<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/NCT01734655</url>
  </required_header>
  <id_info>
    <org_study_id>PBRC 12013</org_study_id>
    <secondary_id>U01DK094418</secondary_id>
    <nct_id>NCT01734655</nct_id>
  </id_info>
  <brief_title>Study of the Validity of Using the MEQ to Measure Mindful Eating in Pregnant Women</brief_title>
  <acronym>MEQ</acronym>
  <official_title>Qualitative Evaluation of the Mindful Eating Questionnaire (MEQ) in Pregnant Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pennington Biomedical Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Pennington Biomedical Research Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Specific Aim of this supplemental project is to evaluate the Mindful Eating Questionnaire&#xD;
      (MEQ) to determine if it is a valid instrument for pregnant women. During this project, the&#xD;
      MEQ will be qualitatively evaluated in a sample of pregnant women who are similar in age,&#xD;
      ethnicity, education, and marital status to the women targeted for recruitment in the parent&#xD;
      study. The qualitative evaluation will include a focus group with 10 participants followed by&#xD;
      30 individual cognitive interviews. Comments from the interviews will be summarized and&#xD;
      analyzed systematically for each of the 28 questions of the MEQ and the interviewer will use&#xD;
      findings from initial interviews to inform subsequent interviews. Content validity will be&#xD;
      evaluated based on responses from the focus group and cognitive interviews, and MEQ items&#xD;
      will be evaluated for comprehension, retrieval, judgment, and response. Strengths,&#xD;
      weaknesses, relevance, comprehensiveness, and interpretations will be reported for each of&#xD;
      the MEQ questions. We will also have some of the more traditional validation parameters (the&#xD;
      inclusion of other questionnaires) in the study to collect data on convergent and&#xD;
      discriminant validity. The resulting publication will provide readers with a thorough report&#xD;
      on the utility and appropriateness of using the MEQ to quantify mindful eating in pregnant&#xD;
      women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pre-pregnancy maternal overweight/obesity and excess weight gain during pregnancy are&#xD;
      associated with metabolic abnormalities in mothers and their offspring. Despite guidelines&#xD;
      developed by the Institute of Medicine (IOM) for appropriate levels of gestational weight&#xD;
      gain, more than 50% of overweight and obese pregnant women exceed the recommended amount of&#xD;
      weight gain during pregnancy (CDC 2009). Updated guidelines from the Institute of Medicine&#xD;
      (IOM) in 2009 suggest that individualized dietary counseling and regular physical activity&#xD;
      are necessary for pregnant women to achieve appropriate levels of gestational weight gain&#xD;
      (IOM and NRC 2009), yet few studies have examined weight management in overweight pregnant&#xD;
      women and none were successful at increasing adherence to the IOM guidelines (Polley, Wing et&#xD;
      al. 2002; Olson, Strawderman et al. 2004; Asbee, Jenkins et al. 2009; Shirazian, Monteith et&#xD;
      al. 2010; Phelan, Phipps et al. 2011).&#xD;
&#xD;
      This project is a supplement to a parent study called Expecting Success: Personalized&#xD;
      management of body weight during pregnancy (U01 DK094418-01 PIs: Leanne M. Redman, Ph.D. &amp;&#xD;
      Corby K. Martin, Ph.D.). The parent study will test the efficacy of two interventions at&#xD;
      promoting appropriate levels of weight gain during pregnancy compared to each other and to a&#xD;
      usual care control group. Appropriate levels of weight gain during pregnancy will be defined&#xD;
      by the 2009 IOM gestational weight gain guidelines (CDC 2009). The two interventions include&#xD;
      training on mindfulness surrounding eating, hunger, and satiety; hence, it is logical to test&#xD;
      if changes in mindfulness differ between the two intervention groups and the usual care&#xD;
      group. Moreover, it is possible that change in mindfulness will be associated with the&#xD;
      study's outcome or different levels of gestational weight gain between the usual care group&#xD;
      and the two intervention groups. Finally, changes in mindfulness could mediate the effect of&#xD;
      the two interventions on gestational weight gain.&#xD;
&#xD;
      Despite the possible importance of mindfulness to the eating behavior and weight management&#xD;
      of pregnant women, no measure has been validated to measure mindfulness in pregnant women.&#xD;
      The Mindful Eating Questionnaire (MEQ) is a 28-item self-report instrument that measures five&#xD;
      domains of mindful eating: disinhibition, awareness, external cues, emotional response, and&#xD;
      distraction. Mindful eating refers to an unbiased awareness of sensations surrounding eating&#xD;
      and although a preliminary study found the MEQ to be a valid measure of mindful eating in&#xD;
      healthy adults, it has not been validated in pregnant women. A valid measure of mindful&#xD;
      eating is required when an intervention is used to increase mindful eating in pregnant women&#xD;
      and evaluate if the increase results in healthier eating habits and effective weight&#xD;
      management. Indeed, effectively measuring mindful eating is central to evaluating: 1) if an&#xD;
      intervention had the anticipated effect on mindful eating, 2) if increasing mindful eating&#xD;
      resulted in changes to eating habits and body mass, and 3) if changes in mindful eating&#xD;
      mediated treatment effects.&#xD;
&#xD;
      Relationship of the supplement to the parent grant: Mindfulness training is effective at&#xD;
      helping people manage their eating habits, making mindfulness training a viable strategy to&#xD;
      use with special populations who struggle with eating and weight management, including&#xD;
      pregnant women. During the parent study, two personal weight-management interventions&#xD;
      designed to meet the unique needs of pregnant women will be deployed and mindful eating&#xD;
      techniques are part of these interventions. Although a preliminary study found the Mindful&#xD;
      Eating Questionnaire (MEQ) to be valid in a convenience sample of generally healthy adults,&#xD;
      it is not known if the MEQ is an appropriate and valid instrument for use with pregnant&#xD;
      women, and the proposed project will answer this question. If the MEQ is valid for use with&#xD;
      pregnant women, it can be used in the parent study, as well as other studies, to determine if&#xD;
      the interventions are effectively at training participant to mindfully eat and if changes in&#xD;
      mindful eating mediate intervention effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)</measure>
    <time_frame>SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits</time_frame>
    <description>Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a</measure>
    <time_frame>V1</time_frame>
    <description>Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a &quot;high&quot; value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale</measure>
    <time_frame>V1</time_frame>
    <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale</measure>
    <time_frame>V1</time_frame>
    <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale</measure>
    <time_frame>V1</time_frame>
    <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation of the MEQ Subscales to the MAAS</measure>
    <time_frame>V1</time_frame>
    <description>The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Pregnancy</condition>
  <arm_group>
    <arm_group_label>All Participants</arm_group_label>
    <description>Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Forty pregnant women (11 will participate in the focus group and 29 will complete&#xD;
        individual cognitive interviews) will be recruited who are similar in age, ethnicity,&#xD;
        education, and marital status to the women who will be recruited for the parent study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-40 years of age, inclusive&#xD;
&#xD;
          -  Overweight or obese at time of conception based on self-report (BMI ≥25 and &lt;40 kg/m2)&#xD;
&#xD;
          -  Willingness to participate in either the focus group or the individual interview&#xD;
&#xD;
          -  Establish prenatal care by 12 weeks of gestation&#xD;
&#xD;
          -  Fluent in the English language; AND&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current multiple gestation&#xD;
&#xD;
          -  Type I diabetes&#xD;
&#xD;
          -  Self-reported gestational diabetes mellitus&#xD;
&#xD;
          -  History or current psychotic disorder&#xD;
&#xD;
          -  Current major depressive episode, bipolar disorder, or eating disorder&#xD;
&#xD;
          -  HIV&#xD;
&#xD;
          -  Current smoking, alcohol or drug use&#xD;
&#xD;
          -  History of ≥ 3 miscarriages&#xD;
&#xD;
          -  Current enrollment in Expecting Success (IRB#11024)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pennington Biomedical Research Center</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70808</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.pbrc.edu/clinical-trials/?studyid=156</url>
    <description>PBRC Web Screener for MEQ</description>
  </link>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <results_first_submitted>July 20, 2015</results_first_submitted>
  <results_first_submitted_qc>February 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 3, 2016</results_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pennington Biomedical Research Center</investigator_affiliation>
    <investigator_full_name>Corby K. Martin</investigator_full_name>
    <investigator_title>Associate Professor, Director Ingestive Behavior Laboratory</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Participants</title>
          <description>Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices in either a focus group format (the first 11 participants) or cognitive interview format (the last 29 participants).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants were pregnant women between the ages of 18-40 with a self-reported pre-pregnancy BMI between 25 and 40. All women had a singleton pregnancy and were otherwise healthy.</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-pregnancy BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.0" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Pre-pregnancy Body Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83.5" spread="17.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gestational Age</title>
          <units>weeks</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19.9" spread="8.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.8" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Body Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86.5" spread="14.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)</title>
        <description>Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.</description>
        <time_frame>SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits</time_frame>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.</description>
          </group>
        </group_list>
        <measure>
          <title>Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)</title>
          <description>Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.</description>
          <units>test-retest coefficent</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a</title>
        <description>Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a &quot;high&quot; value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency).</description>
        <time_frame>V1</time_frame>
        <population>Pregnant women who were overweight or obese and 18-40 yrs of age.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>All Participants</description>
          </group>
        </group_list>
        <measure>
          <title>To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a</title>
          <description>Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a &quot;high&quot; value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency).</description>
          <population>Pregnant women who were overweight or obese and 18-40 yrs of age.</population>
          <units>Ratio of Variance</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Disinhibition</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awareness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>External Cues</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Response</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distraction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale</title>
        <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.</description>
        <time_frame>V1</time_frame>
        <population>Pregnant women who were overweight or obese and 18-40 yrs of age.</population>
        <group_list>
          <group group_id="O1">
            <title>All Participants</title>
            <description>all participants</description>
          </group>
        </group_list>
        <measure>
          <title>Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale</title>
          <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.</description>
          <population>Pregnant women who were overweight or obese and 18-40 yrs of age.</population>
          <units>correlation coefficients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Disinhibition**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awareness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>External Cues</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Response**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distraction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w ECS)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w/o ECS)**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.01</p_value>
            <method>correlation analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale</title>
        <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.</description>
        <time_frame>V1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants</title>
            <description>Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.</description>
          </group>
        </group_list>
        <measure>
          <title>Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale</title>
          <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.</description>
          <units>correlation coefficients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Disinhibition**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awareness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>External Cues</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Response**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distraction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w ECS)**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w/o ECS)**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.01</p_value>
            <method>correlation analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale</title>
        <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.</description>
        <time_frame>V1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants</title>
            <description>Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.</description>
          </group>
        </group_list>
        <measure>
          <title>Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale</title>
          <description>The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.</description>
          <units>correlation coefficients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Disinhibition**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awareness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>External Cues</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Response**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distraction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w ECS)**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w/o ECS)**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;.01</p_value>
            <method>correlation analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Correlation of the MEQ Subscales to the MAAS</title>
        <description>The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level</description>
        <time_frame>V1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Participants</title>
            <description>Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.</description>
          </group>
        </group_list>
        <measure>
          <title>Correlation of the MEQ Subscales to the MAAS</title>
          <description>The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level</description>
          <units>correlation coefficients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Disinhibition**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Awareness</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".245"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>External Cues</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Emotional Response**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distraction**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w ECS)**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score (w/o ECS)**</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>All Participants</title>
          <description>Pregnant women who were overweight or obese and 18-40 yrs of age.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Pain</sub_title>
                <description>A participant reported that she had experienced some abdominal pain. This was determined to be non-serious and unrelated to the study by the medical investigator.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Vaginal Spotting</sub_title>
                <description>A participant reported that she had experienced some vaginal spotting. She visited her OB/GYN and it was determined to be harmless. This was determined to be non-serious and unrelated to the study by the medical investigator.</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Corby K. Martin</name_or_title>
      <organization>Pennington Biomedical Research Center</organization>
      <phone>225-763-2585</phone>
      <email>corby.martin@pbrc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01734655
org study id: PBRC 12013
secondary id: U01DK094418
nct id: NCT01734655
lead sponsor: 
collaborator: 
has dmc: Yes
The Specific Aim of this supplemental project is to evaluate the Mindful Eating Questionnaire
      (MEQ) to determine if it is a valid instrument for pregnant women. During this project, the
      MEQ will be qualitatively evaluated in a sample of pregnant women who are similar in age,
      ethnicity, education, and marital status to the women targeted for recruitment in the parent
      study. The qualitative evaluation will include a focus group with 10 participants followed by
      30 individual cognitive interviews. Comments from the interviews will be summarized and
      analyzed systematically for each of the 28 questions of the MEQ and the interviewer will use
      findings from initial interviews to inform subsequent interviews. Content validity will be
      evaluated based on responses from the focus group and cognitive interviews, and MEQ items
      will be evaluated for comprehension, retrieval, judgment, and response. Strengths,
      weaknesses, relevance, comprehensiveness, and interpretations will be reported for each of
      the MEQ questions. We will also have some of the more traditional validation parameters (the
      inclusion of other questionnaires) in the study to collect data on convergent and
      discriminant validity. The resulting publication will provide readers with a thorough report
      on the utility and appropriateness of using the MEQ to quantify mindful eating in pregnant
      women.
Pre-pregnancy maternal overweight/obesity and excess weight gain during pregnancy are
      associated with metabolic abnormalities in mothers and their offspring. Despite guidelines
      developed by the Institute of Medicine (IOM) for appropriate levels of gestational weight
      gain, more than 50% of overweight and obese pregnant women exceed the recommended amount of
      weight gain during pregnancy (CDC 2009). Updated guidelines from the Institute of Medicine
      (IOM) in 2009 suggest that individualized dietary counseling and regular physical activity
      are necessary for pregnant women to achieve appropriate levels of gestational weight gain
      (IOM and NRC 2009), yet few studies have examined weight management in overweight pregnant
      women and none were successful at increasing adherence to the IOM guidelines (Polley, Wing et
      al. 2002; Olson, Strawderman et al. 2004; Asbee, Jenkins et al. 2009; Shirazian, Monteith et
      al. 2010; Phelan, Phipps et al. 2011).

      This project is a supplement to a parent study called Expecting Success: Personalized
      management of body weight during pregnancy (U01 DK094418-01 PIs: Leanne M. Redman, Ph.D. &
      Corby K. Martin, Ph.D.). The parent study will test the efficacy of two interventions at
      promoting appropriate levels of weight gain during pregnancy compared to each other and to a
      usual care control group. Appropriate levels of weight gain during pregnancy will be defined
      by the 2009 IOM gestational weight gain guidelines (CDC 2009). The two interventions include
      training on mindfulness surrounding eating, hunger, and satiety; hence, it is logical to test
      if changes in mindfulness differ between the two intervention groups and the usual care
      group. Moreover, it is possible that change in mindfulness will be associated with the
      study's outcome or different levels of gestational weight gain between the usual care group
      and the two intervention groups. Finally, changes in mindfulness could mediate the effect of
      the two interventions on gestational weight gain.

      Despite the possible importance of mindfulness to the eating behavior and weight management
      of pregnant women, no measure has been validated to measure mindfulness in pregnant women.
      The Mindful Eating Questionnaire (MEQ) is a 28-item self-report instrument that measures five
      domains of mindful eating: disinhibition, awareness, external cues, emotional response, and
      distraction. Mindful eating refers to an unbiased awareness of sensations surrounding eating
      and although a preliminary study found the MEQ to be a valid measure of mindful eating in
      healthy adults, it has not been validated in pregnant women. A valid measure of mindful
      eating is required when an intervention is used to increase mindful eating in pregnant women
      and evaluate if the increase results in healthier eating habits and effective weight
      management. Indeed, effectively measuring mindful eating is central to evaluating: 1) if an
      intervention had the anticipated effect on mindful eating, 2) if increasing mindful eating
      resulted in changes to eating habits and body mass, and 3) if changes in mindful eating
      mediated treatment effects.

      Relationship of the supplement to the parent grant: Mindfulness training is effective at
      helping people manage their eating habits, making mindfulness training a viable strategy to
      use with special populations who struggle with eating and weight management, including
      pregnant women. During the parent study, two personal weight-management interventions
      designed to meet the unique needs of pregnant women will be deployed and mindful eating
      techniques are part of these interventions. Although a preliminary study found the Mindful
      Eating Questionnaire (MEQ) to be valid in a convenience sample of generally healthy adults,
      it is not known if the MEQ is an appropriate and valid instrument for use with pregnant
      women, and the proposed project will answer this question. If the MEQ is valid for use with
      pregnant women, it can be used in the parent study, as well as other studies, to determine if
      the interventions are effectively at training participant to mindfully eat and if changes in
      mindful eating mediate intervention effects.
observational model: Cohort
time perspective: Cross-Sectional
measure: Test-Retest Reliability of the Mindful Eating Questionnaire (MEQ)
time frame: SV and V1; minimum of 24 hours between visits, maximum of 5 months between visits
description: Participants were given the Mindful Eating Questionnaire (MEQ) at their screening visit and study visit in an effort to establish test-retest reliability.
measure: To Determine the Internal Validity of Each of the MEQ's Subscales, we Calculated Cronbach's a
time frame: V1
description: Cronbach's alpha is a measure of internal consistency, that is, how closely related a set of items are as a group. It is considered to be a measure of scale reliability. Alpha coefficients generally range from 0 to 1, with a higher score indicating greater reliability of a scale. However, a "high" value for alpha does not imply that the measure is unidimensional. Technically speaking, Cronbach's alpha is not a statistical test - it is a coefficient of reliability (or consistency).
measure: Convergent Validity of the Mindful Eating Questionnaire Compared to the Eating Inventory (EI) Restraint Subscale
time frame: V1
description: The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory (EI) subscales (restraint, disinhibition, hunger) by calculating Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory restraint subscale. Correlations were run with and without the External Cues subscale (ECS) since it was found not to be internally consistent.
measure: Convergent Validity of the Mindful Eating Questionnaire Subscales to the Eating Inventory Disinhibition Subscale
time frame: V1
description: The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Disinhibition. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.
measure: Convergent Validity of the MEQ Subscales Compared to the EI Hunger Subscale
time frame: V1
description: The convergent validity of the Mindful Eating Questionnaire was assessed using the Eating Inventory subscales of restraint, disinhibition and hunger by calculating the Pearson correlation coefficients. Below are the results for the comparison of the Mindful Eating Questionnaire's subscales to the Eating Inventory Subscale of Hunger. Correlations were run with and without the External Cues subscale since it was found not to be internally consistent.
measure: Correlation of the MEQ Subscales to the MAAS
time frame: V1
description: The convergent validity of the MEQ was also assessed by calculating the pearson correlation between the MEQ subscales and the Mindful Attention Awareness Scale (MAAS). Correlations were run with and without the External Cues subscale since it was found not to be internally consistent. **Indicates correlation significant at the .01 level
arm group label: All Participants
description: Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://www.pbrc.edu/clinical-trials/?studyid=156
description: PBRC Web Screener for MEQ
responsible party type: Principal Investigator
investigator affiliation: Pennington Biomedical Research Center
investigator full name: Corby K. Martin
investigator title: Associate Professor, Director Ingestive Behavior Laboratory
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 