Sodium Healthy Living Project

Hypertension Clinical Trial

— SoHELP  

Official title:

Sodium Healthy Living Project

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03027791
• Other study ID #: Pro00046886
• Status: Not yet recruiting
• Phase: N/A
• First received: December 23, 2016
• Last updated: January 19, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: January 2017
• Source: Cedars-Sinai Medical Center
• Contact: Bernice Coleman, PhD, ACNP
• Phone: 310-423-6178
• Email: Bernice.Coleman[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center	Hearst Foundations

References & Publications (15)

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. — View Citation

Atkinson NL. Developing a questionnaire to measure perceived attributes of eHealth innovations. Am J Health Behav. 2007 Nov-Dec;31(6):612-21. — View Citation

Brown DL, Conley KM, Sánchez 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. — View 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. Review. — View 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. — View 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. — View 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. Erratum in: Prev Med. 2006 May;42(5):397. — View 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. Review. — View 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. — View 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. Review. — View 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. — View 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. — View Citation

Schwingel A, Gálvez 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. — View 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. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Twice daily blood pressure measurements	Daily, up to 12 weeks
Secondary	Physical activity	Minutes active in a day as calculated by Fitbit Flex 2.	Daily, up to 12 weeks
Secondary	Dietary sodium	Self-reported amount of dietary sodium in diet.	Daily, up to 12 weeks
Secondary	Virtual Reality use	Self-reported at-home virtual reality use.	6 weeks
Secondary	Participant satisfaction	Self-reported satisfaction with study participation.	12 weeks

External Links

•   Building Strong Partnerships for Progress, 2012. U.S. Department of Health and Human Services
•   Sodium in Your Diet. May 2016. U.S. Food and Drug Administration.
•   Tables of Summary Health Statistics for U.S. Adults: 2015 National Health Interview Survey. National Center for Health Statistics