<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/NCT03799289</url>
  </required_header>
  <id_info>
    <org_study_id>2096-18</org_study_id>
    <secondary_id>R03DK115978-01A1</secondary_id>
    <nct_id>NCT03799289</nct_id>
  </id_info>
  <brief_title>Approaches for Improving Long-term Weight Loss</brief_title>
  <official_title>Examination of the Feasibility and Preliminary Efficacy of Two Approaches for Improving Long-term Weight Loss</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Miriam Hospital</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>The Miriam Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine two approaches for improving long-term weight loss&#xD;
      success. All participants will receive a 12-week, in-person standard behavioral weight loss&#xD;
      program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary&#xD;
      education instruction (determined via randomization procedures). Assessments of weight,&#xD;
      physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and&#xD;
      6 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Behavioral weight loss (WL) programs result in clinically significant weight losses; however&#xD;
      rates of long-term WL maintenance are poor. Previous studies suggest that long-term WL&#xD;
      success may require an enhanced ability to overcome physiological and hedonic urges to eat&#xD;
      and an improved capacity for dealing with life stressors, negative mood states, and food&#xD;
      cravings. Thus interventions which target stress reduction and reduce the tendency to use&#xD;
      food as a coping strategy for aversive experiences may offer a protective effect against&#xD;
      dietary lapses; thereby improving long-term WL outcomes. Yoga is a mind-body intervention&#xD;
      which reduces stress and improves overall physical and psychological well-being and offers&#xD;
      promise for strengthening the psychological skill set needed for maintaining important&#xD;
      weight-related behaviors long-term. The physical and cognitive skills practiced within yoga&#xD;
      target multiple underlying psychological processes (e.g., mindfulness, distress tolerance)&#xD;
      which could reduce emotional eating, improve dietary choices, and enhance one's ability to&#xD;
      tolerate food cravings or hedonic urges to eat. While yoga is an effective treatment approach&#xD;
      for other chronic health conditions, it has not been examined as a potential intervention for&#xD;
      improving long-term WL outcomes. Within the context of the obesity field, yoga has been&#xD;
      viewed as a mode of exercise and not necessarily as a mind-body intervention approach (as is&#xD;
      the case in other fields). Thus, given the lower caloric expenditure of yoga in comparison to&#xD;
      many forms of aerobic exercise, the effect of yoga on important weight- related processes and&#xD;
      behaviors has not been examined.&#xD;
&#xD;
      The primary aims of this study are to examine the feasibility and acceptability of&#xD;
      implementing yoga within a weight management program. Secondary aims focus on examining the&#xD;
      impact of yoga, relative to a cooking/dietary education intervention (matched for contact&#xD;
      time) on important psychological constructs (perceived stress, mindfulness, and distress&#xD;
      tolerance) and weight. Sixty women with overweight or obesity will be randomly assigned to a&#xD;
      12-week standard behavioral WL program, followed by either 12 weeks of group-based yoga or 12&#xD;
      weeks of cooking/dietary information classes. Both groups will be instructed to self-monitor&#xD;
      and achieve the dietary and aerobic exercise goals throughout the 24-week program. Primary&#xD;
      assessments will occur at baseline and weeks 12 and 24.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">December 29, 2020</completion_date>
  <primary_completion_date type="Actual">June 18, 2020</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>Program Satisfaction Ratings</measure>
    <time_frame>6 months</time_frame>
    <description>Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Session Attendance</measure>
    <time_frame>6 months</time_frame>
    <description>Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of the Intervention (Retention)</measure>
    <time_frame>6 months</time_frame>
    <description>Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Perceived Stress (Measured Via the Perceived Stress Scale)</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Weight</measure>
    <time_frame>Change from 12 to 24 weeks</time_frame>
    <description>Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Iyengar Yoga</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cooking/dietary education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral weight loss followed by yoga instruction</intervention_name>
    <description>12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
    <arm_group_label>Iyengar Yoga</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Behavioral weight loss followed by cooking/dietary education instruction</intervention_name>
    <description>12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
    <arm_group_label>Cooking/dietary education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI 25-40 kg/m2&#xD;
&#xD;
          -  Female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of any condition that would limit one's ability to exercise or lose weight&#xD;
             safely&#xD;
&#xD;
          -  Recent weight loss&#xD;
&#xD;
          -  Current or recent enrollment in a weight loss or mindfulness-based treatment program&#xD;
&#xD;
          -  Women who are pregnant or planning on becoming pregnant&#xD;
&#xD;
          -  History of a serious psychiatric disorder&#xD;
&#xD;
          -  Recent cancer diagnosis (&lt;1 year)&#xD;
&#xD;
          -  Does not own a smartphone&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jessica Unick, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Miriam Hospital's Weight Control &amp; Diabetes Research Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Weight Control and Diabetes Research Center</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>September 1, 2021</results_first_submitted>
  <results_first_submitted_qc>October 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2021</results_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Weight loss</keyword>
  <keyword>physical activity</keyword>
  <keyword>yoga</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/Prot_SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03799289/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Iyengar Yoga</title>
          <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
        </group>
        <group group_id="P2">
          <title>Cooking/Dietary Education</title>
          <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Initial Weight Loss Program (Weeks 1-12)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Maintenance Intervention (Weeks 13-24)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>60 participants enrolled in this trial. A total of 51 completed the 12-week weight loss program and thus found out their randomization assignment to either the yoga or cooking/dietary education condition. Information presented is on those 51 participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Iyengar Yoga</title>
          <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
        </group>
        <group group_id="B2">
          <title>Cooking/Dietary Education</title>
          <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="24"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="51"/>
          </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="48.7" spread="9.9"/>
                    <measurement group_id="B2" value="49.1" spread="9.5"/>
                    <measurement group_id="B3" value="48.7" spread="9.6"/>
                  </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="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="45"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" 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="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI) at baseline (pre weight loss)</title>
          <units>kg /m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.6" spread="4.1"/>
                    <measurement group_id="B2" value="34.5" spread="3.5"/>
                    <measurement group_id="B3" value="34.6" spread="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body mass index (BMI) at 12 weeks (post weight loss intervention)</title>
          <description>Post-12 week weight loss was considered the 'new baseline' for those receiving the the yoga and cooking interventions, as we were examining these as intervention approaches for improving long-term weight loss</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.1" spread="4.5"/>
                    <measurement group_id="B2" value="31.8" spread="3.7"/>
                    <measurement group_id="B3" value="32.4" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Program Satisfaction Ratings</title>
        <description>Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Program Satisfaction Ratings</title>
          <description>Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="2.9"/>
                    <measurement group_id="O2" value="8.3" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Intervention Session Attendance</title>
        <description>Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Intervention Session Attendance</title>
          <description>Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).</description>
          <units>percentage of sessions attended</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.4" spread="24.6"/>
                    <measurement group_id="O2" value="75.9" spread="27.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of the Intervention (Retention)</title>
        <description>Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of the Intervention (Retention)</title>
          <description>Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Perceived Stress (Measured Via the Perceived Stress Scale)</title>
        <description>Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Perceived Stress (Measured Via the Perceived Stress Scale)</title>
          <description>Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.01" spread="0.51"/>
                    <measurement group_id="O2" value="-0.06" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale</title>
        <description>The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale</title>
          <description>The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="5.9"/>
                    <measurement group_id="O2" value="0.9" spread="3.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale</title>
        <description>The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale</title>
          <description>The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
          <units>Change on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.17" spread="5.1"/>
                    <measurement group_id="O2" value="-0.9" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale</title>
        <description>This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale</title>
          <description>This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.29" spread="3.06"/>
                    <measurement group_id="O2" value="0.04" spread="5.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale</title>
        <description>This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale</title>
          <description>This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
          <units>Change on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.46" spread="4.34"/>
                    <measurement group_id="O2" value="0.74" spread="4.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale</title>
        <description>This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale</title>
          <description>This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.33" spread="3.17"/>
                    <measurement group_id="O2" value="-1.67" spread="3.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)</title>
        <description>The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)</title>
          <description>The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.51"/>
                    <measurement group_id="O2" value="-0.06" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Weight</title>
        <description>Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.</description>
        <time_frame>Change from 12 to 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Iyengar Yoga</title>
            <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
          </group>
          <group group_id="O2">
            <title>Cooking/Dietary Education</title>
            <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Weight</title>
          <description>Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.</description>
          <units>Percent weight change</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.33" spread="2.91"/>
                    <measurement group_id="O2" value="-0.38" spread="4.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Iyengar Yoga</title>
          <description>Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.&#xD;
Behavioral weight loss followed by yoga instruction: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention</description>
        </group>
        <group group_id="E2">
          <title>Cooking/Dietary Education</title>
          <description>Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.&#xD;
Behavioral weight loss followed by cooking/dietary education instruction: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </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>Jessica Unick, PD (Principal Investigator)</name_or_title>
      <organization>The Miriam Hospital</organization>
      <phone>401-793-8966</phone>
      <email>junick@lifespan.org</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/NCT03799289
org study id: 2096-18
secondary id: R03DK115978-01A1
nct id: NCT03799289
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to examine two approaches for improving long-term weight loss
      success. All participants will receive a 12-week, in-person standard behavioral weight loss
      program followed by either 12 weeks of yoga instruction or 12 weeks of cooking/dietary
      education instruction (determined via randomization procedures). Assessments of weight,
      physical activity, dietary behaviors, and psychosocial factors will occur at baseline, 3, and
      6 months.
Behavioral weight loss (WL) programs result in clinically significant weight losses; however
      rates of long-term WL maintenance are poor. Previous studies suggest that long-term WL
      success may require an enhanced ability to overcome physiological and hedonic urges to eat
      and an improved capacity for dealing with life stressors, negative mood states, and food
      cravings. Thus interventions which target stress reduction and reduce the tendency to use
      food as a coping strategy for aversive experiences may offer a protective effect against
      dietary lapses; thereby improving long-term WL outcomes. Yoga is a mind-body intervention
      which reduces stress and improves overall physical and psychological well-being and offers
      promise for strengthening the psychological skill set needed for maintaining important
      weight-related behaviors long-term. The physical and cognitive skills practiced within yoga
      target multiple underlying psychological processes (e.g., mindfulness, distress tolerance)
      which could reduce emotional eating, improve dietary choices, and enhance one's ability to
      tolerate food cravings or hedonic urges to eat. While yoga is an effective treatment approach
      for other chronic health conditions, it has not been examined as a potential intervention for
      improving long-term WL outcomes. Within the context of the obesity field, yoga has been
      viewed as a mode of exercise and not necessarily as a mind-body intervention approach (as is
      the case in other fields). Thus, given the lower caloric expenditure of yoga in comparison to
      many forms of aerobic exercise, the effect of yoga on important weight- related processes and
      behaviors has not been examined.

      The primary aims of this study are to examine the feasibility and acceptability of
      implementing yoga within a weight management program. Secondary aims focus on examining the
      impact of yoga, relative to a cooking/dietary education intervention (matched for contact
      time) on important psychological constructs (perceived stress, mindfulness, and distress
      tolerance) and weight. Sixty women with overweight or obesity will be randomly assigned to a
      12-week standard behavioral WL program, followed by either 12 weeks of group-based yoga or 12
      weeks of cooking/dietary information classes. Both groups will be instructed to self-monitor
      and achieve the dietary and aerobic exercise goals throughout the 24-week program. Primary
      assessments will occur at baseline and weeks 12 and 24.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Program Satisfaction Ratings
time frame: 6 months
description: Participants were asked, 'How satisfied were you with the yoga or cooking/dietary education intervention that you received over the past 3 months' on a 1-10 scale (1=very dissatisfied, 10=very satisfied)
measure: Intervention Session Attendance
time frame: 6 months
description: Yoga or control intervention sessions attended, expressed as a percentage (# of sessions completed/# of sessions possible x 100).
measure: Feasibility of the Intervention (Retention)
time frame: 6 months
description: Number of participants completing the 6-month assessment visit. Percentage of total participants can be computed as follows: the number of participants completing the 6-month assessment divided by the total number of participants who completed the 3-month weight loss program and learned of their randomization assignment
measure: Changes in Perceived Stress (Measured Via the Perceived Stress Scale)
time frame: Change from 12 to 24 weeks
description: Perceived stress scores range from 0-40, with higher scores indicating higher perceived stress. Change in perceived stress was calculated as follows: 24-week perceived stress score minus 12-week perceived stress score. Negative change scores indicate that perceived stress was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that perceived stress increased.
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Observing Subscale
time frame: Change from 12 to 24 weeks
description: The observation subscale assesses the ways we use our sensory awareness. It involves how we see, feel, and perceive the internal and external world around us and select the stimuli that require our attention and focus. Mindfulness subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Describing Subscale
time frame: Change from 12 to 24 weeks
description: The describing subscale evaluates the way we label our experiences and express them in words to ourselves and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Acting With Awareness Subscale
time frame: Change from 12 to 24 weeks
description: This subscale examines whether we can act out of quick judgment and get out of the autopilot mode before responding to a situation. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-judgmental Inner Critic Subscale
time frame: Change from 12 to 24 weeks
description: This subscale assesses the degree of self-acceptance and unconditional empathy for oneself and others. Subscale scores range from 8-40, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
measure: Change in Dispositional Mindfulness (Assessed Via the Five Facet Mindfulness Questionnaire) - Non-reactivity Subscale
time frame: Change from 12 to 24 weeks
description: This subscale assesses active detachment from negative thoughts and emotions so that we can accept their existence and choose not to react to them. Subscale scores range from 7-35, with higher scores indicating greater mindfulness. Change in mindfulness subscale was calculated as follows: 24-week mindfulness subscale score minus 12-week mindfulness subscale score. Negative change scores indicate that mindfulness was reduced as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that mindfulness increased.
measure: Change in Distress Tolerance (Assessed Via the Distress Tolerance Scale)
time frame: Change from 12 to 24 weeks
description: The Distress Tolerance Scale is a 15-item measure designed to assess one's perceived ability to tolerate emotional distress. Total scores range from 15-75 with higher scores on the scale indicate greater levels of distress tolerance. Change in distress tolerance was calculated as follows: 24-week distress tolerance score minus 12-week distress tolerance score. Negative change scores indicate that distress tolerance decreased as a result of the yoga or cooking/dietary education intervention whereas positive scores indicate that distress tolerance increased.
measure: Change in Weight
time frame: Change from 12 to 24 weeks
description: Calculated as the percentage of weight lost from 12 to 24 weeks, as a result of the yoga or cooking/dietary education interventions. It was calculated as follows: (24-week weight minus 12-week weight) / 12-week weight x 100. Positive numbers indicate weight gain whereas negative numbers indicate weight loss.
arm group label: Iyengar Yoga
arm group type: Experimental
description: Participants randomized to the yoga intervention arm will receive 12 weeks of group-based yoga instruction, following a 12-week standard behavioral weight loss program. Group-based yoga instruction will occur twice per week and classes will be 60 minutes in duration. The yoga program will consist of breathing, postural, and meditation practices and home-based yoga practice will also be prescribed.
arm group label: Cooking/dietary education
arm group type: Active Comparator
description: Participants randomized to the cooking/dietary education intervention arm will receive 12 weeks of group-based, cooking/dietary education instruction, following a 12-week standard behavioral weight loss program. This group-based instruction will occur twice per week and classes will be 60 minutes in duration. Classes will focus on providing basic nutrition knowledge and culinary skills, and will include cooking demonstrations.
intervention type: Behavioral
intervention name: Behavioral weight loss followed by yoga instruction
description: 12-week standard behavioral weight loss program followed by a 12-week yoga intervention
arm group label: Iyengar Yoga
intervention type: Behavioral
intervention name: Behavioral weight loss followed by cooking/dietary education instruction
description: 12-week standard behavioral weight loss program followed by a 12-week cooking/dietary education intervention
arm group label: Cooking/dietary education
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jessica Unick, PhD
role: Principal Investigator
affiliation: The Miriam Hospital's Weight Control & Diabetes Research Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 