浸信会员工健康心脏研究的基本原理与设计：一项随机试验，评估在高危员工群体中，在现有健康信息网络平台上添加交互式、个性化、基于网络的生活方式干预工具的效果。
Rationale and design of the Baptist Employee Healthy Heart Study: a randomized trial assessing the efficacy of the addition of an interactive, personalized, web-based, lifestyle intervention tool to an existing health information web platform in a high-risk employee population.
作者信息
Post Janisse M, Ali Shozab S, Roberson Lara L, Aneni Ehimen C, Shaharyar Sameer, Younus Adnan, Jamal Omar, Ahmad Rameez, Aziz Muhammad A, Malik Rehan, Spatz Erica S, Feldman Theodore, Fialkow Jonathan, Veledar Emir, Cury Ricardo C, Agatston Arthur S, Nasir Khurram
机构信息
Center for Healthcare Advancement and Outcomes, Baptist Health Medical Group, 1691 Michigan Avenue Suite 500, Miami Beach, FL, 33139, USA.
University of Manchester School of Medicine, Manchester, UK.
出版信息
Trials. 2016 Jul 1;17(1):308. doi: 10.1186/s13063-016-1424-z.
BACKGROUND
Metabolic syndrome (MetS) and diabetes confer a high risk for developing subsequent cardiovascular disease (CVD). Persons with MetS constitute 24-34 % of the employee population at Baptist Health South Florida (BHSF), a self-insured healthcare organization. The Baptist Employee Healthy Heart Study (BEHHS) aims to assess the addition of a personalized, interactive, web-based, nutrition-management and lifestyle-management program to the existing health-expertise web platform available to BHSF employees in reducing and/or stabilizing CVD and lifestyle risk factors and markers of subclinical CVD.
METHODS/DESIGN: Subjects with MetS or Type II Diabetes will be recruited from an employee population at BHSF and randomized to either an intervention or a control arm. The intervention arm will be given access to a web-based personalized diet-modification and weight-modification program. The control arm will be reminded to use the standard informational health website available and accessible to all BHSF employees. Subjects will undergo coronary calcium testing, carotid intima-media thickness scans, peripheral arterial tonometry, and advanced lipid panel testing at visit 1, in addition to lifestyle and medical history questionnaires. All tests will be repeated at visits 2 and 4 with the exception of the coronary calcium test, which will only be performed at baseline and visit 4. Visit 3 will capture vitals, anthropometrics, and responses to the questionnaires only.
CONCLUSION
Results of this study will provide information on the effectiveness of personalized, web-based, lifestyle-management tools in reducing healthcare costs, promoting healthy choices, and reducing cardiovascular risk in an employee population. It will also provide information about the natural history of carotid atherosclerosis and endothelial dysfunction in asymptomatic but high-risk populations.
TRIAL REGISTRATION
ClinicalTrials.gov registry, NCT01912209 . Registered on 3 July 2013.
背景
代谢综合征（MetS）和糖尿病会增加后续发生心血管疾病（CVD）的风险。在南佛罗里达浸信会健康中心（BHSF）这个自我投保的医疗保健机构中，患有代谢综合征的人员占员工总数的24% - 34%。浸信会员工健康心脏研究（BEHHS）旨在评估在BHSF员工现有的健康专业网络平台上增加一个个性化、交互式、基于网络的营养管理和生活方式管理项目，对于降低和/或稳定心血管疾病及生活方式风险因素以及亚临床心血管疾病标志物的效果。
方法/设计：将从BHSF的员工群体中招募患有代谢综合征或II型糖尿病的受试者，并随机分为干预组或对照组。干预组将可以使用基于网络的个性化饮食调整和体重调整项目。对照组将被提醒使用所有BHSF员工都可访问的标准信息健康网站。受试者在第1次就诊时除了要填写生活方式和病史问卷外，还将接受冠状动脉钙化检测、颈动脉内膜中层厚度扫描、外周动脉张力测量和高级血脂检测。除了冠状动脉钙化检测仅在基线和第4次就诊时进行外，所有检测将在第2次和第4次就诊时重复进行。第3次就诊仅记录生命体征、人体测量数据和问卷回复。
结论
本研究结果将提供有关基于网络的个性化生活方式管理工具在降低员工群体医疗成本、促进健康选择以及降低心血管风险方面有效性的信息。它还将提供有关无症状但高危人群颈动脉粥样硬化和内皮功能障碍自然病史的信息。
试验注册
ClinicalTrials.gov注册编号，NCT01912209。于2013年7月3日注册。
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