<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/NCT01695837</url>
  </required_header>
  <id_info>
    <org_study_id>5P20RR016464-11/8</org_study_id>
    <secondary_id>5P20RR016464</secondary_id>
    <nct_id>NCT01695837</nct_id>
  </id_info>
  <brief_title>Live Well: A Practical and Effective Low-Intensity Dietary Counseling Intervention for Use in Primary Care Patients With Dyslipidemia</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nevada, Las Vegas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity&#xD;
      dietary counseling intervention provided by the primary care physician (PCP), in patients at&#xD;
      risk for cardiovascular diseases&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this study is to design and evaluate the feasibility and the effect on diet&#xD;
      quality and blood lipids a new dietary counseling intervention that will be sustainable in&#xD;
      the &quot;real-world&quot; settings of the current clinical practice. The intervention will be&#xD;
      initiated by the primary care physician during the routine office visits and will use paper&#xD;
      and web-based counseling materials. Internet based healthcare, or e-healthcare, is a consumer&#xD;
      focused health care delivery paradigm that physicians and the healthcare system can no longer&#xD;
      ignore. Lifestyle counseling and preventive medicine are potentially ideal areas of patient&#xD;
      care that could be provided efficiently through this emerging venue of healthcare delivery.&#xD;
      Internet access is near-universal for Americans under the age of 60: 90% of 18-29 year-olds,&#xD;
      85% of 30-49 year-olds, and 70% of 50-64 year-olds.&#xD;
&#xD;
      The aims of this study are: 1) - develop a patient self-administered, computerized version of&#xD;
      the paper-based Rate-your-Plate dietary screening Questionnaire; 2) - create counseling&#xD;
      materials on diet and cholesterol and build a secure, HIPAA compliant, interactive web-based&#xD;
      counseling application that will allow patients to receive personalized counseling base on&#xD;
      the results of the screening dietary questionnaire and the goals chosen by the patients; 3) -&#xD;
      to test the feasibility of this intervention in the clinical settings of primary care, and&#xD;
      evaluate its effect on lipids panel at 3 and 6 months .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDL-Cholesterol</measure>
    <time_frame>up to 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Cholesterol</measure>
    <time_frame>at 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>at 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL-Cholesterol</measure>
    <time_frame>at 3 and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diet score</measure>
    <time_frame>at 3 and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">61</enrollment>
  <condition>Dyslipidemia</condition>
  <arm_group>
    <arm_group_label>Group A-dietary counseling month 0-6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group A Visit #1 - Weight, height, blood pressure and pulse were measured at the beginning of the visit. During a &quot;focused office visit&quot; the primary care physician (PCP) reviewed the results of the fasting lipid panel and diet test with the patient; the PCP provide the patient with written educational materials and access to the counseling website. Weekly automatic emails sent to patient reminding to visit the counseling website&#xD;
Visit #2 - Same as visit #1. Weekly automatic emails sent to patient reminding to visit the counseling website.&#xD;
Visit #3 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a &quot;focused office visit&quot; the PCP reviewed the results of the new fasting lipid panel and diet test with the patient.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B- Dietary counseling month 3-6</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group B Visit #1: Weight, height, blood pressure and pulse were measured at the beginning of the visit. Follow up visit and lab order were scheduled for 3 months. No blood test or diet test results were reviewed with the patient.&#xD;
Visit #2 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a &quot;focused office visit&quot; the PCP reviewed the results of the two fasting lipid panels ; the PCP provide the patient with written educational materials and access to the counseling website. Weekly automatic emails sent to patient reminding to visit the counseling website&#xD;
Visit #3 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a &quot;focused office visit&quot; the PCP reviewed the results of the new fasting lipid panel and diet test with the patient.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6</intervention_name>
    <arm_group_label>Group A-dietary counseling month 0-6</arm_group_label>
    <arm_group_label>Group B- Dietary counseling month 3-6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligibility required documentation of a LDL-cholesterol level of 130 mg/dL or higher&#xD;
             within the 12 months prior to enrollment. Potential subjects were also required to&#xD;
             have access to the Internet and an active email account. The use of lipid lowering&#xD;
             drugs was not an exclusion, but patients taking these drugs had be on the same&#xD;
             medication and dose for at least 3 months prior to enrollment, with no changes&#xD;
             anticipated for the duration of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded patients with poorly controlled diabetes mellitus (defined by HbA1c&gt;9%),&#xD;
             serum creatinine above 1.5 mg/dL, malignancy, cirrhosis, eating disorders, acute&#xD;
             coronary syndrome in the last three months, congestive heart failure NYHA class lll&#xD;
             and lV, ongoing warfarin therapy, uncontrolled hypo- or hyperthyroidism, ongoing&#xD;
             weight loss, history of bariatric surgery, pregnant women, and patients who scored&#xD;
             more than 250 (on a scale of 100 to 300) on a food frequency questionnaire&#xD;
             administered on the day of enrollment. Patients with a history of triglycerides &gt;400&#xD;
             mg/dl were also excluded, since we used the Friedewald formula [LDL-C=Total&#xD;
             cholesterol-(TGs/5+HDL-C)] to calculate LDL-cholesterol levels.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Doina Kulick, MD, MS</last_name>
    <role>Study Director</role>
    <affiliation>University of Nevada School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNSOM Internal Medicine</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 28, 2012</study_first_posted>
  <last_update_submitted>September 27, 2012</last_update_submitted>
  <last_update_submitted_qc>September 27, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 28, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>Doina Kulick, MD</investigator_full_name>
    <investigator_title>Associate Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Diet counseling</keyword>
  <keyword>primary care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</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/NCT01695837
org study id: 5P20RR016464-11/8
secondary id: 5P20RR016464
nct id: NCT01695837
lead sponsor: 
has dmc: No
The purpose of this study was to evaluate the effects on lipids and diet of a low-intensity
      dietary counseling intervention provided by the primary care physician (PCP), in patients at
      risk for cardiovascular diseases
The objective of this study is to design and evaluate the feasibility and the effect on diet
      quality and blood lipids a new dietary counseling intervention that will be sustainable in
      the "real-world" settings of the current clinical practice. The intervention will be
      initiated by the primary care physician during the routine office visits and will use paper
      and web-based counseling materials. Internet based healthcare, or e-healthcare, is a consumer
      focused health care delivery paradigm that physicians and the healthcare system can no longer
      ignore. Lifestyle counseling and preventive medicine are potentially ideal areas of patient
      care that could be provided efficiently through this emerging venue of healthcare delivery.
      Internet access is near-universal for Americans under the age of 60: 90% of 18-29 year-olds,
      85% of 30-49 year-olds, and 70% of 50-64 year-olds.

      The aims of this study are: 1) - develop a patient self-administered, computerized version of
      the paper-based Rate-your-Plate dietary screening Questionnaire; 2) - create counseling
      materials on diet and cholesterol and build a secure, HIPAA compliant, interactive web-based
      counseling application that will allow patients to receive personalized counseling base on
      the results of the screening dietary questionnaire and the goals chosen by the patients; 3) -
      to test the feasibility of this intervention in the clinical settings of primary care, and
      evaluate its effect on lipids panel at 3 and 6 months .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: LDL-Cholesterol
time frame: up to 6 months
measure: Total Cholesterol
time frame: at 3 and 6 months
measure: Triglycerides
time frame: at 3 and 6 months
measure: HDL-Cholesterol
time frame: at 3 and 6 months
measure: diet score
time frame: at 3 and 6 months
arm group label: Group A-dietary counseling month 0-6
arm group type: Experimental
description: Group A Visit #1 - Weight, height, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the primary care physician (PCP) reviewed the results of the fasting lipid panel and diet test with the patient; the PCP provide the patient with written educational materials and access to the counseling website. Weekly automatic emails sent to patient reminding to visit the counseling website
Visit #2 - Same as visit #1. Weekly automatic emails sent to patient reminding to visit the counseling website.
Visit #3 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the PCP reviewed the results of the new fasting lipid panel and diet test with the patient.
arm group label: Group B- Dietary counseling month 3-6
arm group type: Other
description: Group B Visit #1: Weight, height, blood pressure and pulse were measured at the beginning of the visit. Follow up visit and lab order were scheduled for 3 months. No blood test or diet test results were reviewed with the patient.
Visit #2 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the PCP reviewed the results of the two fasting lipid panels ; the PCP provide the patient with written educational materials and access to the counseling website. Weekly automatic emails sent to patient reminding to visit the counseling website
Visit #3 - Weight, blood pressure and pulse were measured at the beginning of the visit. During a "focused office visit" the PCP reviewed the results of the new fasting lipid panel and diet test with the patient.
intervention type: Behavioral
intervention name: Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6
arm group label: Group A-dietary counseling month 0-6
arm group label: Group B- Dietary counseling month 3-6
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Doina Kulick, MD, MS
role: Study Director
affiliation: University of Nevada School of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: Doina Kulick, MD
investigator title: Associate Professor of Medicine
mesh term: Dyslipidemias