<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/NCT03783962</url>
  </required_header>
  <id_info>
    <org_study_id>CHRBSS 19-0131</org_study_id>
    <nct_id>NCT03783962</nct_id>
  </id_info>
  <brief_title>Examining Cooking as a Health Behavior</brief_title>
  <acronym>iChef</acronym>
  <official_title>Examining Cooking as a Health Behavior</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Vermont</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Vermont</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 proposed pilot study will examine cooking as an intervention target for weight control in&#xD;
      overweight adults. The study will also examine whether interventions designed to promote&#xD;
      cooking at home can increase participants' sense of food agency, and overcome common barriers&#xD;
      to cooking at home such as time scarcity and budget constrictions. The study will utilize a&#xD;
      cooking pedagogy designed to not just teach participants the basics of cooking different&#xD;
      foods, but how to be efficient, mindful cooks. If cooking class participation positively&#xD;
      impacts diet and health outcomes, it will bolster the case for promoting cooking at home as a&#xD;
      health behavior for multiple populations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A two arm randomized control trial will examine whether the addition of an active cooking&#xD;
      lesson versus a passive observed lesson to a behavioral weight loss intervention results in&#xD;
      significantly greater weight loss. Additionally, the study will examine whether interventions&#xD;
      designed to promote cooking at home can increase participants' sense of food agency, and&#xD;
      overcome common barriers to cooking at home such as time scarcity and budget constrictions.&#xD;
&#xD;
      Overweight and obese but otherwise healthy participants (n=64) will be recruited. Recruitment&#xD;
      and study initiation will occur in two waves. Wave 1 aims to recruit 32 individuals who will&#xD;
      then be randomized to 1) a 24 week, 24 session group behavioral weight loss intervention with&#xD;
      12 bi-weekly cooking lessons; or, 2) the same 24 week, 24 session group behavioral weight&#xD;
      loss intervention with 12 bi-weekly cooking demonstrations. Both groups get the same&#xD;
      intervention and the same counselor delivered intervention elements; the presence of active&#xD;
      cooking lessons vs. passive observed cooking demonstrations is the only difference between&#xD;
      conditions. Assessments will be conducted at 0, 3 and 6 months. Wave 2 (n=32) will follow the&#xD;
      same process as Wave 1 approximately two months after Wave 1 is initiated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2018</start_date>
  <completion_date type="Actual">September 30, 2019</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</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>
    <intervention_model_description>The Behavioral Weight Loss Program: Investigators have developed and implemented a theory-based group-delivered behavioral weight control program in two previous studies that incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. In addition to attending weekly classes, participants will track their food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on progress.&#xD;
The Cooking Program Active Intervention. Twelve cooking classes will be run every other week after the in-person weight loss meetings.&#xD;
Demonstrations. The demonstration condition will serve as an &quot;attention only&quot; control. All participants will have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Change</measure>
    <time_frame>24 weeks</time_frame>
    <description>Weight loss from baseline at 24 weeks</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change From Baseline in the Total HEI Score, as a Measure of Diet Quality Change</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Difference in diet quality change between groups across assessments. Measured by Healthy Eating Index scores.&#xD;
The HEI includes 13 components that capture recommendations of the 2015-2020 Dietary Guidelines for Americans. There are two groupings of components:&#xD;
Adequacy components are encouraged. Higher scores reflect higher intakes.&#xD;
Moderation components should be limited. Higher scores reflect lower intakes. A higher total HEI score reflects higher diet quality as defined by the Dietary Guidelines for Americans.&#xD;
Components are weighted equally and assigned a score of either 5 or 10. Scores as summed to determine total score. The minimum possible score is 0 and the maximum possible is 100.&#xD;
Adequacy Components:&#xD;
Total Fruits 5 Whole Fruits 5 Total vegetables 5 Greens and beans 5 Whole grains 10 Dairy 10 Total protein foods 5 Seafood and plant proteins 5 Fatty acids 10&#xD;
Moderation Components:&#xD;
Refined grains 10 Sodium 10 Added sugars 10 Saturated fats 10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cooking and Food Practices Change - Total Score</measure>
    <time_frame>24 weeks</time_frame>
    <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Total scores between groups.&#xD;
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-21, higher scores over time indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cooking and Food Practices Change - Structure Subscale</measure>
    <time_frame>24 weeks</time_frame>
    <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Structure subscale scores between groups.&#xD;
Structure subscale measures the ways in which external factors can either hinder or support an individual's cooking and provisioning actions. On a scale of 1-7, higher scores over time indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cooking and Food Practices Change - Attitude Subscale</measure>
    <time_frame>24 weeks</time_frame>
    <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Attitude subscale scores between groups.&#xD;
Structure subscale measures an individual's affective stance towards food, cooking and provisioning in different areas. On a scale of 1-7, higher scores over time indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cooking and Food Practices Change - Self Efficacy Subscale</measure>
    <time_frame>24 weeks</time_frame>
    <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Self Efficacy subscale scores between groups.&#xD;
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-7, higher scores over time indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cooking Frequency Change - Breakfast</measure>
    <time_frame>24 weeks</time_frame>
    <description>Breakfast cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cooking Frequency Change - Lunch</measure>
    <time_frame>24 weeks</time_frame>
    <description>Lunch cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cooking Frequency Change - Dinner</measure>
    <time_frame>24 weeks</time_frame>
    <description>Dinner cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Engagement- Attendance</measure>
    <time_frame>24 weeks</time_frame>
    <description>Percent (of 24 possible) classes attended will be calculated to determine treatment engagement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Engagement- Food Journaling Compliance</measure>
    <time_frame>Baseline to six months</time_frame>
    <description>Percent of weekly food journals at least partially completed (an entry made during a seven day period) will be calculated to determine treatment engagement</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Active Intervention - Cooking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the Nutrition and Food Sciences (NFS) foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Demonstrations - Cooking</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Active Intervention - Cooking</intervention_name>
    <description>Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
    <arm_group_label>Active Intervention - Cooking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Demonstrations - Cooking</intervention_name>
    <description>The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
    <arm_group_label>Demonstrations - Cooking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  only individuals who are cooking (from scratch) no more than 3 meals at home per week&#xD;
             will be eligible.&#xD;
&#xD;
          -  must have a computer or smart device with internet access (at home or work) in order&#xD;
             to track their diet and exercise behaviors,&#xD;
&#xD;
          -  potential participants will be required to demonstrate some ability to comply with&#xD;
             study intervention procedures to be eligible (specifically, they must complete an&#xD;
             online dietary self-monitoring diary for 3 days)&#xD;
&#xD;
          -  must be at least 18 years old and have a BMI between 25-50 kg/m2&#xD;
&#xD;
          -  must agree to be randomized to either study arm and available for both scheduled&#xD;
             meeting times in person on the University of Vermont campus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant or planning to become pregnant in the next 6 months or lactating&#xD;
&#xD;
          -  physical conditions that would preclude exercise&#xD;
&#xD;
          -  medication affecting weight loss&#xD;
&#xD;
          -  currently enrolled in another weight loss program&#xD;
&#xD;
          -  currently cooking more than 3 meals from scratch at home per week&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean R Harvey, PhD, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Vermont</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Vermont</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <results_first_submitted>December 10, 2020</results_first_submitted>
  <results_first_submitted_qc>May 14, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">May 17, 2021</results_first_posted>
  <last_update_submitted>May 14, 2021</last_update_submitted>
  <last_update_submitted_qc>May 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Vermont</investigator_affiliation>
    <investigator_full_name>Jean R. Harvey, PhD, RD</investigator_full_name>
    <investigator_title>Chairperson, Professor, Associate Dean</investigator_title>
  </responsible_party>
  <keyword>behavioral weight loss intervention, obesity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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>June 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03783962/Prot_SAP_001.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>November 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/62/NCT03783962/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active Intervention - Cooking</title>
          <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
        </group>
        <group group_id="P2">
          <title>Demonstrations - Cooking</title>
          <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Intervention - Cooking</title>
          <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the University of Vermont Nutrition and Food Sciences department foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
        </group>
        <group group_id="B2">
          <title>Demonstrations - Cooking</title>
          <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</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="28"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_list>
            </class>
          </class_list>
        </measure>
        <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="55" spread="11"/>
                    <measurement group_id="B2" value="50" spread="11"/>
                    <measurement group_id="B3" value="53" spread="11"/>
                  </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="25"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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_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="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </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/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Non-Hispanic White or Euro-American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Middle Eastern or Arab American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Latino or Hispanic American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to answer</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </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="28"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>High School graduate, GED, Some college</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College Degree</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Graduate Degree, Professional Education</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Separated</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Divorced</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never Married</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Widowed</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Employed</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Retired</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disabled</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>Homemaker</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>Not currently employed</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_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Weight Change</title>
        <description>Weight loss from baseline at 24 weeks</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Weight Change</title>
          <description>Weight loss from baseline at 24 weeks</description>
          <units>kilogram</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.34" spread=".63"/>
                    <measurement group_id="O2" value="4.49" spread=".67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.003</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Total HEI Score, as a Measure of Diet Quality Change</title>
        <description>Difference in diet quality change between groups across assessments. Measured by Healthy Eating Index scores.&#xD;
The HEI includes 13 components that capture recommendations of the 2015-2020 Dietary Guidelines for Americans. There are two groupings of components:&#xD;
Adequacy components are encouraged. Higher scores reflect higher intakes.&#xD;
Moderation components should be limited. Higher scores reflect lower intakes. A higher total HEI score reflects higher diet quality as defined by the Dietary Guidelines for Americans.&#xD;
Components are weighted equally and assigned a score of either 5 or 10. Scores as summed to determine total score. The minimum possible score is 0 and the maximum possible is 100.&#xD;
Adequacy Components:&#xD;
Total Fruits 5 Whole Fruits 5 Total vegetables 5 Greens and beans 5 Whole grains 10 Dairy 10 Total protein foods 5 Seafood and plant proteins 5 Fatty acids 10&#xD;
Moderation Components:&#xD;
Refined grains 10 Sodium 10 Added sugars 10 Saturated fats 10</description>
        <time_frame>Baseline and 24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Total HEI Score, as a Measure of Diet Quality Change</title>
          <description>Difference in diet quality change between groups across assessments. Measured by Healthy Eating Index scores.&#xD;
The HEI includes 13 components that capture recommendations of the 2015-2020 Dietary Guidelines for Americans. There are two groupings of components:&#xD;
Adequacy components are encouraged. Higher scores reflect higher intakes.&#xD;
Moderation components should be limited. Higher scores reflect lower intakes. A higher total HEI score reflects higher diet quality as defined by the Dietary Guidelines for Americans.&#xD;
Components are weighted equally and assigned a score of either 5 or 10. Scores as summed to determine total score. The minimum possible score is 0 and the maximum possible is 100.&#xD;
Adequacy Components:&#xD;
Total Fruits 5 Whole Fruits 5 Total vegetables 5 Greens and beans 5 Whole grains 10 Dairy 10 Total protein foods 5 Seafood and plant proteins 5 Fatty acids 10&#xD;
Moderation Components:&#xD;
Refined grains 10 Sodium 10 Added sugars 10 Saturated fats 10</description>
          <units>points</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.08" spread="2.62"/>
                    <measurement group_id="O2" value="6.23" spread="2.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.97</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooking and Food Practices Change - Total Score</title>
        <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Total scores between groups.&#xD;
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-21, higher scores over time indicate improvement.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooking and Food Practices Change - Total Score</title>
          <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Total scores between groups.&#xD;
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-21, higher scores over time indicate improvement.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Score baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.25" spread=".37"/>
                    <measurement group_id="O2" value="10.41" spread=".37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Score 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.34" spread=".4"/>
                    <measurement group_id="O2" value="13.4" spread=".41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.08</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooking and Food Practices Change - Structure Subscale</title>
        <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Structure subscale scores between groups.&#xD;
Structure subscale measures the ways in which external factors can either hinder or support an individual's cooking and provisioning actions. On a scale of 1-7, higher scores over time indicate improvement.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooking and Food Practices Change - Structure Subscale</title>
          <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Structure subscale scores between groups.&#xD;
Structure subscale measures the ways in which external factors can either hinder or support an individual's cooking and provisioning actions. On a scale of 1-7, higher scores over time indicate improvement.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Structure baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.20" spread=".19"/>
                    <measurement group_id="O2" value="2.74" spread=".19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Structure 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" spread=".20"/>
                    <measurement group_id="O2" value="3.32" spread=".21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.18</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.40</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.01</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooking and Food Practices Change - Attitude Subscale</title>
        <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Attitude subscale scores between groups.&#xD;
Structure subscale measures an individual's affective stance towards food, cooking and provisioning in different areas. On a scale of 1-7, higher scores over time indicate improvement.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooking and Food Practices Change - Attitude Subscale</title>
          <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Attitude subscale scores between groups.&#xD;
Structure subscale measures an individual's affective stance towards food, cooking and provisioning in different areas. On a scale of 1-7, higher scores over time indicate improvement.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Attitude baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.45" spread=".17"/>
                    <measurement group_id="O2" value="4.32" spread=".17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attitude 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.31" spread=".18"/>
                    <measurement group_id="O2" value="5.37" spread=".19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.40</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooking and Food Practices Change - Self Efficacy Subscale</title>
        <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Self Efficacy subscale scores between groups.&#xD;
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-7, higher scores over time indicate improvement.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooking and Food Practices Change - Self Efficacy Subscale</title>
          <description>Difference in baseline and end point Cooking and Food Provisioning Action Scale Self Efficacy subscale scores between groups.&#xD;
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-7, higher scores over time indicate improvement.</description>
          <units>score on a scale</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Self Efficacy baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.59" spread=".15"/>
                    <measurement group_id="O2" value="3.35" spread=".15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self Efficacy 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.65" spread=".17"/>
                    <measurement group_id="O2" value="4.70" spread=".18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.25</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooking Frequency Change - Breakfast</title>
        <description>Breakfast cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooking Frequency Change - Breakfast</title>
          <description>Breakfast cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
          <units>meals cooked</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Breakfast baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" spread=".37"/>
                    <measurement group_id="O2" value="1.54" spread=".37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Breakfast 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.82" spread=".41"/>
                    <measurement group_id="O2" value="1.07" spread=".34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.26</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.41</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.02</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooking Frequency Change - Lunch</title>
        <description>Lunch cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooking Frequency Change - Lunch</title>
          <description>Lunch cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
          <units>meals cooked</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Lunch baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.07" spread=".34"/>
                    <measurement group_id="O2" value="1.07" spread=".34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lunch 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" spread=".38"/>
                    <measurement group_id="O2" value="3.58" spread=".40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.03</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.02</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cooking Frequency Change - Dinner</title>
        <description>Dinner cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Cooking Frequency Change - Dinner</title>
          <description>Dinner cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.</description>
          <units>meals cooked</units>
          <param>Least Squares Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Dinner baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.57" spread=".33"/>
                    <measurement group_id="O2" value="3.25" spread=".33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dinner 24 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.37" spread=".36"/>
                    <measurement group_id="O2" value="4.38" spread=".39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.58</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.05</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.01</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Engagement- Attendance</title>
        <description>Percent (of 24 possible) classes attended will be calculated to determine treatment engagement</description>
        <time_frame>24 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Engagement- Attendance</title>
          <description>Percent (of 24 possible) classes attended will be calculated to determine treatment engagement</description>
          <units>percentage of classes attended</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" lower_limit="77" upper_limit="87"/>
                    <measurement group_id="O2" value="69" lower_limit="29" upper_limit="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.009</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Treatment Engagement- Food Journaling Compliance</title>
        <description>Percent of weekly food journals at least partially completed (an entry made during a seven day period) will be calculated to determine treatment engagement</description>
        <time_frame>Baseline to six months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Intervention - Cooking</title>
            <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
          </group>
          <group group_id="O2">
            <title>Demonstrations - Cooking</title>
            <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</description>
          </group>
        </group_list>
        <measure>
          <title>Treatment Engagement- Food Journaling Compliance</title>
          <description>Percent of weekly food journals at least partially completed (an entry made during a seven day period) will be calculated to determine treatment engagement</description>
          <units>percentage of complete food journals</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="23"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.92" lower_limit="72.00" upper_limit="100"/>
                    <measurement group_id="O2" value="87.75" lower_limit="35.42" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active Intervention - Cooking</title>
          <description>Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the NFS foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.&#xD;
Active Intervention - Cooking: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.&#xD;
Twelve cooking classes will be run every other week after the in-person weight loss meetings.</description>
        </group>
        <group group_id="E2">
          <title>Demonstrations - Cooking</title>
          <description>The demonstration condition will serve as an &quot;attention only&quot; control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to &quot;even out&quot; the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.&#xD;
Demonstrations - Cooking: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.</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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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="28"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>Mattie Alpaugh</name_or_title>
      <organization>University of Vermont Department of Nutrition and Food Sciences</organization>
      <phone>8026569526</phone>
      <email>malpaugh@uvm.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/NCT03783962
org study id: CHRBSS 19-0131
nct id: NCT03783962
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The proposed pilot study will examine cooking as an intervention target for weight control in
      overweight adults. The study will also examine whether interventions designed to promote
      cooking at home can increase participants' sense of food agency, and overcome common barriers
      to cooking at home such as time scarcity and budget constrictions. The study will utilize a
      cooking pedagogy designed to not just teach participants the basics of cooking different
      foods, but how to be efficient, mindful cooks. If cooking class participation positively
      impacts diet and health outcomes, it will bolster the case for promoting cooking at home as a
      health behavior for multiple populations.
A two arm randomized control trial will examine whether the addition of an active cooking
      lesson versus a passive observed lesson to a behavioral weight loss intervention results in
      significantly greater weight loss. Additionally, the study will examine whether interventions
      designed to promote cooking at home can increase participants' sense of food agency, and
      overcome common barriers to cooking at home such as time scarcity and budget constrictions.

      Overweight and obese but otherwise healthy participants (n=64) will be recruited. Recruitment
      and study initiation will occur in two waves. Wave 1 aims to recruit 32 individuals who will
      then be randomized to 1) a 24 week, 24 session group behavioral weight loss intervention with
      12 bi-weekly cooking lessons; or, 2) the same 24 week, 24 session group behavioral weight
      loss intervention with 12 bi-weekly cooking demonstrations. Both groups get the same
      intervention and the same counselor delivered intervention elements; the presence of active
      cooking lessons vs. passive observed cooking demonstrations is the only difference between
      conditions. Assessments will be conducted at 0, 3 and 6 months. Wave 2 (n=32) will follow the
      same process as Wave 1 approximately two months after Wave 1 is initiated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The Behavioral Weight Loss Program: Investigators have developed and implemented a theory-based group-delivered behavioral weight control program in two previous studies that incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. In addition to attending weekly classes, participants will track their food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on progress.
The Cooking Program Active Intervention. Twelve cooking classes will be run every other week after the in-person weight loss meetings.
Demonstrations. The demonstration condition will serve as an "attention only" control. All participants will have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.
primary purpose: Treatment
masking: None (Open Label)
measure: Weight Change
time frame: 24 weeks
description: Weight loss from baseline at 24 weeks
measure: Change From Baseline in the Total HEI Score, as a Measure of Diet Quality Change
time frame: Baseline and 24 weeks
description: Difference in diet quality change between groups across assessments. Measured by Healthy Eating Index scores.
The HEI includes 13 components that capture recommendations of the 2015-2020 Dietary Guidelines for Americans. There are two groupings of components:
Adequacy components are encouraged. Higher scores reflect higher intakes.
Moderation components should be limited. Higher scores reflect lower intakes. A higher total HEI score reflects higher diet quality as defined by the Dietary Guidelines for Americans.
Components are weighted equally and assigned a score of either 5 or 10. Scores as summed to determine total score. The minimum possible score is 0 and the maximum possible is 100.
Adequacy Components:
Total Fruits 5 Whole Fruits 5 Total vegetables 5 Greens and beans 5 Whole grains 10 Dairy 10 Total protein foods 5 Seafood and plant proteins 5 Fatty acids 10
Moderation Components:
Refined grains 10 Sodium 10 Added sugars 10 Saturated fats 10
measure: Cooking and Food Practices Change - Total Score
time frame: 24 weeks
description: Difference in baseline and end point Cooking and Food Provisioning Action Scale Total scores between groups.
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-21, higher scores over time indicate improvement.
measure: Cooking and Food Practices Change - Structure Subscale
time frame: 24 weeks
description: Difference in baseline and end point Cooking and Food Provisioning Action Scale Structure subscale scores between groups.
Structure subscale measures the ways in which external factors can either hinder or support an individual's cooking and provisioning actions. On a scale of 1-7, higher scores over time indicate improvement.
measure: Cooking and Food Practices Change - Attitude Subscale
time frame: 24 weeks
description: Difference in baseline and end point Cooking and Food Provisioning Action Scale Attitude subscale scores between groups.
Structure subscale measures an individual's affective stance towards food, cooking and provisioning in different areas. On a scale of 1-7, higher scores over time indicate improvement.
measure: Cooking and Food Practices Change - Self Efficacy Subscale
time frame: 24 weeks
description: Difference in baseline and end point Cooking and Food Provisioning Action Scale Self Efficacy subscale scores between groups.
Structure subscale measures whether an individual thinks their cooking ability and skills are adequate. On a scale of 1-7, higher scores over time indicate improvement.
measure: Cooking Frequency Change - Breakfast
time frame: 24 weeks
description: Breakfast cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.
measure: Cooking Frequency Change - Lunch
time frame: 24 weeks
description: Lunch cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.
measure: Cooking Frequency Change - Dinner
time frame: 24 weeks
description: Dinner cooking frequency was assessed at baseline and 24 weeks using the cooking frequency subscale from the Cooking Perceptions/Attitudes/Confidence/Behaviors Survey. The scores range from a minimum of 0 to a maximum of 7 meals cooked during a one week period.
measure: Treatment Engagement- Attendance
time frame: 24 weeks
description: Percent (of 24 possible) classes attended will be calculated to determine treatment engagement
measure: Treatment Engagement- Food Journaling Compliance
time frame: Baseline to six months
description: Percent of weekly food journals at least partially completed (an entry made during a seven day period) will be calculated to determine treatment engagement
arm group label: Active Intervention - Cooking
arm group type: Experimental
description: Twelve cooking classes will be run every other week after the in-person weight loss meetings. These lessons will be patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for individuals specifically interested in weight loss. Classes will begin with a brief lecture on the day's topic, followed by a laboratory session. Participants work in teams of two in the Nutrition and Food Sciences (NFS) foods lab to actively practice skills and cook a meal. Subjects will receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. Classes will be taught by a chef trained in the pedagogy by Dr. Trubek and participants will have the opportunity to sample the food they prepared at the end of class.
arm group label: Demonstrations - Cooking
arm group type: Active Comparator
description: The demonstration condition will serve as an "attention only" control. Previous research suggests that demonstrations of cooking have little to no impact on cooking behavior, therefore, cooking demonstrations can be used to "even out" the time and attention devoted to the active cooking participants without introducing bias into the study design. Subjects in the demonstration condition will also begin with a brief lecture on the day's lesson followed by a cooking demonstration that covers the same topics as the active intervention group. All participants will receive the same printed information and also have an opportunity to sample the prepared food at the end of class. The demonstrations will be led by the same chef as the active intervention group.
intervention type: Behavioral
intervention name: Active Intervention - Cooking
description: Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.
Twelve cooking classes will be run every other week after the in-person weight loss meetings.
arm group label: Active Intervention - Cooking
intervention type: Behavioral
intervention name: Demonstrations - Cooking
description: The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.
arm group label: Demonstrations - Cooking
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jean R Harvey, PhD, RD
role: Principal Investigator
affiliation: University of Vermont
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Vermont
investigator full name: Jean R. Harvey, PhD, RD
investigator title: Chairperson, Professor, Associate Dean
mesh term: Obesity
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 