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Sodium Healthy Living Project (SoHELP)

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality
Group Sessions
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypertension focused on measuring Biosensors, Virtual Reality, Dietary Sodium

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Parishoners at HUMC

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Blood pressure
    Twice daily blood pressure measurements

    Secondary Outcome Measures

    Physical activity
    Minutes active in a day as calculated by Fitbit Flex 2.
    Dietary sodium
    Self-reported amount of dietary sodium in diet.
    Virtual Reality use
    Self-reported at-home virtual reality use.
    Participant satisfaction
    Self-reported satisfaction with study participation.

    Full Information

    First Posted
    December 23, 2016
    Last Updated
    January 19, 2017
    Sponsor
    Cedars-Sinai Medical Center
    Collaborators
    Hearst Foundations
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03027791
    Brief Title
    Sodium Healthy Living Project
    Acronym
    SoHELP
    Official Title
    Sodium Healthy Living Project
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    June 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cedars-Sinai Medical Center
    Collaborators
    Hearst Foundations

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension
    Keywords
    Biosensors, Virtual Reality, Dietary Sodium

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Parishoners at HUMC
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Virtual Reality
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Group Sessions
    Intervention Description
    12 weekly group sessions that will provide education on topics related to hypertension, dietary sodium, physical activity and stress.
    Primary Outcome Measure Information:
    Title
    Blood pressure
    Description
    Twice daily blood pressure measurements
    Time Frame
    Daily, up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Physical activity
    Description
    Minutes active in a day as calculated by Fitbit Flex 2.
    Time Frame
    Daily, up to 12 weeks
    Title
    Dietary sodium
    Description
    Self-reported amount of dietary sodium in diet.
    Time Frame
    Daily, up to 12 weeks
    Title
    Virtual Reality use
    Description
    Self-reported at-home virtual reality use.
    Time Frame
    6 weeks
    Title
    Participant satisfaction
    Description
    Self-reported satisfaction with study participation.
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bernice Coleman, PhD, ACNP
    Phone
    310-423-6178
    Email
    Bernice.Coleman@cshs.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bibiana Martinez, MPH
    Phone
    310-423-6238
    Email
    bibiana.martinez@cshs.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bernice Coleman, PhD, ACNP
    Organizational Affiliation
    Cedars-Sinai Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26374480
    Citation
    Brown DL, Conley KM, Sanchez BN, Resnicow K, Cowdery JE, Sais E, Murphy J, Skolarus LE, Lisabeth LD, Morgenstern LB. A Multicomponent Behavioral Intervention to Reduce Stroke Risk Factor Behaviors: The Stroke Health and Risk Education Cluster-Randomized Controlled Trial. Stroke. 2015 Oct;46(10):2861-7. doi: 10.1161/STROKEAHA.115.010678. Epub 2015 Sep 15.
    Results Reference
    background
    PubMed Identifier
    26674992
    Citation
    Schoenthaler A, Lancaster K, Midberry S, Nulty M, Ige E, Palfrey A, Kumar N, Ogedegbe G. The FAITH Trial: Baseline Characteristics of a Church-based Trial to Improve Blood Pressure Control in Blacks. Ethn Dis. 2015 Aug 7;25(3):337-44. doi: 10.18865/ed.25.3.337.
    Results Reference
    background
    PubMed Identifier
    12709466
    Citation
    Appel LJ, Champagne CM, Harsha DW, Cooper LS, Obarzanek E, Elmer PJ, Stevens VJ, Vollmer WM, Lin PH, Svetkey LP, Stedman SW, Young DR; Writing Group of the PREMIER Collaborative Research Group. Effects of comprehensive lifestyle modification on blood pressure control: main results of the PREMIER clinical trial. JAMA. 2003 Apr 23-30;289(16):2083-93. doi: 10.1001/jama.289.16.2083.
    Results Reference
    background
    PubMed Identifier
    25461496
    Citation
    Yeary KH, Cornell CE, Prewitt E, Bursac Z, Tilford JM, Turner J, Eddings K, Love S, Whittington E, Harris K. The WORD (Wholeness, Oneness, Righteousness, Deliverance): design of a randomized controlled trial testing the effectiveness of an evidence-based weight loss and maintenance intervention translated for a faith-based, rural, African American population using a community-based participatory approach. Contemp Clin Trials. 2015 Jan;40:63-73. doi: 10.1016/j.cct.2014.11.009. Epub 2014 Nov 15.
    Results Reference
    background
    PubMed Identifier
    24576512
    Citation
    Lancaster KJ, Schoenthaler AM, Midberry SA, Watts SO, Nulty MR, Cole HV, Ige E, Chaplin W, Ogedegbe G. Rationale and design of Faith-based Approaches in the Treatment of Hypertension (FAITH), a lifestyle intervention targeting blood pressure control among black church members. Am Heart J. 2014 Mar;167(3):301-7. doi: 10.1016/j.ahj.2013.10.026. Epub 2013 Nov 6.
    Results Reference
    background
    PubMed Identifier
    15917045
    Citation
    Kumanyika SK, Shults J, Fassbender J, Whitt MC, Brake V, Kallan MJ, Iqbal N, Bowman MA. Outpatient weight management in African-Americans: the Healthy Eating and Lifestyle Program (HELP) study. Prev Med. 2005 Aug;41(2):488-502. doi: 10.1016/j.ypmed.2004.09.049. Erratum In: Prev Med. 2006 May;42(5):397.
    Results Reference
    background
    PubMed Identifier
    11574336
    Citation
    Resnicow K, Jackson A, Wang T, De AK, McCarty F, Dudley WN, Baranowski T. A motivational interviewing intervention to increase fruit and vegetable intake through Black churches: results of the Eat for Life trial. Am J Public Health. 2001 Oct;91(10):1686-93. doi: 10.2105/ajph.91.10.1686.
    Results Reference
    background
    PubMed Identifier
    24985320
    Citation
    Walker J, Ainsworth B, Hooker S, Keller C, Fleury J, Chisum J, Swan P. Optimal Health (Spirit, Mind, and Body): A Feasibility Study Promoting Well-Being for Health Behavior Change. J Relig Health. 2015 Oct;54(5):1681-98. doi: 10.1007/s10943-014-9890-7.
    Results Reference
    background
    PubMed Identifier
    26541338
    Citation
    Schwingel A, Galvez P. Divine Interventions: Faith-Based Approaches to Health Promotion Programs for Latinos. J Relig Health. 2016 Dec;55(6):1891-906. doi: 10.1007/s10943-015-0156-9.
    Results Reference
    background
    PubMed Identifier
    25196412
    Citation
    Lancaster KJ, Carter-Edwards L, Grilo S, Shen C, Schoenthaler AM. Obesity interventions in African American faith-based organizations: a systematic review. Obes Rev. 2014 Oct;15 Suppl 4:159-76. doi: 10.1111/obr.12207.
    Results Reference
    background
    PubMed Identifier
    18306238
    Citation
    Horowitz CR, Goldfinger JZ, Muller SE, Pulichino RS, Vance TL, Arniella G, Lancaster KJ. A model for using community-based participatory research to address the diabetes epidemic in East Harlem. Mt Sinai J Med. 2008 Jan-Feb;75(1):13-21. doi: 10.1002/msj.20017.
    Results Reference
    background
    PubMed Identifier
    20691523
    Citation
    Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13.
    Results Reference
    background
    PubMed Identifier
    25972074
    Citation
    Hua Y, Qiu R, Yao WY, Zhang Q, Chen XL. The Effect of Virtual Reality Distraction on Pain Relief During Dressing Changes in Children with Chronic Wounds on Lower Limbs. Pain Manag Nurs. 2015 Oct;16(5):685-91. doi: 10.1016/j.pmn.2015.03.001. Epub 2015 May 9.
    Results Reference
    background
    PubMed Identifier
    18559702
    Citation
    Chen X, Wang Y. Tracking of blood pressure from childhood to adulthood: a systematic review and meta-regression analysis. Circulation. 2008 Jun 24;117(25):3171-80. doi: 10.1161/CIRCULATIONAHA.107.730366. Epub 2008 Jun 16.
    Results Reference
    background
    PubMed Identifier
    17691874
    Citation
    Atkinson NL. Developing a questionnaire to measure perceived attributes of eHealth innovations. Am J Health Behav. 2007 Nov-Dec;31(6):612-21. doi: 10.5555/ajhb.2007.31.6.612.
    Results Reference
    background
    Links:
    URL
    http://www.cdc.gov/nchs/nhis/SHS/tables.htm.
    Description
    Tables of Summary Health Statistics for U.S. Adults: 2015 National Health Interview Survey. National Center for Health Statistics
    URL
    https://millionhearts.hhs.gov/files/MH_YearinReview_2012.pdf
    Description
    Building Strong Partnerships for Progress, 2012. U.S. Department of Health and Human Services

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