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Sodium Healthy Living Project (SoHELP)

2017年1月19日 更新者:Bernice Coleman, PhD, ACNP、Cedars-Sinai Medical Center
Subjects will participate in a 12-week church-based intervention with five separate components: 1) participation in weekly group sessions; 2) daily use of Fitbit activity tracker; 3) daily, twice a day blood pressure monitoring; 4) daily online food tracking; and 5) daily use of VR at home (starting at week 6). Participants will also receive phone contacts from nurse coaches (twice a week during the first 4 weeks, then once a week for the remaining 8 weeks), who will answer questions and provide support.

研究概览

详细说明

Group sessions will be held weekly for a total of 12 sessions, with each session lasting approximately 90 minutes. Given that this is a church-based study, all group sessions will begin with a prayer, and spiritual messages will be woven into the study educational materials.

Study subjects will be asked to wear a Fitbit Flex 2 activity tracker during the 12 weeks of study participation during their waking and sleeping hours. A brief training on how to operate the Fitbit will occur during the first study session, and participants will be provided with the contact information of nurse coaches for troubleshooting purposes. Participants will have the option of keeping the Fitbit Flex 2 for their personal use after the study is complete.

Participants will receive a blood pressure cuff and will be asked to record their blood pressure measurements twice a day (upon awakening and before bed) during the 12 weeks of study participation. A brief training on how to correctly take and record blood pressure measurements will take place during the first study session, and participants will be provided with the contact information of nurse coaches for troubleshooting purposes. Participants will have the option of keeping the blood pressure monitor for their personal use after the study is complete.

During the first study session, participants will be introduced to a website in which they will be asked to log all meals daily during the 12 weeks of study participation. Instructions on how to use this website will be provided during the first study session, and participants will be provided with the contact information of nurse coaches for troubleshooting purposes.

Beginning at week 6, the VR component of the intervention will be introduced. Participants will be provided with Homido Mini Virtual Reality goggles, and they will be given instructions on how to operate the VR technology using their own phones. Participants will be asked to download a VR application to their personal phones, which will only be available for participants in the research study. The research team will help participants manually download the app into their phones. Participants will be asked to use the VR daily, and to keep a daily log of which experiences they used on each day and for how long. Participants will have the option of keeping the VR goggles for their personal use after the study is complete.

Phone contacts will be initiated by nurse coaches based on time preferences expressed by participants. These contacts will provide opportunities for participants to share their blood pressure measurements, ask questions and discuss their progress and challenges. During the first 4 weeks of the pilot, these contacts will occur twice a week, and then weekly for the remaining of the pilot. The nurse coaches will provide their contact information in case that participants desire to contact them with questions at other times.

To identify study participants, the Pastor of Holman Methodist Church will make an announcement about the study during his weekly service and direct interested people to members of the research team for more information. Additionally, study flyers with contact information for the research team will be posted throughout the church.

研究类型

介入性

注册 (预期的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

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 85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:

  1. Parishioners or attendee of Holman Church who volunteer to participate
  2. Smartphone with internet access
  3. No physical disability that would inhibit full range of motion
  4. Age between 18 and 85 years
  5. Women who are not pregnant
  6. Able to provide informed consent

Exclusion Criteria:

  1. Owner of cellular or mobile phone without internet access
  2. Physical ailment(s) that would inhibit full range of motion
  3. Age less than 18 years or greater than 85 years
  4. Pregnant women
  5. Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software via self-report
  6. Sensitivity to flashing light or motion
  7. Recent stroke via self-report
  8. Injury to the eyes or face that prevents comfortable use of VR hardware or software, or safe use of the hardware (e.g., open sores, wounds, or skin rash on face)
  9. Unable to place fitbit device on wrist
  10. Unable to provide informed consent

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:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 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:Parishoners at HUMC
African-American adults aged 18-85 who attend services at Holman United Methodist Church will be exposed to Group Sessions for 12 weeks and Virtual Reality for 6 weeks.
Participation in Virtual Reality experiences focused on a) education about the effects of high sodium foods on coronary arteries, blood pressure, the kidneys, and the cerebral vasculature, and b) stress management.
12 weekly group sessions that will provide education on topics related to hypertension, dietary sodium, physical activity and stress.

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
Blood pressure
大体时间:Daily, up to 12 weeks
Twice daily blood pressure measurements
Daily, up to 12 weeks

次要结果测量

结果测量
措施说明
大体时间
Physical activity
大体时间:Daily, up to 12 weeks
Minutes active in a day as calculated by Fitbit Flex 2.
Daily, up to 12 weeks
Dietary sodium
大体时间:Daily, up to 12 weeks
Self-reported amount of dietary sodium in diet.
Daily, up to 12 weeks
Virtual Reality use
大体时间:6 weeks
Self-reported at-home virtual reality use.
6 weeks
Participant satisfaction
大体时间:12 weeks
Self-reported satisfaction with study participation.
12 weeks

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。

合作者

调查人员

  • 首席研究员:Bernice Coleman, PhD, ACNP、Cedars-Sinai Medical Center

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。

一般刊物

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

2017年1月1日

初级完成 (预期的)

2017年6月1日

研究完成 (预期的)

2017年6月1日

研究注册日期

首次提交

2016年12月23日

首先提交符合 QC 标准的

2017年1月19日

首次发布 (估计)

2017年1月23日

研究记录更新

最后更新发布 (估计)

2017年1月23日

上次提交的符合 QC 标准的更新

2017年1月19日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Pro00046886

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

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