Sodium Healthy Living Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sodium Healthy Living Project

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Virtual Reality
* Behavioral: Group Sessions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parishioners or attendee of Holman Church who volunteer to participate Smartphone with internet access No physical disability that would inhibit full range of motion Age between 18 and 85 years Women who are not pregnant Able to provide informed consent Exclusion Criteria: Owner of cellular or mobile phone without internet access Physical ailment(s) that would inhibit full range of motion Age less than 18 years or greater than 85 years Pregnant women Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware and software via self-report Sensitivity to flashing light or motion Recent stroke via self-report 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) Unable to place fitbit device on wrist Unable to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Parishoners at HUMC<br>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. | Behavioral: Virtual Reality<br>* 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.<br>Behavioral: Group Sessions<br>* 12 weekly group sessions that will provide education on topics related to hypertension, dietary sodium, physical activity and stress.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Twice daily blood pressure measurements | Daily, up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Minutes active in a day as calculated by Fitbit Flex 2. | Daily, up to 12 weeks | 
| Dietary sodium | Self-reported amount of dietary sodium in diet. | Daily, up to 12 weeks | 
| Virtual Reality use | Self-reported at-home virtual reality use. | 6 weeks | 
| Participant satisfaction | Self-reported satisfaction with study participation. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biosensors, Virtual Reality, Dietary Sodium