Using Technology to Promote Activity in Women at Elevated Breast Cancer Risk

描述（由申请人提供）：在绝经后妇女中，肥胖（即过量的能量摄入和缺乏身体活动）与乳腺癌风险增加有关。需要有效和实用的干预策略来解决美国中老年妇女中普遍存在的超重和久坐不动的生活方式。虽然基于网络的促进健康生活方式的干预措施很常见，但没有研究测试使用网络集成的身体活动计来促进这一人群的行为改变。通过利用基于创新技术的方法，研究人员和医生可能能够用低成本的替代方案取代高强度的身体活动干预。目的：测试使用基于网络的自我监测技术（FitBit）促进乳腺癌高风险妇女（即超重/肥胖、不运动的绝经后妇女）体育活动的可行性。具体目的：本初步研究建议使用一项为期16周的新干预措施（FitBit活动监测+训练）与计步器的随机对照试验，以解决以下目标：主要目的：调查基于FitBit的干预措施与提供计步器对身体活动和久坐行为的客观测量的影响。次要目的：检查设备和网站的可接受性和使用模式。方法：50名参与者将被随机分配接受(a) FitBit监视器和网站使用培训，或(b)计步器。FitBit是一个小型的身体活动跟踪设备，与一个网站配对，无线上传活动数据，为用户提供一个易于理解的可视化的日常活动模式。目标设定功能与简单的图形和图表一起使用，以增强能量平衡的自我监控。参与者将被赋予一个体育活动目标，接受使用自我监测网站的培训，并被要求在16周内每天将FitBit夹在衣服上。主要终点将是在随机分组前和16周时通过ActiGraph GT3X加速度计测量的met小时/天的身体活动变化。虽然这是一项初步研究，但在p<0.10的显著性水平下，我们将有80%的能力观察到0.7的效应量。调查问卷将用于衡量干预的可接受性，直接数据下载将提供对使用模式的客观评估。癌症相关性：促进体重管理和身体活动是预防乳腺癌的一个重要方面，因为过度肥胖与绝经后乳腺癌的风险增加有关。随着干预研究的发展，技术为癌症预防研究人员提供了从昂贵的传统干预转向易于传播的干预的可能性，这些干预可以在研究结束后继续进行。

DESCRIPTION (provided by applicant): Obesity (i.e., excess energy intake and inadequate physical inactivity) is associated with increased risk of breast cancer among postmenopausal women. Effective and practical intervention strategies are needed to address the high prevalence of excess weight and sedentary lifestyle in middle-aged and older US women. Although web-based interventions to promote a healthy lifestyle are common, no studies have tested the use of web-integrated physical activity meters for promoting behavior change in this population. By leveraging innovative technology-based approaches, researchers and physicians may be able to replace intensive physical activity interventions with low-cost alternatives. OBJECTIVE: To test the feasibility of using a web- based self-monitoring technology (the FitBit) to promote physical activity among women at elevated risk for breast cancer (i.e., overweight/obese, inactive postmenopausal women). SPECIFIC AIMS: This pilot study proposes to use a 16-week randomized controlled trial of a novel intervention (FitBit activity monitor + training) vs. a pedometer to address the following aims: Primary aim: To investigate the effect of the FitBit-based intervention vs. provision of a pedometer on objective measures of physical activity and sedentary behavior. Secondary aim: To examine the acceptability and usage patterns of the device and website. METHODS: Fifty participants will be randomly assigned to receive (a) a FitBit monitor and training on use of the website or (b) a pedometer. The FitBit is a tiny physical activity tracking device that pairs with a website, wirelessly uploading activity data to provide the user with an easy-to-understand visualization of her daily activity patterns. Goal-setting features are used alongside simple graphs and charts to enhance self-monitoring of energy balance. Participants will be given a physical activity goal, trained in the use of the self-monitoring website, and asked to wear the FitBit clipped to their clothing every day for 16 weeks. The primary outcome will be change in MET-hours/day of physical activity, as measured by the ActiGraph GT3X accelerometer prior to randomization and at 16 weeks. Although this is a pilot study, we will have 80% power to observe an effect size of 0.7 at a significance level of p<0.10. Questionnaires will be used to measure intervention acceptability and direct data downloads will provide an objective assessment of usage patterns. CANCER RELEVANCE: Promotion of weight management and physical activity is an important aspect of breast cancer prevention because excess adiposity is associated with increased risk of post-menopausal breast cancer. As intervention research evolves, technology offers the potential for cancer prevention researchers to move away from costly traditional interventions toward easily disseminated interventions that can continue after the study has ended.