<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/NCT02214459</url>
  </required_header>
  <id_info>
    <org_study_id>H-32775</org_study_id>
    <nct_id>NCT02214459</nct_id>
  </id_info>
  <brief_title>Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot</brief_title>
  <acronym>DASH Mobile</acronym>
  <official_title>Dietary Approaches to Stopping Hypertension (DASH) Mobile App Pilot</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk&#xD;
      interventions. The DASH program of diet and exercise based lifestyle change is the most&#xD;
      well-established, evidence-based behavioral intervention to control HTN. Its recommendations&#xD;
      are central to HTN control national guidelines and consumer health products aimed at&#xD;
      behavioral management of HTN. However, translating these recommendations into&#xD;
      population-wide, inexpensive, sustainable programs have to date proven largely unrealized.&#xD;
      The objective of the proposed study is to determine the efficacy of a HTN intervention&#xD;
      behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about&#xD;
      the DASH diet, physical activity and HTN related behaviors from health coaches trained in&#xD;
      evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a&#xD;
      smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH&#xD;
      diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity&#xD;
      and 2) a web-based coaching portal through which health coaches view and respond to patients'&#xD;
      behavioral data and assist them in setting goals for changing behaviors consistent with their&#xD;
      HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine&#xD;
      improvement from baseline to 3-month follow-up in physiological (blood pressure, weight);&#xD;
      behavioral (diet &amp; physical activity); and psychological (e.g., quality of life) measures&#xD;
      over a 3-month intervention. Completing this research will result in preliminary feasibility&#xD;
      and efficacy data for a larger randomized efficacy trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood pressure reduction</measure>
    <time_frame>3 Months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>mhealth counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DASH Mobile mhealth enhanced coaching</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DASH Mobile mhealth enhanced coaching</intervention_name>
    <description>Phone calls with a health coach that utilize the tracking data collected by the app and devices.</description>
    <arm_group_label>mhealth counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hypertension&#xD;
&#xD;
          -  prehypertension&#xD;
&#xD;
          -  smartphone&#xD;
&#xD;
          -  english speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  on more than 1 medicine for hypertension&#xD;
&#xD;
          -  live outside Boston metro area&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>March 21, 2017</last_update_submitted>
  <last_update_submitted_qc>March 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mHealth</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Mobile</keyword>
  <keyword>smartphone</keyword>
  <keyword>diet</keyword>
  <keyword>lifestyle</keyword>
  <keyword>bluetooth</keyword>
  <keyword>physical acitvity</keyword>
  <keyword>behavior change</keyword>
  <keyword>motivational interviewing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT02214459
org study id: H-32775
nct id: NCT02214459
lead sponsor: 
has dmc: No
The enormous burden of hypertension (HTN) creates a need for effective, scalable, low risk
      interventions. The DASH program of diet and exercise based lifestyle change is the most
      well-established, evidence-based behavioral intervention to control HTN. Its recommendations
      are central to HTN control national guidelines and consumer health products aimed at
      behavioral management of HTN. However, translating these recommendations into
      population-wide, inexpensive, sustainable programs have to date proven largely unrealized.
      The objective of the proposed study is to determine the efficacy of a HTN intervention
      behavior change platform, 'DASH Mobile', in which patients with HTN receive counseling about
      the DASH diet, physical activity and HTN related behaviors from health coaches trained in
      evidenced-based behavioral counseling methods. DASH mobile has two primary components: 1) a
      smartphone app that captures patients' behavioral data using intuitive self-tracking for DASH
      diet intake and Bluetooth wireless sensors for blood pressure, weight and physical activity
      and 2) a web-based coaching portal through which health coaches view and respond to patients'
      behavioral data and assist them in setting goals for changing behaviors consistent with their
      HTN behavior change plan. We aim to conduct a pilot trial of 30 HTN patients to determine
      improvement from baseline to 3-month follow-up in physiological (blood pressure, weight);
      behavioral (diet & physical activity); and psychological (e.g., quality of life) measures
      over a 3-month intervention. Completing this research will result in preliminary feasibility
      and efficacy data for a larger randomized efficacy trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Blood pressure reduction
time frame: 3 Months
arm group label: mhealth counseling
arm group type: Experimental
description: DASH Mobile mhealth enhanced coaching
intervention type: Behavioral
intervention name: DASH Mobile mhealth enhanced coaching
description: Phone calls with a health coach that utilize the tracking data collected by the app and devices.
arm group label: mhealth counseling
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hypertension