Exercise Promotion in Primary Care (EPPC)
2021年8月30日 更新者：Deborah R. Young、Kaiser Permanente
Exercise Promotion in Primary Care: Pilot Study
The investigators conducted a pilot study to determine if telephone counseling, in a health care setting that routinely assesses physical activity of its members, is a feasible approach to improve physical activity among patients with diabetes and prediabetes.
The investigators built on an existing innovation at Kaiser Permanente, in which physical activity is assessed at every outpatient visit.
The primary aims were to (1) pilot study elements, including database identification of patients; recruitment, training and engagement of health care providers; patient recruitment; data collection procedures; and a 24-week intervention, and (2) to assess feasibility and obtain feedback from key stakeholders on the approach.
研究概览
研究类型
介入性
注册 (实际的)
67
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 74年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- prediabetes or diabetes not prescribed insulin
- less than 30 min of physical activity per week
- cleared to increase physical activity by primary care provider
Exclusion Criteria:
- health condition that may limit unsupervised physical activity
- height and weight that were combined and resulted in a BMI > 40 kg/m2
- disabling rheumatoid or osteoarthritis
- ongoing treatment for cancer
- unstable coronary heart disease
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Telephone counseling
Participants were provided with approximately 7 telephone-based motivational interviewing over a 24-week period to increase their physical activity.
|
|
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无干预：Usual care
Participants in the usual care arm received a packet of places near their home in which they could engage in physical activity if they chose.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Feasibility of identifying and recruiting sufficient number of participants into a telephone-based physical activity intervention.
大体时间：The intervention lasted 24 weeks.
|
Participants who met eligibility criteria and who were scheduled for an outpatient visit with their primary care provider were invited to participate in the study.
Feasibility was assessed by the investigators' ability to recruit 60 participants into the pilot trial.
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The intervention lasted 24 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Moderate to Vigorous Physical Activity
大体时间：Assessments were made a baseline and approximately 24 weeks after baseline assessments.
|
Participants were mailed an Actigraph model 7185 accelerometer and asked to wear it over their right hip for 7 consecutive days and return the monitor through the mail.
Data were analyzed to assess daily moderate to vigorous physical activity using the Freedson cutpoints.
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Assessments were made a baseline and approximately 24 weeks after baseline assessments.
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Motivation for Physical Activity
大体时间：Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
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The 30-item Motivation for Physical Activities Measure was used to measure motivation for physical activity.
The scale has 5 factors: interest/enjoyment, competence, appearance, fitness, and social motivations.
A mean score for each factor was determined for each participant.
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Participants completed the survey at baseline and approximately 24 weeks after baseline assessments.
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Physical Activity Self-Regulation
大体时间：Participants completed the survey at baseline and approximately 24 weeks after baseline.
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This is a 16-item scale with the following factors: external regulation, introjected regulation, identified regulation, and intrinsic regulation.
A Relative Autonomy Index is formed from the factors, with the higher scores indicating greater autonomy toward physical activity.
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Participants completed the survey at baseline and approximately 24 weeks after baseline.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年6月1日
初级完成 (实际的)
2017年7月1日
研究完成 (实际的)
2017年7月1日
研究注册日期
首次提交
2018年1月31日
首先提交符合 QC 标准的
2018年2月5日
首次发布 (实际的)
2018年2月12日
研究记录更新
最后更新发布 (实际的)
2021年9月1日
上次提交的符合 QC 标准的更新
2021年8月30日
最后验证
2018年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.