Behavioral Weight Loss as a Treatment for Migraine in Obese Women

描述（由申请人提供）：偏头痛是一种主要的健康问题。大约18%的美国女性和6%的男性患有偏头痛；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、更严重的头痛形式加剧偏头痛。人们提出了几种合理的机制来解释肥胖与偏头痛之间的联系，包括常见的炎症过程、两种疾病共同发病的心理状况，以及类似的行为风险因素。迄今为止还没有研究检验过行为减肥（BWL）对偏头痛的影响。BWL计划专注于改善饮食和身体活动，在6个月内持续减少8-10公斤的体重，从而显著改善心血管健康。减肥对上述偏头痛和肥胖之间的联系也有有益的影响。因此，BWL项目可以作为治疗偏头痛的一种创新方法。我们的试点工作表明，肥胖偏头痛患者在接受减肥手术和BWL试点项目后，偏头痛得到了改善。在研究1中，24名严重肥胖偏头痛患者的偏头痛天数从减肥手术前到手术后6个月减少了，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16周的BWL项目后偏头痛天数减少了61%。这些发现为在全面试验中测试体重提供了依据。我们建议进行一项随机试验来检验白藜芦醇治疗偏头痛的疗效。我们将随机分配140名患有发作性偏头痛的肥胖女性，经研究神经科医生证实，并在4周的基线期记录3次头痛和4-14天头痛，每周16次组会议：BWL治疗（n=70）或健康生活偏头痛缓解（HLMR; n=70）对照组。BWL将提供经验验证的饮食和运动处方和BWL策略的组合。HLMR将提供有关偏头痛和药理学和行为（如压力管理）治疗的教育。在治疗前、治疗后（第17-20周）和16周体重维持期结束时（第29-32周），两组都将使用智能手机记录他们的头痛情况，每次持续4周。在治疗结束时（第16周）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）介质对治疗效果的影响，以测试治疗后偏头痛天数的预期影响。主要的假设是BWL的参与者在治疗前和治疗后偏头痛天数的减少比HLMR的参与者要多。这个项目是高度创新的，因为它是第一个测试BWL治疗偏头痛功效的项目。鉴于偏头痛和肥胖都是普遍存在的、使人衰弱的、昂贵的疾病，这项研究的发现有可能对公共卫生产生重要的益处。

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.