NCT03027791

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable hypertension

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 23, 2017

Status Verified

January 1, 2017

Enrollment Period

5 months

First QC Date

December 23, 2016

Last Update Submit

January 19, 2017

Conditions

Hypertension

Keywords

BiosensorsVirtual RealityDietary Sodium

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Twice daily blood pressure measurements

    Daily, up to 12 weeks

Secondary Outcomes (4)

  • Physical activity

    Daily, up to 12 weeks

  • Dietary sodium

    Daily, up to 12 weeks

  • Virtual Reality use

    6 weeks

  • Participant satisfaction

    12 weeks

Study Arms (1)

Parishoners at HUMC

EXPERIMENTAL

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 RealityBehavioral: Group Sessions

Interventions

Virtual RealityBEHAVIORAL

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.

Parishoners at HUMC
Group SessionsBEHAVIORAL

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

Parishoners at HUMC

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (15)

  • 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.

    PMID: 26374480BACKGROUND

  • 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.

    PMID: 26674992BACKGROUND

  • 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.

    PMID: 12709466BACKGROUND

  • 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.

    PMID: 25461496BACKGROUND

  • 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.

    PMID: 24576512BACKGROUND

  • 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.

    PMID: 15917045BACKGROUND

  • 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.

    PMID: 11574336BACKGROUND

  • 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.

    PMID: 24985320BACKGROUND

  • 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.

    PMID: 26541338BACKGROUND

  • 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.

    PMID: 25196412BACKGROUND

  • 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.

    PMID: 18306238BACKGROUND

  • 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.

    PMID: 20691523BACKGROUND

  • 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.

    PMID: 25972074BACKGROUND

  • 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.

    PMID: 18559702BACKGROUND

  • 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.

    PMID: 17691874BACKGROUND

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Bernice Coleman, PhD, ACNP

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernice Coleman, PhD, ACNP

CONTACT

310-423-6178Bernice.Coleman@cshs.org

Bibiana Martinez, MPH

CONTACT

310-423-6238bibiana.martinez@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse Research Scientist

Study Record Dates

First Submitted

December 23, 2016

First Posted

January 23, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 23, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share