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测试活动监测器对健康的影响:一项针对老年初级保健患者的随机对照试验研究方案。

Testing Activity Monitors' Effect on Health: Study Protocol for a Randomized Controlled Trial Among Older Primary Care Patients.

作者信息

Lewis Zakkoyya H, Ottenbacher Kenneth J, Fisher Steve R, Jennings Kristofer, Brown Arleen F, Swartz Maria C, Lyons Elizabeth J

机构信息

University of Texas Medical Branch, Division of Rehabilitation Sciences, Galveston, TX, United States.

出版信息

JMIR Res Protoc. 2016 Apr 29;5(2):e59. doi: 10.2196/resprot.5454.

Abstract

BACKGROUND

Cardiovascular disease is the leading cause of mortality in the United States. Maintaining healthy levels of physical activity is critical to cardiovascular health, but many older adults are inactive. There is a growing body of evidence linking low motivation and inactivity. Standard behavioral counseling techniques used within the primary care setting strive to increase motivation, but often do not emphasize the key component of self-control. The addition of electronic activity monitors (EAMs) to counseling protocols may provide more effective behavior change and increase overall motivation for exercise through interactive self-monitoring, feedback, and social support from other users.

OBJECTIVE

The objective of the study is to conduct a three month intervention trial that will test the feasibility of adding an EAM system to brief counseling within a primary care setting. Participants (n=40) will be randomized to receive evidence-based brief counseling plus either an EAM or a pedometer.

METHODS

Throughout the intervention, we will test its feasibility and acceptability, the change in primary outcomes (cardiovascular risk and physical activity), and the change in secondary outcomes (adherence, weight and body composition, health status, motivation, physical function, psychological feelings, and self-regulation). Upon completion of the intervention, we will also conduct focus groups with the participants and with primary care stakeholders.

RESULTS

The study started recruitment in October 2015 and is scheduled to be completed by October 2016.

CONCLUSIONS

This project will lay the groundwork and establish the infrastructure for intervention refinement and ultimately translation within the primary care setting in order to prevent cardiovascular disease on a population level.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02554435; https://clinicaltrials.gov/ct2/show/NCT02554435 (Archived by WebCite at http://www.webcitation/6fUlW5tdT).

摘要

背景

心血管疾病是美国的主要死因。保持健康的身体活动水平对心血管健康至关重要,但许多老年人缺乏运动。越来越多的证据表明低动机与缺乏运动有关。初级保健机构中使用的标准行为咨询技术致力于提高动机,但往往不强调自我控制这一关键要素。在咨询方案中增加电子活动监测器(EAM)可能会带来更有效的行为改变,并通过交互式自我监测、反馈以及其他用户的社会支持来提高总体运动动机。

目的

本研究的目的是进行一项为期三个月的干预试验,以测试在初级保健机构中将EAM系统添加到简短咨询中的可行性。参与者(n = 40)将被随机分组,分别接受循证简短咨询加EAM或计步器。

方法

在整个干预过程中,我们将测试其可行性和可接受性、主要结局(心血管风险和身体活动)的变化以及次要结局(依从性、体重和身体成分、健康状况、动机、身体功能、心理感受和自我调节)的变化。干预结束后,我们还将与参与者和初级保健利益相关者进行焦点小组讨论。

结果

该研究于2015年10月开始招募,计划于2016年10月完成。

结论

该项目将为在初级保健机构中完善干预措施并最终将其转化为实际应用奠定基础并建立基础设施,以便在人群层面预防心血管疾病。

试验注册

ClinicalTrials.gov NCT02554435;https://clinicaltrials.gov/ct2/show/NCT02554435(由WebCite存档于http://www.webcitation/6fUlW5tdT)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e85a/4867768/4a96466600ab/resprot_v5i2e59_fig1.jpg

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