Hypertension Clinical Trial
Official title:
Sodium Healthy Living Project
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.
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.
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