<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/NCT03257657</url>
  </required_header>
  <id_info>
    <org_study_id>16-1932</org_study_id>
    <secondary_id>UL1TR002535</secondary_id>
    <nct_id>NCT03257657</nct_id>
  </id_info>
  <brief_title>Helping Moms to be Healthy After Baby</brief_title>
  <official_title>Helping Moms to be Healthy After Baby</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Colorado Clinical &amp; Translational Sciences Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Center for Advancing Translational Sciences (NCATS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      Low-income and minority women are at increased risk for postpartum weight retention (i.e.&#xD;
      retaining weight after pregnancy) and consequent persistent obesity. Women who are obese&#xD;
      pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the&#xD;
      postpartum period than non-obese women. Aims for this pilot study are listed below:&#xD;
&#xD;
      Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss&#xD;
      intervention delivered in a WIC setting to a population of low-income, predominantly&#xD;
      racial/ethnic minority, obese, postpartum women.&#xD;
&#xD;
      Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy,&#xD;
      readiness to change, motivations to eat between intervention and control participants to&#xD;
      determine preliminary intervention efficacy over a 12-week period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low-income and minority women are at increased risk for postpartum weight retention (i.e.&#xD;
      retaining weight after pregnancy) and consequent persistent obesity. Women who are obese&#xD;
      pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the&#xD;
      postpartum period than non-obese women.&#xD;
&#xD;
      Obesity science supports that weight loss interventions should be multi-component with&#xD;
      regular points of contact. Building upon this, we have designed a multi-component&#xD;
      intervention that considers the demands on women in the postpartum period and utilizes&#xD;
      technology for both provider decision support and for virtual contact with participants. The&#xD;
      intervention will address diet, physical activity, and social support through the use of&#xD;
      in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and&#xD;
      Facebook.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">February 22, 2018</completion_date>
  <primary_completion_date type="Actual">February 22, 2018</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>This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of Recruitment</measure>
    <time_frame>Once the final participant is recruited</time_frame>
    <description>The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition Rate of Subjects Enrolled in the Study</measure>
    <time_frame>Once the final participant completes the 12 week visit</time_frame>
    <description>The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visit Attendance</measure>
    <time_frame>Baseline through Week 12, reported at Week 12</time_frame>
    <description>The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of a Weight Loss Intervention</measure>
    <time_frame>12 weeks</time_frame>
    <description>To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluation of the Use of Phone Coaching</measure>
    <time_frame>12 weeks</time_frame>
    <description>Investigators will count the total number of times any participant used phone coaching.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Weight Between Visits</measure>
    <time_frame>Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks</time_frame>
    <description>To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Diet: Intakes Measured in Grams</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Physical Activity</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Diet and Physical Activity Self-efficacy</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.&#xD;
Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.&#xD;
Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.&#xD;
Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Motivations to Eat</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.&#xD;
Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Readiness to Change</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Diet: Intakes Measured in Cups</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Diet: kCal Intake</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Weight Loss</condition>
  <condition>Diet Modification</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Observational Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lifestyle Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Observation Group participants</intervention_name>
    <description>Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
    <arm_group_label>Observational Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Lifestyle group participants</intervention_name>
    <description>Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
    <arm_group_label>Lifestyle Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult woman (≥18 and &lt;50 years old).&#xD;
&#xD;
          -  Enrolled in WIC or with an infant enrolled in WIC.&#xD;
&#xD;
          -  3-12 months postpartum.&#xD;
&#xD;
          -  A pre-pregnancy BMI of 25 - 40 kg/m2 (based on self-reported height and weight prior&#xD;
             to pregnancy).&#xD;
&#xD;
          -  Postpartum body mass index between 25 and 50 kg/m2.&#xD;
&#xD;
          -  English- and/or Spanish-speaking.&#xD;
&#xD;
          -  Owns a mobile phone with texting functionality in order to receive texts during the&#xD;
             trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Health conditions impacting weight or ability to participate in a weight loss trial.&#xD;
&#xD;
          -  Pregnancy or planned pregnancy in next 5 months.&#xD;
&#xD;
          -  Any health problems or undergoing any treatments that might interfere with what&#xD;
             participant eats or her ability to exercise.&#xD;
&#xD;
          -  Medical provider recommendation to avoid exercise.&#xD;
&#xD;
          -  Plans to be in a different geographic area within the next 5 months.&#xD;
&#xD;
          -  Plans to stop coming to Aurora WIC in the next 5 months.&#xD;
&#xD;
          -  Unable to give informed consent.&#xD;
&#xD;
          -  Not able to read and understand English or Spanish at an 8th grade level.&#xD;
&#xD;
          -  Not willing to create a Facebook account if they do not already have one.&#xD;
&#xD;
          -  Asked to follow-up in &lt; 3 months at most recent WIC visit.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darcy A Thompson, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aurora WIC Office</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80011</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <results_first_submitted>May 31, 2019</results_first_submitted>
  <results_first_submitted_qc>March 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 20, 2020</results_first_posted>
  <last_update_submitted>March 6, 2020</last_update_submitted>
  <last_update_submitted_qc>March 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 8, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/57/NCT03257657/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Observational Group</title>
          <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
        </group>
        <group group_id="P2">
          <title>Lifestyle Group</title>
          <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
              </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="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawn</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noted not eligible right after enrolled</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>Observational Group</title>
          <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
        </group>
        <group group_id="B2">
          <title>Lifestyle Group</title>
          <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</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="22"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="41"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31.2" spread="6.6"/>
                    <measurement group_id="B2" value="30.5" spread="5.0"/>
                    <measurement group_id="B3" value="30.9" spread="5.8"/>
                  </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="22"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>African American, non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White, non-Hispanic</title>
              <category_list>
                <category>
                  <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>Feasibility of Recruitment</title>
        <description>The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment</description>
        <time_frame>Once the final participant is recruited</time_frame>
        <population>One participant was consented but determined before receiving any interventions that they did not meet all eligibility criteria. This participant is excluded from the lifestyle group.</population>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of Recruitment</title>
          <description>The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment</description>
          <population>One participant was consented but determined before receiving any interventions that they did not meet all eligibility criteria. This participant is excluded from the lifestyle group.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Attrition Rate of Subjects Enrolled in the Study</title>
        <description>The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.</description>
        <time_frame>Once the final participant completes the 12 week visit</time_frame>
        <population>The 1 participant originally enrolled, but removed right after enrollment because was determined not eligible is not included in the Lifestyle group count.</population>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Attrition Rate of Subjects Enrolled in the Study</title>
          <description>The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.</description>
          <population>The 1 participant originally enrolled, but removed right after enrollment because was determined not eligible is not included in the Lifestyle group count.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Visit Attendance</title>
        <description>The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported</description>
        <time_frame>Baseline through Week 12, reported at Week 12</time_frame>
        <population>2 participants are excluded from analysis: Participant who was withdrawn was not included in analysis. Participant identified as not eligible right after enrollment is not included either.</population>
        <group_list>
          <group group_id="O1">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Visit Attendance</title>
          <description>The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported</description>
          <population>2 participants are excluded from analysis: Participant who was withdrawn was not included in analysis. Participant identified as not eligible right after enrollment is not included either.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Attended all 4 visits (Baseline, 4 week visit, 8</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Attended 3 of 4 visits (Baseline, 4 or 8 week visi</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Attended 2 of 4 visits (baseline and 12 week visi</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Attended 0 intervention visits</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of a Weight Loss Intervention</title>
        <description>To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.</description>
        <time_frame>12 weeks</time_frame>
        <population>Data was not available for analysis for one participant. This participant was not analyzed. The three participants lost to follow-up before the baseline visit were not available for interview and are excluded.</population>
        <group_list>
          <group group_id="O1">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of a Weight Loss Intervention</title>
          <description>To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.</description>
          <population>Data was not available for analysis for one participant. This participant was not analyzed. The three participants lost to follow-up before the baseline visit were not available for interview and are excluded.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Evaluation of the Use of Phone Coaching</title>
        <description>Investigators will count the total number of times any participant used phone coaching.</description>
        <time_frame>12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Evaluation of the Use of Phone Coaching</title>
          <description>Investigators will count the total number of times any participant used phone coaching.</description>
          <units>Number of phone coaching sessions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Weight Between Visits</title>
        <description>To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.</description>
        <time_frame>Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Weight Between Visits</title>
          <description>To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.</description>
          <units>pounds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.8" spread="6.4"/>
                    <measurement group_id="O2" value="-4.7" spread="7.5"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.1</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Diet: Intakes Measured in Grams</title>
        <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Data missing for one Lifestyle Group participant at the 12 week point</population>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Diet: Intakes Measured in Grams</title>
          <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.</description>
          <population>Data missing for one Lifestyle Group participant at the 12 week point</population>
          <units>Grams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Saturated fat (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="8.1"/>
                    <measurement group_id="O2" value="-4.1" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Trans fat (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="3.5"/>
                    <measurement group_id="O2" value="-1.2" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total sugars (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-35.1" spread="50.4"/>
                    <measurement group_id="O2" value="-25.2" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Added sugars (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.7" spread="39.5"/>
                    <measurement group_id="O2" value="-23.3" spread="33.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>protein (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-10.2" spread="22.2"/>
                    <measurement group_id="O2" value="-6.3" spread="25.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>total fat (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.9" spread="24.5"/>
                    <measurement group_id="O2" value="-9.4" spread="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>carbohydrates (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-40.9" spread="79.8"/>
                    <measurement group_id="O2" value="-46.7" spread="48.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>fiber (g)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.1" spread="4.8"/>
                    <measurement group_id="O2" value="-0.4" spread="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Physical Activity</title>
        <description>To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Physical Activity</title>
          <description>To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.</description>
          <units>MET-h/week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-45.5" spread="176"/>
                    <measurement group_id="O2" value="38.6" spread="126"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.13</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Diet and Physical Activity Self-efficacy</title>
        <description>To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.&#xD;
Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.&#xD;
Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.&#xD;
Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Diet and Physical Activity Self-efficacy</title>
          <description>To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.&#xD;
Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.&#xD;
Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.&#xD;
Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Physical activity: Sticking to it</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.5" spread="0.9"/>
                    <measurement group_id="O2" value="0.4" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical activity: making time for exercise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="1.0"/>
                    <measurement group_id="O2" value="0.0" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diet</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="3.1"/>
                    <measurement group_id="O2" value="-0.1" spread="7.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Motivations to Eat</title>
        <description>To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.&#xD;
Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Motivations to Eat</title>
          <description>To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.&#xD;
Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.3" spread="9.6"/>
                    <measurement group_id="O2" value="5.9" spread="12.0"/>
                  </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>Other</non_inferiority_type>
            <p_value>0.02</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Readiness to Change</title>
        <description>Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Readiness to Change</title>
          <description>Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Losing weight</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Healthy eating</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0" upper_limit="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical activity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="-1" upper_limit="1"/>
                    <measurement group_id="O2" value="1.0" lower_limit="0" upper_limit="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Diet: Intakes Measured in Cups</title>
        <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Data missing for one Lifestyle Group participant at the 12 week point</population>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Diet: Intakes Measured in Cups</title>
          <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.</description>
          <population>Data missing for one Lifestyle Group participant at the 12 week point</population>
          <units>Cups</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fruit and fruit juice (cups)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="1.5"/>
                    <measurement group_id="O2" value="0" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>vegetable intake (cups)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.1" spread="0.9"/>
                    <measurement group_id="O2" value="0.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Diet: kCal Intake</title>
        <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <population>Data missing for one Lifestyle Group participant at the 12 week point</population>
        <group_list>
          <group group_id="O1">
            <title>Observational Group</title>
            <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
          </group>
          <group group_id="O2">
            <title>Lifestyle Group</title>
            <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Diet: kCal Intake</title>
          <description>To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.</description>
          <population>Data missing for one Lifestyle Group participant at the 12 week point</population>
          <units>kcal</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-294" spread="531.7"/>
                    <measurement group_id="O2" value="-297" spread="374.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Observational Group</title>
          <description>Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.&#xD;
Observation Group participants: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.</description>
        </group>
        <group group_id="E2">
          <title>Lifestyle Group</title>
          <description>Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.&#xD;
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.&#xD;
Lifestyle group participants: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.</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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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>Darcy Thompson, Associate Professor</name_or_title>
      <organization>University of Colorado</organization>
      <phone>303 724 7471</phone>
      <email>darcy.thompson@ucdenver.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/NCT03257657
org study id: 16-1932
secondary id: UL1TR002535
nct id: NCT03257657
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Low-income and minority women are at increased risk for postpartum weight retention (i.e.
      retaining weight after pregnancy) and consequent persistent obesity. Women who are obese
      pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the
      postpartum period than non-obese women. Aims for this pilot study are listed below:

      Aim 1: To evaluate the feasibility and acceptability of a multi-component novel weight loss
      intervention delivered in a WIC setting to a population of low-income, predominantly
      racial/ethnic minority, obese, postpartum women.

      Aim 2: To evaluate differences in weight change, diet, physical activity, self-efficacy,
      readiness to change, motivations to eat between intervention and control participants to
      determine preliminary intervention efficacy over a 12-week period.
Low-income and minority women are at increased risk for postpartum weight retention (i.e.
      retaining weight after pregnancy) and consequent persistent obesity. Women who are obese
      pre-pregnancy are 3-5 times more likely to gain weight, rather than lose weight, in the
      postpartum period than non-obese women.

      Obesity science supports that weight loss interventions should be multi-component with
      regular points of contact. Building upon this, we have designed a multi-component
      intervention that considers the demands on women in the postpartum period and utilizes
      technology for both provider decision support and for virtual contact with participants. The
      intervention will address diet, physical activity, and social support through the use of
      in-person meetings with WIC staff, text messaging, phone coaching, self-monitoring, and
      Facebook.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a pilot, randomized controlled trial. The investigators will pilot a multi-component intervention delivered in a WIC (Women, Infants, children) setting.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Feasibility of Recruitment
time frame: Once the final participant is recruited
description: The investigators plan to determine the feasibility of recruitment for a weight loss intervention by evaluating the rate of recruitment. Below describes number recruited/enrolled over 14 weeks of recruitment
measure: Attrition Rate of Subjects Enrolled in the Study
time frame: Once the final participant completes the 12 week visit
description: The investigators will measure the number of dropouts/withdrawn once final participant has completed the 12 week visit.
measure: Visit Attendance
time frame: Baseline through Week 12, reported at Week 12
description: The investigators will measure lifestyle group participant attendance from enrollment through the 12-week visit. The number of participants who attended their visits is reported
measure: Acceptability of a Weight Loss Intervention
time frame: 12 weeks
description: To determine acceptability, investigators will use qualitative interviews to ask open-ended questions on this topic including asking participants in the intervention whether they would participate again. The number of participants interviewed who indicated that they would participate again is reported.
measure: Evaluation of the Use of Phone Coaching
time frame: 12 weeks
description: Investigators will count the total number of times any participant used phone coaching.
measure: Change in Weight Between Visits
time frame: Intervention group: Baseline, 12 weeks; Control group: Baseline and 12 weeks
description: To determine differences in change in weight between the intervention and control groups, participants will be weighed on a scale in the Women, Infants, and Children (WIC) setting.
measure: Changes in Diet: Intakes Measured in Grams
time frame: Baseline and 12 weeks
description: To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
measure: Changes in Physical Activity
time frame: Baseline and 12 weeks
description: To determine differences in total physical activity from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of the Pregnancy Physical Activity Questionnaire. This is a validated survey measure for physical activity.
measure: Changes in Diet and Physical Activity Self-efficacy
time frame: Baseline and 12 weeks
description: To determine differences in self-efficacy from baseline to 12 weeks between intervention and control groups, participants will complete an adapted version of Eating Habits Confidence Survey and Exercise Confidence Survey.
Diet self-efficacy: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.
Physical activity self-efficacy: Sticking to it scale: Possible range: -32 to 32; Higher scores indicate improved self-efficacy.
Making time scale: -12 to 12; Higher scores indicate improved self-efficacy.
measure: Changes in Motivations to Eat
time frame: Baseline and 12 weeks
description: To determine differences from baseline to12 weeks in motivations to eat between intervention and control groups, participants will complete the Eating Stimulus Index questionnaire.
Possible range = -92 to 92. Higher scores indicated improved lifestyle-related behaviors and motivations to eat.
measure: Changes in Readiness to Change
time frame: Baseline and 12 weeks
description: Investigators will evaluate any differences in readiness to change from baseline to 12 weeks between intervention and control groups by participants completing the Readiness to Change questionnaire. Possible range = -3 to 3; higher scores indicate greater change in readiness to change
measure: Changes in Diet: Intakes Measured in Cups
time frame: Baseline and 12 weeks
description: To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults. Fruit and vegetable intake changes are measured and reported in cups.
measure: Changes in Diet: kCal Intake
time frame: Baseline and 12 weeks
description: To determine differences in diet from baseline to 12 weeks between intervention and control groups, participants will complete the Block Fat-Sugar-Fruit-Vegetable Screener. This is a validated food screener for adults.
arm group label: Observational Group
arm group type: Experimental
description: Intervention: Participants will receive usual WIC care plus they will be given a packet of written WIC materials on lifestyle recommendations at the baseline visit, and offered an appointment with a WIC Registered Dietitian (RD) at the 12 week visit.
arm group label: Lifestyle Group
arm group type: Experimental
description: Intervention: Visits with WIC staff at Baseline, 4 weeks, 8 weeks: Meet with WIC staff who will use motivational interviewing during visits. Participants will complete an iPad app that asks lifestyle questions. Responses are provided to WIC staff in an easy to read format to guide lifestyle counseling and informational handouts are provided to participants.
In-between visits: Participants receive text messages with informational and motivational content. They are invited to a Facebook private group providing informational and motivational content and encouraging cross-support amongst participants. They are asked to self-monitor activity and weekly weights and will be offered weekly phone coaching appointments with WIC staff.
intervention type: Behavioral
intervention name: Observation Group participants
description: Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.
arm group label: Observational Group
intervention type: Behavioral
intervention name: Lifestyle group participants
description: Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
arm group label: Lifestyle Group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Darcy A Thompson, MD, MPH
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Loss
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 