面向农村男性的远程锻炼计划
评估针对农村社区不活跃男性的远程体育活动计划的可行性研究
The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a remote physical activity intervention designed for rural inactive men.
研究概览
地位
条件
详细说明
The proposed study is a pilot randomized controlled trial that will randomize participants to either 1) Immediate intervention, which consists of a 12-week physical activity program or 2) Delayed Intervention, which participants will be assigned to a 6-week abridged version of the program at the end of 12 weeks. Both versions of the physical activity program will provide participants a platform to report their exercise weekly, behavioral lessons, and receive personalized feedback on activity levels. The primary endpoint is to examine the feasibility and acceptability of the 12-week program by evaluating recruitment and retention rates, completion of phone calls, adherence to physical activity self-monitoring, and program satisfaction at 12-weeks. Preliminary efficacy will be assessed by changes in moderate-vigorous physical activity (MVPA), steps/day, health-related quality of life, self-efficacy, self-regulation, and supportive accountability at the end of 12-weeks.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
South Carolina
-
Columbia、South Carolina、美国、29208
- University of South Carolina
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Identify biological sex as male
- Engage in less than 90 minutes of self-reported moderate intensity exercise
- Ability to read and write in English
- Primarily living in a rural jurisdiction defined by 1 of the 7 more widely used definitions of rurality by the United States government
- Ability to walk independently for at least one block
Exclusion Criteria:
- Have a medical condition that could be made worse with a change in physical activity
- Plans to relocate from primary residence within 3 months of signing up for study
- Not willing to wear physical activity monitor for 7 days or complete surveys
- Less than 4 valid days of activity monitor wear time at baseline assessment
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Immediate
Receive intervention immediately after randomization |
Participants will receive a 12 week remotely delivered physical activity program immediately after randomization. Participants will receive bi-weekly calls, behavioral lessons, and bi-weekly behavioral feedback via email. |
|
其他：Delayed
Start intervention after 12 week assessment |
Participants receive a 6 week remote physical activity program after completing the 12 week assessment. The program includes weekly calls, behavioral lessons, and weekly behavioral feedback via email. |
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 recruitment
大体时间：12 weeks
|
Percentage of recruitment rate (screened/enrolled) |
12 weeks
|
|
Retention
大体时间：12 weeks
|
Percentage of participants who complete the study |
12 weeks
|
|
Adherence to coaching calls
大体时间：12 weeks
|
Percentage of coaching calls completed in Immediate condition |
12 weeks
|
|
Adherence to self-monitoring
大体时间：12 weeks
|
Percentage of self-monitoring logs submitted in Immediate condition |
12 weeks
|
|
Acceptability
大体时间：12 weeks
|
Program satisfaction with the 12 week remote program in Immediate condition |
12 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical activity - Moderate to vigorous minutes/week
大体时间：baseline to 12 weeks
|
Moderate-vigorous intensity physical activity (minutes/week) assessed by activPAL |
baseline to 12 weeks
|
|
Physical activity - Steps
大体时间：baseline to 12 weeks
|
Steps/day assessed by activPAL |
baseline to 12 weeks
|
|
Global Health
大体时间：baseline to 12 weeks
|
Global Health assessed via PROMIS (t-score) |
baseline to 12 weeks
|
合作者和调查者
调查人员
- 研究主任：Christine A Pellegrini, PhD、University of South Carolina
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
IPD will be shared on request to the PI
IPD 共享时间框架
IPD will be available on request after outcomes have been published
IPD 共享访问标准
IPD will be available on request after outcomes have been published
IPD 共享支持信息类型
- 研究方案
- 国际碳纤维联合会
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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