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

描述（由申请人提供）：肥胖（即，能量摄入过多和缺乏身体活动）与绝经后妇女患乳腺癌的风险增加有关。需要有效和实用的干预策略，以解决中年和老年美国妇女超重和久坐不动的生活方式的高患病率。虽然基于网络的干预措施，以促进健康的生活方式是常见的，没有研究已经测试了使用网络集成的身体活动米，以促进在这一人群的行为改变。通过利用创新的技术方法，研究人员和医生可以用低成本的替代品取代密集的体力活动干预。目的：为了测试使用基于网络的自我监测技术（FitBit）来促进乳腺癌风险升高的女性（即，超重/肥胖、不活动的绝经后妇女）。具体目标：这项试点研究建议使用一项为期16周的随机对照试验，对一种新的干预措施（FitBit活动监测器+训练）与计步器进行比较，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：检查器械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监测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，与网站配对，无线上传活动数据，为用户提供易于理解的日常活动模式可视化。目标设定功能与简单的图表一起使用，以增强对能量平衡的自我监测。参与者将获得一个身体活动目标，接受使用自我监测网站的培训，并要求每天佩戴夹在衣服上的FitBit，持续16周。主要结局将是在随机化前和第16周时通过ActiGraph GT 3X加速计测量的MET-小时/天体力活动的变化。虽然这是一项初步研究，但我们将有80%的把握度在p<0.10的显著性水平下观察到0.7的效应量。将使用问卷来衡量干预措施的可接受性，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措施转向易于传播的干预措施的可能性，这些干预措施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.