<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/NCT02208180</url>
  </required_header>
  <id_info>
    <org_study_id>14-1500</org_study_id>
    <secondary_id>1P50HL105184-01</secondary_id>
    <nct_id>NCT02208180</nct_id>
  </id_info>
  <brief_title>Heart Healthy Lenoir: Return of Results Study</brief_title>
  <acronym>HHL</acronym>
  <official_title>Heart Healthy Lenoir: Return of Results Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are conducting a two group intervention to study to the effect of&#xD;
      individualized heart disease genomic risk results on motivation towards diet and physical&#xD;
      activity behaviors to reduce heart disease risk. The intervention includes provided&#xD;
      participants with genomic and lifestyle risk estimates. Investigators will follow&#xD;
      participants for 3 months to determine if motivation towards and engagement in diet and&#xD;
      physical activity behaviors change.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2016</completion_date>
  <primary_completion_date type="Actual">May 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in motivation</measure>
    <time_frame>Baseline, Post-interview, 3 months</time_frame>
    <description>The Prevention and Planning Behaviors Scale is a recently developed tool that provides a direct measure of degrees of influence on participants' motivation to change their health behavior in translational genomic studies. It has 23-items where participants rate themselves using a 5-point Likert scale (1=A Lot Less Motivated to 5=A Lot More Motivated).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Eating Habits</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Eating habits will be assessed using a 10-item Block questionnaire designed to capture the frequency with which participants eat particular items from different food groups. Participants will rate themselves on a 6-point scale ranging from &quot;Less than 1 time per WEEK&quot; to &quot;2+ a DAY.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Physical Activity</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>The 16-item RESIDE Neighborhood Physical Activity Questionnaire will be used to assess context-specific walking behavior through self-report. Participants are asked how often they walk, how long, to where, and similar questions about what other types of physical activity they might engage in. Giles-Corti B, Timperio A, Cutt H, Pikora TJ, Bull FC, Knuiman M, et al. Development of a reliable measure of walking within and outside the local neighborhood: RESIDE's Neighborhood Physical Activity Questionnaire. Preventive medicine 2006;42(6):455-459.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Psychological Adaptation</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>The Psychological Adaptation Scale (PAS) measures adaptation to health risk information via a 20-item questionnaire rated on a 5-point Likert scale (1=Not At All to 5=Very Much). This questionnaire measures adaptation in 4 domains: coping efficacy, self-esteem, social integration, and spiritual well-being. This scale was developed specifically for use in genomic studies to measure adaptation and aid understanding in the relationship between health outcomes and psychological well-being. Biesecker BB, Erby LH, Woolford S, Adcock JY, Cohen JS, Lamb A, et al. Development and validation of the Psychological Adaptation Scale (PAS): Use in six studies of adaptation to a health condition or risk. Patient Educ Couns 2013.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Cardiovascular Disease</condition>
  <arm_group>
    <arm_group_label>Return of genomic results on cardiovascular disease risk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive genomic cardiovascular disease risk information.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Return of lifestyle results on cardiovascular disease risk</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Return of genomic results on cardiovascular disease risk</intervention_name>
    <description>Experimental group: Participants will receive genomic cardiovascular disease risk information.&#xD;
Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.</description>
    <arm_group_label>Return of genomic results on cardiovascular disease risk</arm_group_label>
    <arm_group_label>Return of lifestyle results on cardiovascular disease risk</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled in Heart Healthy Lenoir Genomics&#xD;
&#xD;
          -  African-American (self-identified)&#xD;
&#xD;
          -  Wants to be contacted for future studies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrolled in an arm of the Heart Healthy Lenoir Lifestyle study with intense behavioral&#xD;
             intervention (e.g. weight loss or weight maintenance programs)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harlyn G Skinner, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alice Ammerman, DrPH, MPH</last_name>
    <role>Study Chair</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Heart Healthy Lenoir Field Office</name>
      <address>
        <city>Kinston</city>
        <state>North Carolina</state>
        <zip>28501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>June 4, 2016</last_update_submitted>
  <last_update_submitted_qc>June 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 7, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Chapel Hill</investigator_affiliation>
    <investigator_full_name>Harlyn Skinner, MS</investigator_full_name>
    <investigator_title>Doctoral Candidate</investigator_title>
  </responsible_party>
  <keyword>Return of results</keyword>
  <keyword>Genomics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</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/NCT02208180
org study id: 14-1500
secondary id: 1P50HL105184-01
nct id: NCT02208180
lead sponsor: 
collaborator: 
has dmc: Yes
The investigators are conducting a two group intervention to study to the effect of
      individualized heart disease genomic risk results on motivation towards diet and physical
      activity behaviors to reduce heart disease risk. The intervention includes provided
      participants with genomic and lifestyle risk estimates. Investigators will follow
      participants for 3 months to determine if motivation towards and engagement in diet and
      physical activity behaviors change.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in motivation
time frame: Baseline, Post-interview, 3 months
description: The Prevention and Planning Behaviors Scale is a recently developed tool that provides a direct measure of degrees of influence on participants' motivation to change their health behavior in translational genomic studies. It has 23-items where participants rate themselves using a 5-point Likert scale (1=A Lot Less Motivated to 5=A Lot More Motivated).
measure: Change in Eating Habits
time frame: Baseline, 3 months
description: Eating habits will be assessed using a 10-item Block questionnaire designed to capture the frequency with which participants eat particular items from different food groups. Participants will rate themselves on a 6-point scale ranging from "Less than 1 time per WEEK" to "2+ a DAY."
measure: Change in Physical Activity
time frame: Baseline, 3 months
description: The 16-item RESIDE Neighborhood Physical Activity Questionnaire will be used to assess context-specific walking behavior through self-report. Participants are asked how often they walk, how long, to where, and similar questions about what other types of physical activity they might engage in. Giles-Corti B, Timperio A, Cutt H, Pikora TJ, Bull FC, Knuiman M, et al. Development of a reliable measure of walking within and outside the local neighborhood: RESIDE's Neighborhood Physical Activity Questionnaire. Preventive medicine 2006;42(6):455-459.
measure: Change in Psychological Adaptation
time frame: Baseline, 3 months
description: The Psychological Adaptation Scale (PAS) measures adaptation to health risk information via a 20-item questionnaire rated on a 5-point Likert scale (1=Not At All to 5=Very Much). This questionnaire measures adaptation in 4 domains: coping efficacy, self-esteem, social integration, and spiritual well-being. This scale was developed specifically for use in genomic studies to measure adaptation and aid understanding in the relationship between health outcomes and psychological well-being. Biesecker BB, Erby LH, Woolford S, Adcock JY, Cohen JS, Lamb A, et al. Development and validation of the Psychological Adaptation Scale (PAS): Use in six studies of adaptation to a health condition or risk. Patient Educ Couns 2013.
arm group label: Return of genomic results on cardiovascular disease risk
arm group type: Experimental
description: Participants will receive genomic cardiovascular disease risk information.
arm group label: Return of lifestyle results on cardiovascular disease risk
arm group type: Active Comparator
description: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.
intervention type: Behavioral
intervention name: Return of genomic results on cardiovascular disease risk
description: Experimental group: Participants will receive genomic cardiovascular disease risk information.
Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study.
arm group label: Return of genomic results on cardiovascular disease risk
arm group label: Return of lifestyle results on cardiovascular disease risk
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Harlyn G Skinner, MS
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Alice Ammerman, DrPH, MPH
role: Study Chair
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Chapel Hill
investigator full name: Harlyn Skinner, MS
investigator title: Doctoral Candidate
mesh term: Cardiovascular Diseases