Activity Prescription in Clinical Practice
追踪信息 | |||
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首次提交日期 ICMJE | September 28, 2018 | ||
首次发布日期e ICMJE | October 3, 2018 | ||
最后更新发布日期 | October 3, 2018 | ||
预计研究开始日期 ICMJE | October 2018 | ||
预计主要完成日期 | July 31, 2019 (主要结果测量的最终数据收集日期) | ||
目前主要观察指标 ICMJE |
Change in Aerobic activity[ Time Frame: 10 days of recording at 0 and 3 months ] Objectively measured change in moderate-vigorous activity between 0 and 3 months using ActiGraph accelerometer Change in Step counts[ Time Frame: 10 days of recording at 0 and 3 months ] Objectively measured change in step counts between 0 and 3 months using ActiGraph accelerometer Change in sedentary behavior[ Time Frame: 10 days of recording at 0 and 3 months ] Objectively measured change in sedentary behavior between 0 and 3 months using ActiGraph accelerometer |
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原始主要观察测量 ICMJE | 与当前相同 | ||
目前的二级观察 ICMJE |
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描述性信息 | |||
简略标题 ICMJE | Activity Prescription in Clinical Practice | ||
正式标题 ICMJE | Advancement of Physical Activity Prescription in Clinical Practice | ||
简要概况 | Most adults do not achieve the US aerobic physical activity (PA) guidelines (≥150 minutes/week of at least moderate intensity PA). Inadequate PA is considered a major risk factor for cardio-metabolic diseases and other poor health outcomes. Recommendations now endorse PA in reducing risk for certain diseases. Unfortunately, low PA levels are seldom identified and treated within clinical practice. This study will build on previous prevention efforts by focusing on the identifying and treating low PA levels in adults clinical care patients and referring them to an intervention that is feasible for delivery through clinical care. |
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详细说明 | This study involves designing/ implementing a patient-centered, individually-focused physical activity (PA) intervention designed for integration into clinical care. We will recruit adult patients (aged 21-70; n=80) from the general internal medicine practice of a local health system who are not meeting the US aerobic activity goal of 150 minutes/ week of at least moderate intensity PA and who can safely increase PA without supervision. As low PA levels have been associated with numerous poor health outcomes, the primary intervention goal will be achievement of the US PA goal. A secondary goal will be to reduce sedentary behavior (SED), which is related to poor health outcomes (independent of PA achievement). Intervention materials will be developed using a patient/provider centered approach and delivered weekly over 3 months via an existing online platform with participants self-tracking behavior outcomes will be examined using a three month wait-listed control design in which all participants will eventually receive the intervention. | ||
研究类型 ICMJE | Interventional | ||
研究阶段 | N/A | ||
研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 3 month wait-listed control trial in which participants are randomized to immediate intervention or intervention after 3 months. 盲法: Interventional 盲法描述:Participants and their referring physician will be aware of participant randomization. Only the intervention coach, who will also notify the participants of their assignment will be aware of the assignments; other study staff and the investigator will be masked. 主要目的: Prevention |
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适用条件 ICMJE | |||
干预项目 ICMJE |
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研究工具 |
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招募信息 | |||
招募状态 ICMJE | Not yet recruiting | ||
预计入组 ICMJE |
80 | ||
原始预计入组 ICMJE | 与当前相同 | ||
预计研究完成日期 | October 31, 2019 | ||
预计主要完成日期 | July 31, 2019 (主要结果测量的最终数据收集日期) | ||
合格标准 ICMJE | Inclusion Criteria: - not meeting the recommended levels of aerobic PA and have been identified by their primary care provider (PCP) as able to increase their PA without supervision. Exclusion Criteria: - Participated in a goal setting intervention for physical activity or a translation of the Diabetes Prevention Program within the last 2 years. - Non-ambulatory or planning a procedure that will cause them to be non-ambulatory in the next 6 months - Pregnant or planning a pregnancy in the next 6 months - Need a way to access to the internet-based platform, at least a 6th grade reading level. | ||
性别 |
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年龄 | 最小年龄:21 Years ,最大年龄:70 Years | ||
接受健康的志愿者 | 没有 | ||
可入组国家 ICMJE | |||
管理信息 | 数据检测委员会 | Yes | |
研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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IPD 共享声明 |
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责任方 | Bonny Rockette-Wagner,University of Pittsburgh | ||
研究赞助商 ICMJE | University of Pittsburgh | ||
合作者 ICMJE | |||
研究员 ICMJE |
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PRS 账户 | University of Pittsburgh | ||
验证日期 | October 2018 | ||
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |