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Sodium Healthy Living Project (SoHELP)

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ClinicalTrials.gov Identifier: NCT03027791
Recruitment Status : Not yet recruiting
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
Sponsor:
Collaborator:
Hearst Foundations
Information provided by (Responsible Party):
Bernice Coleman, PhD, ACNP, Cedars-Sinai Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Virtual Reality Behavioral: Group Sessions Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Sodium Healthy Living Project
Study Start Date : January 2017
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sodium

Arm Intervention/treatment
Experimental: 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.
Behavioral: Virtual Reality
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.

Behavioral: Group Sessions
12 weekly group sessions that will provide education on topics related to hypertension, dietary sodium, physical activity and stress.




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: Daily, up to 12 weeks ]
    Twice daily blood pressure measurements


Secondary Outcome Measures :
  1. Physical activity [ Time Frame: Daily, up to 12 weeks ]
    Minutes active in a day as calculated by Fitbit Flex 2.

  2. Dietary sodium [ Time Frame: Daily, up to 12 weeks ]
    Self-reported amount of dietary sodium in diet.

  3. Virtual Reality use [ Time Frame: 6 weeks ]
    Self-reported at-home virtual reality use.

  4. Participant satisfaction [ Time Frame: 12 weeks ]
    Self-reported satisfaction with study participation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027791


Contacts
Contact: Bernice Coleman, PhD, ACNP 310-423-6178 Bernice.Coleman@cshs.org
Contact: Bibiana Martinez, MPH 310-423-6238 bibiana.martinez@cshs.org

Sponsors and Collaborators
Cedars-Sinai Medical Center
Hearst Foundations
Investigators
Principal Investigator: Bernice Coleman, PhD, ACNP Cedars-Sinai Medical Center

Additional Information:
Publications:

Responsible Party: Bernice Coleman, PhD, ACNP, Nurse Research Scientist, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03027791     History of Changes
Other Study ID Numbers: Pro00046886
First Posted: January 23, 2017    Key Record Dates
Last Update Posted: January 23, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bernice Coleman, PhD, ACNP, Cedars-Sinai Medical Center:
Biosensors
Virtual Reality
Dietary Sodium