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
About this trial
This is an interventional health services research trial for Hypertension focused on measuring Biosensors, Virtual Reality, Dietary Sodium
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
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
NCT ID
NCT03027791
First Posted
December 23, 2016
Last Updated
January 19, 2017
Sponsor
Cedars-Sinai Medical Center
Collaborators
Hearst Foundations
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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Sodium Healthy Living Project
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