Behavioral Weight Loss as a Treatment for Migraine in Obese Women

描述（由申请人提供）：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形式加剧偏头痛。已经提出了几种合理的机制来解释肥胖-偏头痛的联系，包括常见的炎症过程，与两种疾病共病的心理状况，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育活动，在6个月内持续减轻8-10公斤的体重，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起来的途径也有有益的影响。因此，BWL项目可能是治疗偏头痛的一种创新方法。 我们的试点工作表明，偏头痛改善肥胖偏头痛患者体重减轻后，1）减肥手术和2）试点BWL计划。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术后6个月减少，其中近一半患者报告至少减少50%。在研究2中，8名肥胖女性偏头痛患者在接受16周BWL治疗后，偏头痛天数减少了61%。这些发现为在全面试验中测试BWL提供了依据。 我们建议进行一项随机试验，以检查BWL作为治疗偏头痛的疗效。我们将140名患有发作性偏头痛的肥胖妇女随机分配，并由研究神经学家证实，在4周的基线期内记录3次头痛和4-14次头痛日，分为16个每周一次的组：BWL治疗（n=70）或健康生活缓解偏头痛（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将提供关于偏头痛和药理学和行为学的教育（例如，压力管理）治疗。两组都将在治疗前、治疗后（第17-20周）和16周体重维持期结束时（第29-32周）使用智能手机记录他们的头痛，每次4周。在治疗结束时（第16周）评估治疗效果的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，以测试治疗后偏头痛日的前瞻性影响。主要假设是BWL参与者将报告比HLMR参与者更大的治疗前至治疗后偏头痛天数减少。 这个项目是高度创新的，因为它是第一个测试BWL治疗偏头痛的疗效。鉴于偏头痛和肥胖都是普遍的、使人衰弱的和昂贵的疾病，这项研究的结果有可能对公共卫生产生重要的影响。

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.