The Effects of Treating Insomnia on Behavioral Weight Loss Outcomes in Survivors of Breast Cancer

超重和肥胖在美国非常普遍，并与乳腺癌风险增加有关， 降低了治疗效果，增加了复发、医学并发症和死亡的风险。乳腺癌 存活率正在增加，并与体重增加，脂肪量增加，失眠和疾病风险有关， 使乳腺癌存活率成为主要的医疗优先事项。减肥是一个标准的治疗指南， 超重/肥胖的乳腺癌患者;然而， 减肥通常是具有挑战性的，特别是对于那些经历过乳腺癌治疗的人来说。 虽然有几项试验已经测试了行为减肥（BWL）对乳腺癌幸存者的影响， 相当大比例的患者没有达到临床上显著的体重减轻。失眠症也是高度 在乳腺癌患者中普遍存在，并且与肥胖一样，可以预测乳腺癌的风险、进展和死亡。 研究表明，睡眠不足可能直接导致肥胖和损害减肥的努力 通过许多行为和生物途径。一些研究表明，认知行为疗法， 失眠症（CBT-I）在治疗乳腺癌幸存者中是有效的。一种方法还有待在一个 然而，大规模研究在BWL干预之前增加了改善睡眠质量的干预。我们 初步数据表明，CBT-I可以提高早期乳腺癌妇女的减肥效果， （ESBC）。尽管睡眠、肥胖和饮食/体力活动之间复杂的、相互关联的机制 行为才刚刚开始探索，我们假设改善失眠将催化减肥 努力和增强BWL对饮食和身体活动行为的影响。我们提出了一个随机的 对照临床试验，以测试在8周内进行的6次CBT-I干预是否与 通过远程医疗（音频-视频）提供的一年BWL干预（CBT-I+BWL）上级睡眠教育 对照条件（EDU）结合BWL（EDU+BWL）在250例ESBC的成年女性幸存者中， 超重或肥胖并失眠。将在随机化时、CBT-I/EDU后进行评估， 以及3个月、6个月和12个月的BWL。我们有以下目标：目标1：评估短期（3个月），中期 （6个月）和长期（12个月）的CBT-I+BWL相比，EDU+BWL对体重减轻的影响（% TWL 12个月， 身体成分（次要）。目标2：评估12个月的体重减轻程度 通过睡眠治疗前后睡眠参数（睡眠效率，SE;总睡眠时间， TST）。探索性目标3：确定CBT-I+BWL是否会改变热量摄入、饮食质量和/或体力活动 相对于EDU+BWL，并评估这些因素与睡眠连续性相关的程度， 在3个月、6个月和12个月时体重减轻。这种新的方法来解决减肥治疗中的睡眠障碍 有可能对肥胖症的治疗产生重大影响，并促进幸存者的管理。 关于ESBC

Overweight and obesity are highly prevalent in the U.S. and are associated with increased breast cancer risk, reduced treatment efficacy, and increased risk of recurrence, medical comorbidity and mortality. Breast cancer survivorship is increasing, and is associated with weight gain, increased fat mass, insomnia, and disease risk, making breast cancer survivorship a major healthcare priority. Weight loss is a standard treatment guideline for individuals with breast cancer with overweight/obesity; however, achieving clinically significant and sustained weight loss is challenging in general, and particularly for those who have undergone breast cancer treatment. While several trials have tested the effects of behavioral weight loss (BWL) in breast cancer survivors, a significant percentage of patients do not achieve clinically significant weight loss. Insomnia disorder is also highly prevalent in individuals with breast cancer and, like obesity, predicts breast cancer risk, progression and death. Research demonstrates that inadequate sleep may directly contribute to obesity and impair weight loss efforts via many behavioral and biological pathways. Several studies demonstrate that cognitive-behavioral therapy for insomnia (CBT-I) is efficacious in treating breast cancer survivors. One approach that has yet to be tested in a large scale study, however, is adding an intervention to improve sleep quality before a BWL intervention. Our preliminary data suggest that CBT-I may enhance weight loss outcomes in women with early stage breast cancer (ESBC). Although the complex, inter-related mechanisms linking sleep, obesity and dietary/physical activity behaviors are only beginning to be explored, we hypothesize that improving insomnia will catalyze weight loss efforts and enhance the effects of BWL on dietary and physical activity behaviors. We propose a randomized controlled clinical trial to test whether a 6-session CBT-I intervention delivered over 8-weeks combined with a one-year BWL intervention (CBT-I+BWL) delivered via telehealth (audio-video) is superior to a sleep education control condition (EDU) combined with BWL (EDU+BWL) among 250 adult female survivors of ESBC who are overweight or obese and have insomnia. Assessments will be conducted at randomization, after CBT-I/EDU, and at 3-, 6-, and 12-months of BWL. We have the following aims: Aim 1: Evaluate the short (3 mo), intermediate (6 mo), and long-term (12-mo) effects of CBT-I+BWL compared to EDU+BWL on weight loss (% TWL 12-months, primary) and body composition (secondary). Aim 2: Evaluate the extent to which 12-month weight loss is mediated by pre to post sleep treatment changes in sleep parameters (Sleep Efficiency, SE; Total Sleep Time, TST). Exploratory Aim 3: Determine whether CBT-I+BWL alters caloric intake, diet quality and/or physical activity relative to EDU+BWL and evaluate the extent to which these factors are associated with sleep continuity and weight loss at 3, 6 and 12-months. This novel approach to addressing sleep disturbances in weight loss treatment has the potential to substantially impact the treatment of obesity and to advance the management of survivors of ESBC.