<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03027791</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00046886</org_study_id>
    <nct_id>NCT03027791</nct_id>
  </id_info>
  <brief_title>Sodium Healthy Living Project</brief_title>
  <acronym>SoHELP</acronym>
  <official_title>Sodium Healthy Living Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cedars-Sinai Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hearst Foundations</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cedars-Sinai Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects will participate in a 12-week church-based intervention with five separate&#xD;
      components: 1) participation in weekly group sessions; 2) daily use of Fitbit activity&#xD;
      tracker; 3) daily, twice a day blood pressure monitoring; 4) daily online food tracking; and&#xD;
      5) daily use of VR at home (starting at week 6). Participants will also receive phone&#xD;
      contacts from nurse coaches (twice a week during the first 4 weeks, then once a week for the&#xD;
      remaining 8 weeks), who will answer questions and provide support.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Group sessions will be held weekly for a total of 12 sessions, with each session lasting&#xD;
      approximately 90 minutes. Given that this is a church-based study, all group sessions will&#xD;
      begin with a prayer, and spiritual messages will be woven into the study educational&#xD;
      materials.&#xD;
&#xD;
      Study subjects will be asked to wear a Fitbit Flex 2 activity tracker during the 12 weeks of&#xD;
      study participation during their waking and sleeping hours. A brief training on how to&#xD;
      operate the Fitbit will occur during the first study session, and participants will be&#xD;
      provided with the contact information of nurse coaches for troubleshooting purposes.&#xD;
      Participants will have the option of keeping the Fitbit Flex 2 for their personal use after&#xD;
      the study is complete.&#xD;
&#xD;
      Participants will receive a blood pressure cuff and will be asked to record their blood&#xD;
      pressure measurements twice a day (upon awakening and before bed) during the 12 weeks of&#xD;
      study participation. A brief training on how to correctly take and record blood pressure&#xD;
      measurements will take place during the first study session, and participants will be&#xD;
      provided with the contact information of nurse coaches for troubleshooting purposes.&#xD;
      Participants will have the option of keeping the blood pressure monitor for their personal&#xD;
      use after the study is complete.&#xD;
&#xD;
      During the first study session, participants will be introduced to a website in which they&#xD;
      will be asked to log all meals daily during the 12 weeks of study participation. Instructions&#xD;
      on how to use this website will be provided during the first study session, and participants&#xD;
      will be provided with the contact information of nurse coaches for troubleshooting purposes.&#xD;
&#xD;
      Beginning at week 6, the VR component of the intervention will be introduced. Participants&#xD;
      will be provided with Homido Mini Virtual Reality goggles, and they will be given&#xD;
      instructions on how to operate the VR technology using their own phones. Participants will be&#xD;
      asked to download a VR application to their personal phones, which will only be available for&#xD;
      participants in the research study. The research team will help participants manually&#xD;
      download the app into their phones. Participants will be asked to use the VR daily, and to&#xD;
      keep a daily log of which experiences they used on each day and for how long. Participants&#xD;
      will have the option of keeping the VR goggles for their personal use after the study is&#xD;
      complete.&#xD;
&#xD;
      Phone contacts will be initiated by nurse coaches based on time preferences expressed by&#xD;
      participants. These contacts will provide opportunities for participants to share their blood&#xD;
      pressure measurements, ask questions and discuss their progress and challenges. During the&#xD;
      first 4 weeks of the pilot, these contacts will occur twice a week, and then weekly for the&#xD;
      remaining of the pilot. The nurse coaches will provide their contact information in case that&#xD;
      participants desire to contact them with questions at other times.&#xD;
&#xD;
      To identify study participants, the Pastor of Holman Methodist Church will make an&#xD;
      announcement about the study during his weekly service and direct interested people to&#xD;
      members of the research team for more information. Additionally, study flyers with contact&#xD;
      information for the research team will be posted throughout the church.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2017</completion_date>
  <primary_completion_date type="Anticipated">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>Daily, up to 12 weeks</time_frame>
    <description>Twice daily blood pressure measurements</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>Daily, up to 12 weeks</time_frame>
    <description>Minutes active in a day as calculated by Fitbit Flex 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dietary sodium</measure>
    <time_frame>Daily, up to 12 weeks</time_frame>
    <description>Self-reported amount of dietary sodium in diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Virtual Reality use</measure>
    <time_frame>6 weeks</time_frame>
    <description>Self-reported at-home virtual reality use.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant satisfaction</measure>
    <time_frame>12 weeks</time_frame>
    <description>Self-reported satisfaction with study participation.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Parishoners at HUMC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Virtual Reality</intervention_name>
    <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.</description>
    <arm_group_label>Parishoners at HUMC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Sessions</intervention_name>
    <description>12 weekly group sessions that will provide education on topics related to hypertension, dietary sodium, physical activity and stress.</description>
    <arm_group_label>Parishoners at HUMC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Parishioners or attendee of Holman Church who volunteer to participate&#xD;
&#xD;
          2. Smartphone with internet access&#xD;
&#xD;
          3. No physical disability that would inhibit full range of motion&#xD;
&#xD;
          4. Age between 18 and 85 years&#xD;
&#xD;
          5. Women who are not pregnant&#xD;
&#xD;
          6. Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Owner of cellular or mobile phone without internet access&#xD;
&#xD;
          2. Physical ailment(s) that would inhibit full range of motion&#xD;
&#xD;
          3. Age less than 18 years or greater than 85 years&#xD;
&#xD;
          4. Pregnant women&#xD;
&#xD;
          5. Current diagnosis of epilepsy, dementia, or other neurological disease that may&#xD;
             prevent use of VR hardware and software via self-report&#xD;
&#xD;
          6. Sensitivity to flashing light or motion&#xD;
&#xD;
          7. Recent stroke via self-report&#xD;
&#xD;
          8. Injury to the eyes or face that prevents comfortable use of VR hardware or software,&#xD;
             or safe use of the hardware (e.g., open sores, wounds, or skin rash on face)&#xD;
&#xD;
          9. Unable to place fitbit device on wrist&#xD;
&#xD;
         10. Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bernice Coleman, PhD, ACNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cedars-Sinai Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bernice Coleman, PhD, ACNP</last_name>
    <phone>310-423-6178</phone>
    <email>Bernice.Coleman@cshs.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bibiana Martinez, MPH</last_name>
    <phone>310-423-6238</phone>
    <email>bibiana.martinez@cshs.org</email>
  </overall_contact_backup>
  <link>
    <url>http://www.cdc.gov/nchs/nhis/SHS/tables.htm.</url>
    <description>Tables of Summary Health Statistics for U.S. Adults: 2015 National Health Interview Survey. National Center for Health Statistics</description>
  </link>
  <link>
    <url>https://millionhearts.hhs.gov/files/MH_YearinReview_2012.pdf</url>
    <description>Building Strong Partnerships for Progress, 2012. U.S. Department of Health and Human Services</description>
  </link>
  <reference>
    <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.</citation>
    <PMID>26374480</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26674992</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>12709466</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25461496</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24576512</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>15917045</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>11574336</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24985320</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>26541338</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25196412</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18306238</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>20691523</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25972074</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>18559702</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>17691874</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 19, 2017</last_update_submitted>
  <last_update_submitted_qc>January 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cedars-Sinai Medical Center</investigator_affiliation>
    <investigator_full_name>Bernice Coleman, PhD, ACNP</investigator_full_name>
    <investigator_title>Nurse Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Biosensors</keyword>
  <keyword>Virtual Reality</keyword>
  <keyword>Dietary Sodium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03027791
org study id: Pro00046886
nct id: NCT03027791
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Blood pressure
time frame: Daily, up to 12 weeks
description: Twice daily blood pressure measurements
measure: Physical activity
time frame: Daily, up to 12 weeks
description: Minutes active in a day as calculated by Fitbit Flex 2.
measure: Dietary sodium
time frame: Daily, up to 12 weeks
description: Self-reported amount of dietary sodium in diet.
measure: Virtual Reality use
time frame: 6 weeks
description: Self-reported at-home virtual reality use.
measure: Participant satisfaction
time frame: 12 weeks
description: Self-reported satisfaction with study participation.
arm group label: Parishoners at HUMC
arm group type: Experimental
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: Virtual Reality
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.
arm group label: Parishoners at HUMC
intervention type: Behavioral
intervention name: Group Sessions
description: 12 weekly group sessions that will provide education on topics related to hypertension, dietary sodium, physical activity and stress.
arm group label: Parishoners at HUMC
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bernice Coleman, PhD, ACNP
role: Principal Investigator
affiliation: Cedars-Sinai Medical Center
last name: Bernice Coleman, PhD, ACNP
phone: 310-423-6178
email: Bernice.Coleman@cshs.org
last name: Bibiana Martinez, MPH
phone: 310-423-6238
email: bibiana.martinez@cshs.org
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
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.
PMID: 26374480
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.
PMID: 26674992
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.
PMID: 12709466
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.
PMID: 25461496
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.
PMID: 24576512
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.
PMID: 15917045
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.
PMID: 11574336
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.
PMID: 24985320
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.
PMID: 26541338
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responsible party type: Principal Investigator
investigator affiliation: Cedars-Sinai Medical Center
investigator full name: Bernice Coleman, PhD, ACNP
investigator title: Nurse Research Scientist
mesh term: Hypertension
sharing ipd: No