<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/NCT01725945</url>
  </required_header>
  <id_info>
    <org_study_id>R34HL108753</org_study_id>
    <secondary_id>R34HL108753</secondary_id>
    <nct_id>NCT01725945</nct_id>
  </id_info>
  <brief_title>The DASH Diet for Adults With Uncontrolled Asthma</brief_title>
  <official_title>A Pilot Study of the DASH Diet in Not-Well-Controlled Adult Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palo Alto Medical Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Palo Alto Medical Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot&#xD;
      study aims to provide effect size estimates and justification, clinical trial and&#xD;
      intervention feasibility data, and procedural materials for a full-scale randomized&#xD;
      controlled trial that will determine the efficacy and mechanisms of action of the Dietary&#xD;
      Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven&#xD;
      cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled&#xD;
      asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot&#xD;
      study aims to provide effect size estimates and justification, clinical trial and&#xD;
      intervention feasibility data, and procedural materials for a full-scale randomized&#xD;
      controlled trial that will determine the efficacy and mechanisms of action of the Dietary&#xD;
      Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven&#xD;
      cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled&#xD;
      asthma. Eligible, consenting participants (n=90) will be randomized to receive usual care&#xD;
      alone or combined with a DASH intervention. Follow-up assessments will occur at 3 and 6&#xD;
      months. By evaluating a dietary pattern approach to improving asthma control, this study&#xD;
      could advance the evidence base for refining clinical guidelines and public health&#xD;
      recommendations regarding the role of dietary modifications in asthma management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>7-item Juniper Asthma Control Questionnaire (ACQ)</measure>
    <time_frame>6-months post-randomizaton</time_frame>
    <description>The ACQ provides a reliable, validated assessment of asthma control focusing on current impairment. Its 7 items assess the components of current asthma impairment as defined in the asthma treatment guidelines, i.e., daytime and nocturnal asthma symptoms, activity limitations, rescue medication use (excluding use to prevent exercise-induced bronchospasm), and lung function (FEV1). The ACQ is the only guideline-recommended composite measure of asthma control that includes lung function in its overall rating.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung function</measure>
    <time_frame>6-months post-randomization</time_frame>
    <description>Lung function measured by spirometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma specific Quality of Life</measure>
    <time_frame>6-months post-randomization</time_frame>
    <description>Juniper Mini Asthma Quality of Life Questionnaire (Mini-AQLQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma symptom-free and β2-agonist-free days</measure>
    <time_frame>6-months post-randomization</time_frame>
    <description>Asthma symptom-free and β2-agonist-free days will be calculated from 2-week asthma symptom diaries.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma-related health care utilization</measure>
    <time_frame>6 months pre-and post-randomization</time_frame>
    <description>Asthma-related health care utilization will be assessed through data extraction from Kaiser Permanente (KP) electronic databases for the periods of 6 months pre- and post-randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet adherence</measure>
    <time_frame>6-months post-randomization</time_frame>
    <description>Participants' adherence to the DASH diet will be assessed by multiple-pass 24-hour diet recalls for servings of fruits, vegetables, dairy products, and whole grains; increases in serum carotenoids, folate and vitamin B12; and reductions in fasting plasma lipids.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychosocial predictors of dietary change</measure>
    <time_frame>6-months post-randomization</time_frame>
    <description>Self-efficacy and social support for dietary change will be assessed using previously validated instruments.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comorbidities</measure>
    <time_frame>6-months post-randomization</time_frame>
    <description>Sleep apnea and gastroesophageal reflux disease (GERD) are common comorbidities of obesity and asthma. The Berlin Questionnaire for Sleep Apnea and the GERD Symptom Assessment Scale will be administered to screen for these conditions and to assess changes in symptoms. In addition, the Pittsburgh Sleep Quality Index will be used to assess participants' usual sleep habits and sleep quality. The 9-item Patient Health Questionnaire (PHQ-9) is both a measure of depressive symptomatology and a tentative diagnostic instrument for the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) depressive disorders.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generic health related Quality of Life</measure>
    <time_frame>6-months post-randomization</time_frame>
    <description>The 12-item Short Form Health Survey (SF-12) is a widely used measure to assess non-disease specific physical and mental health status.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Asthma</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual Care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DASH Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dietary Approaches to Stop Hypertension dietary pattern. Usual care in combination with a DASH intervention consisting of 8 group and 3 individual sessions over 3 months, followed by 3 monthly phone consultations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Dietary Approaches to Stop Hypertension dietary pattern</intervention_name>
    <description>The intervention will employ a series of small group and individual sessions, followed by periodic telephone contacts, to help participants make appropriate dietary changes and develop the skills to maintain these changes over the long term. The initial 3 months of intensive intervention will involve 8 group and 3 individual sessions for 45-60 minutes each. During the next 3 months, participants will receive counseling phone calls once per month for 20-30 minutes each call. Group session sizes may range from 8-15 participants.</description>
    <arm_group_label>DASH Intervention</arm_group_label>
    <other_name>DASH</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ethnicity: All ethnic groups&#xD;
&#xD;
          -  Body mass index (BMI) 18.5-39.9 kg/m2&#xD;
&#xD;
          -  Suboptimally controlled asthma:&#xD;
&#xD;
          -  Diagnosis of asthma on the current medical problem list&#xD;
&#xD;
          -  Currently prescribed at least 1 medication for the treatment of asthma&#xD;
&#xD;
          -  Physiological evidence of asthma with demonstrable reversibility of airway&#xD;
             obstruction, or a specialist's confirmation of asthma diagnosis based on chart review&#xD;
&#xD;
          -  Documented history of high asthma-related emergency and/or inpatient encounters or&#xD;
             reliever medication usage&#xD;
&#xD;
          -  Asthma Control Test: total score &lt;20 or item score &lt;3 for any of the first 4 questions&#xD;
             regarding symptoms (3-6x/week or more), nighttime awakening (1x/week or more),&#xD;
             interference with normal activity (at least some of the time), and rescue medication&#xD;
             use for symptom relief (2-3x/week or more)&#xD;
&#xD;
          -  Kaiser member for ≥1 year&#xD;
&#xD;
          -  PCP approval of study screening&#xD;
&#xD;
          -  Able and willing to enroll and provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intermittent asthma, defined as either seasonal asthma or (daytime asthma symptoms&#xD;
             &lt;2x/week and nocturnal symptoms &lt;2x/month and no use of long-term control medications)&#xD;
&#xD;
          -  Primary diagnosis of COPD (emphysema or chronic bronchitis) on the current medical&#xD;
             problem list or suggested by baseline spirometry and smoking history&#xD;
&#xD;
          -  Previous diabetes (other than during pregnancy) or diabetes diagnosed as a result of&#xD;
             fasting blood glucose or hemoglobin A1c levels obtained at screening&#xD;
&#xD;
          -  Previous cardiovascular disease: e.g., coronary heart disease, cerebrovascular&#xD;
             disease, peripheral vascular disease, heart failure, or aortic aneurysm&#xD;
&#xD;
          -  Diagnosis of cancer (other than non-melanoma skin cancer) that is/was active or&#xD;
             treated with radiation or chemotherapy within the past 2 years&#xD;
&#xD;
          -  Inflammatory bowel disease, colostomy, malabsorption, or major gastrointestinal&#xD;
             resection&#xD;
&#xD;
          -  Diagnosis of bipolar or psychotic disorder or hospitalization for psychological or&#xD;
             emotional problems within the last 2 years&#xD;
&#xD;
          -  Diagnosis of a terminal illness and/or in hospice care&#xD;
&#xD;
          -  Fasting LDL cholesterol &gt;190 mg/dL, triglycerides &gt;500 mg/dl, fasting blood glucose&#xD;
             &gt;125 mg/dl&#xD;
&#xD;
          -  Significant liver enzyme abnormality as indicated by AST or ALT more than 2 times the&#xD;
             upper limit of normal or a clinical diagnosis of hepatitis&#xD;
&#xD;
          -  Renal insufficiency (GFR&lt;60 ml/min)&#xD;
&#xD;
          -  Current use of insulin or oral hypoglycemic agents&#xD;
&#xD;
          -  Use of oral corticosteroids &gt;5 days/month on average&#xD;
&#xD;
          -  Current use of medications for treatment of psychosis or manic-depressive illness&#xD;
&#xD;
          -  Current use of prescription or non-prescription weight-loss products or any&#xD;
             dietary/herbal supplements and unwillingness to discontinue;&#xD;
&#xD;
          -  Inability to speak, read, or understand English at the 6th-grade level or above&#xD;
&#xD;
          -  Inability to perform pulmonary function tests by spirometry in a consistent manner&#xD;
&#xD;
          -  DASH concordance index &gt;60%&#xD;
&#xD;
          -  Unwillingness to modify current diet&#xD;
&#xD;
          -  Current or planned participation in a structured program that overtly focuses on diet&#xD;
             and nutrition&#xD;
&#xD;
          -  Planning to undergo bariatric surgery during the study period&#xD;
&#xD;
          -  Actively attempting to lose weight, or weight change &gt;15 lbs during prior 3 months&#xD;
&#xD;
          -  Consumption of &gt;21 alcoholic drinks per week, or &gt;=6 drinks on one occasion twice or&#xD;
             more per week, or alcoholism as determined by the Alcohol Use Disorders Identification&#xD;
             Test&#xD;
&#xD;
          -  Pregnant, lactating, or planning to become pregnant during the study period&#xD;
&#xD;
          -  No longer a Kaiser patient or planning to transfer care out of Kaiser or to move out&#xD;
             of the area during the study period&#xD;
&#xD;
          -  Family/household member of another study participant or of a study staff member&#xD;
&#xD;
          -  Enrolled or planning to enroll in another research study that would limit full&#xD;
             participation in the study or confound the interpretation of the study's findings&#xD;
&#xD;
          -  Investigator discretion for safety or protocol adherence reasons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Ma, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Palo Alto Medical Foundation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kaiser Permanente, Hayward Medical Center, Allergy Department</name>
      <address>
        <city>Hayward</city>
        <state>California</state>
        <zip>94545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente, San Francisco Medical Center, Allergy Department</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>November 7, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>September 17, 2014</last_update_submitted>
  <last_update_submitted_qc>September 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Palo Alto Medical Foundation</investigator_affiliation>
    <investigator_full_name>Jun Ma, MD, PhD</investigator_full_name>
    <investigator_title>Associate Investigator</investigator_title>
  </responsible_party>
  <keyword>DASH</keyword>
  <keyword>diet</keyword>
  <keyword>asthma</keyword>
  <keyword>adults</keyword>
  <keyword>asthma control</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT01725945
org study id: R34HL108753
secondary id: R34HL108753
nct id: NCT01725945
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot
      study aims to provide effect size estimates and justification, clinical trial and
      intervention feasibility data, and procedural materials for a full-scale randomized
      controlled trial that will determine the efficacy and mechanisms of action of the Dietary
      Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven
      cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled
      asthma.
Dietary intervention efficacy trials are distinctly lacking in asthma research. This pilot
      study aims to provide effect size estimates and justification, clinical trial and
      intervention feasibility data, and procedural materials for a full-scale randomized
      controlled trial that will determine the efficacy and mechanisms of action of the Dietary
      Approaches to Stop Hypertension (DASH)-a recommended dietary pattern based on proven
      cardiovascular benefits-as adjunct therapy to standard care for adults with uncontrolled
      asthma. Eligible, consenting participants (n=90) will be randomized to receive usual care
      alone or combined with a DASH intervention. Follow-up assessments will occur at 3 and 6
      months. By evaluating a dietary pattern approach to improving asthma control, this study
      could advance the evidence base for refining clinical guidelines and public health
      recommendations regarding the role of dietary modifications in asthma management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: 7-item Juniper Asthma Control Questionnaire (ACQ)
time frame: 6-months post-randomizaton
description: The ACQ provides a reliable, validated assessment of asthma control focusing on current impairment. Its 7 items assess the components of current asthma impairment as defined in the asthma treatment guidelines, i.e., daytime and nocturnal asthma symptoms, activity limitations, rescue medication use (excluding use to prevent exercise-induced bronchospasm), and lung function (FEV1). The ACQ is the only guideline-recommended composite measure of asthma control that includes lung function in its overall rating.
measure: Lung function
time frame: 6-months post-randomization
description: Lung function measured by spirometry
measure: Asthma specific Quality of Life
time frame: 6-months post-randomization
description: Juniper Mini Asthma Quality of Life Questionnaire (Mini-AQLQ)
measure: Asthma symptom-free and β2-agonist-free days
time frame: 6-months post-randomization
description: Asthma symptom-free and β2-agonist-free days will be calculated from 2-week asthma symptom diaries.
measure: Asthma-related health care utilization
time frame: 6 months pre-and post-randomization
description: Asthma-related health care utilization will be assessed through data extraction from Kaiser Permanente (KP) electronic databases for the periods of 6 months pre- and post-randomization
measure: Diet adherence
time frame: 6-months post-randomization
description: Participants' adherence to the DASH diet will be assessed by multiple-pass 24-hour diet recalls for servings of fruits, vegetables, dairy products, and whole grains; increases in serum carotenoids, folate and vitamin B12; and reductions in fasting plasma lipids.
measure: Psychosocial predictors of dietary change
time frame: 6-months post-randomization
description: Self-efficacy and social support for dietary change will be assessed using previously validated instruments.
measure: Comorbidities
time frame: 6-months post-randomization
description: Sleep apnea and gastroesophageal reflux disease (GERD) are common comorbidities of obesity and asthma. The Berlin Questionnaire for Sleep Apnea and the GERD Symptom Assessment Scale will be administered to screen for these conditions and to assess changes in symptoms. In addition, the Pittsburgh Sleep Quality Index will be used to assess participants' usual sleep habits and sleep quality. The 9-item Patient Health Questionnaire (PHQ-9) is both a measure of depressive symptomatology and a tentative diagnostic instrument for the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) depressive disorders.
measure: Generic health related Quality of Life
time frame: 6-months post-randomization
description: The 12-item Short Form Health Survey (SF-12) is a widely used measure to assess non-disease specific physical and mental health status.
arm group label: Usual Care
arm group type: No Intervention
description: Usual Care
arm group label: DASH Intervention
arm group type: Experimental
description: Dietary Approaches to Stop Hypertension dietary pattern. Usual care in combination with a DASH intervention consisting of 8 group and 3 individual sessions over 3 months, followed by 3 monthly phone consultations.
intervention type: Behavioral
intervention name: Dietary Approaches to Stop Hypertension dietary pattern
description: The intervention will employ a series of small group and individual sessions, followed by periodic telephone contacts, to help participants make appropriate dietary changes and develop the skills to maintain these changes over the long term. The initial 3 months of intensive intervention will involve 8 group and 3 individual sessions for 45-60 minutes each. During the next 3 months, participants will receive counseling phone calls once per month for 20-30 minutes each call. Group session sizes may range from 8-15 participants.
arm group label: DASH Intervention
other name: DASH
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jun Ma, MD, PhD
role: Principal Investigator
affiliation: Palo Alto Medical Foundation
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Palo Alto Medical Foundation
investigator full name: Jun Ma, MD, PhD
investigator title: Associate Investigator
mesh term: Asthma