目具有很高的创新性，因为它是第一个测试BWL治疗偏头痛疗效的项目。鉴于偏头痛和肥胖都是普遍的、令人衰弱的和代价高昂的疾病，这项研究的发现有可能对公众健康产生重要的益处。

DESCRIPTION (provided by applicant): Migraine is a major health problem. Approximately 18% of American women and 6% of men are affected by migraine; a neurovascular disorder characterized by recurrent headaches. Increasing evidence suggests that obesity exacerbates migraine in the form of more frequent and severe headaches. Several plausible mechanisms have been proposed to account for the obesity-migraine link including common inflammatory processes, psychological conditions that are co morbid to both disorders, and similar behavioral risk factors. No research to date has examined the impact of behavioral weight loss (BWL) on migraine. BWL programs focused on improving diet and physical activity consistently producing weight losses of 8-10 kg at 6 months which yield significant improvements in cardiovascular health. Weight loss also has beneficial effects on each of the above pathways that purportedly link migraine and obesity. Thus, BWL programs may serve as an innovative approach to treating migraine headaches. Our pilot work suggests that migraine headaches are improved in obese migraineurs after weight loss produced by 1) bariatric surgery and 2) a pilot BWL program. In study 1, migraine days were reduced in 24 severely obese migraineurs from pre- to 6-months post-bariatric surgery, with nearly half of these patients reporting at least a 50% reduction. In study 2, migraine days were reduced by 61% in 8 obese female migraineurs after a 16 wk BWL program. These findings provide justification for testing BWL in a full-scale trial. We propose to conduct a randomized trial to examine the efficacy of BWL as a treatment for migraine. We will randomly assign 140 obese women who have episodic migraine, as confirmed by the study neurologist, and record e 3 headaches and 4-14 headache days during a 4-wk baseline period to 16 weekly group sessions of either: BWL treatment (n=70) or Healthy Living for Migraine Relief (HLMR; n=70) control. BWL will provide a combination of empirically validated diet and exercise prescriptions and BWL strategies. HLMR will provide education on migraine and pharmacological and behavioral (e.g., stress management) treatments. Both groups will use smart phones to record their headaches for 4 wks at a time during pre-treatment, post-treatment (wks 17-20), and the end of a 16 wk weight maintenance period (wks 29-32). Weight and other potential physiological (inflammation), psychological (depression), and behavioral (diet and exercise) mediators of the treatment effect will be assessed at the end of treatment (wk 16) 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. This project is highly innovative because it is the first to test the efficacy of BWL for treatment of migraine headaches. Given that both migraine and obesity are prevalent, debilitating and costly disorders, findings from this study have the potential to be of important public health benefit.