<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/NCT01668316</url>
  </required_header>
  <id_info>
    <org_study_id>GEM-12-0059</org_study_id>
    <nct_id>NCT01668316</nct_id>
  </id_info>
  <brief_title>Get Active and Eat Right: Moms at Work</brief_title>
  <acronym>GEM</acronym>
  <official_title>Get Active and Eat Right: Moms at Work</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Greensboro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Greensboro</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the effectiveness of a worksite diet and exercise&#xD;
      program on weight loss in postpartum women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project is a research study investigating the effects of a worksite diet and exercise&#xD;
      intervention on weight loss in overweight postpartum women. Weight loss programs have been&#xD;
      shown to be effective in reducing postpartum weight retention. However, high attrition rates&#xD;
      in these studies suggest that the added responsibility of a new infant at home and returning&#xD;
      to work may limit a woman's ability to follow a diet plan and exercise regularly. We hope&#xD;
      that by offering a weight loss program at the workplace, we can increase participant&#xD;
      retention and maximize weight loss in this population. Our primary aim is to promote weight&#xD;
      loss while preserving lean body mass during the 12 week intervention. Secondary aims include&#xD;
      increasing cardiovascular fitness from baseline and improving cardiovascular biomarkers,&#xD;
      including total, LDL, and HDL cholesterol, triglycerides, glucose, insulin, and markers of&#xD;
      inflammation and metabolism.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">December 21, 2015</completion_date>
  <primary_completion_date type="Actual">December 21, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss and change in body composition</measure>
    <time_frame>12 weeks</time_frame>
    <description>We will be measuring change in weight, waist and hip circumference, and body fat percentage to assess the degree of weight loss and change in body composition at baseline and after the 12 week intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">34</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Weight loss</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12 week weight loss program with biweekly meetings with a Registered Dietitian. Participants will be given a nutrition prescription and asked to record dietary intake online. Participants will be given a pedometer and record daily physical activity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants asked to not change dietary and physical activity habits.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Weight loss</intervention_name>
    <description>Participants will be prescribed a reduced calorie diet and asked to track their diet three days per week using the online USDA MyPlate SuperTracker. This record will be accessed by the RD in order to provide diet recommendations sent by email.&#xD;
Participants will be given an exercise prescription, and encouraged to walk briskly with a provided pedometer or exercise at the campus Recreation Center every day. Participants will be asked to record the number of steps and other physical activity in a log book.&#xD;
Participants will meet with the research staff every other week to measure weight, waist and hip circumference, and record the steps from the pedometer.&#xD;
Participants will be encouraged to breastfeed their baby and provided with resources for pumping breast milk at work.</description>
    <arm_group_label>Weight loss</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older, 10 to 14 weeks postpartum, University faculty, staff, and&#xD;
             students, BMI 25-35 or at least 4.5 kilograms heavier than prepregnancy weight,&#xD;
             English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smoking, chronic disease, BMI &gt;35&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cheryl Lovelady, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Greensboro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Greensboro</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of North Carolina, Greensboro</investigator_affiliation>
    <investigator_full_name>Cheryl A Lovelady, PhD RD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Overweight</keyword>
  <keyword>Obese</keyword>
  <keyword>Postpartum</keyword>
  <keyword>Weight loss</keyword>
  <keyword>Inflammation</keyword>
  <keyword>Obesity</keyword>
  <keyword>Cardiovascular</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01668316
org study id: GEM-12-0059
nct id: NCT01668316
lead sponsor: 
The purpose of this study is to determine the effectiveness of a worksite diet and exercise
      program on weight loss in postpartum women.
This project is a research study investigating the effects of a worksite diet and exercise
      intervention on weight loss in overweight postpartum women. Weight loss programs have been
      shown to be effective in reducing postpartum weight retention. However, high attrition rates
      in these studies suggest that the added responsibility of a new infant at home and returning
      to work may limit a woman's ability to follow a diet plan and exercise regularly. We hope
      that by offering a weight loss program at the workplace, we can increase participant
      retention and maximize weight loss in this population. Our primary aim is to promote weight
      loss while preserving lean body mass during the 12 week intervention. Secondary aims include
      increasing cardiovascular fitness from baseline and improving cardiovascular biomarkers,
      including total, LDL, and HDL cholesterol, triglycerides, glucose, insulin, and markers of
      inflammation and metabolism.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight loss and change in body composition
time frame: 12 weeks
description: We will be measuring change in weight, waist and hip circumference, and body fat percentage to assess the degree of weight loss and change in body composition at baseline and after the 12 week intervention.
measure: Cholesterol
time frame: 12 weeks
description: We will be measuring changes in total cholesterol, LDL, and HDL at baseline and after the 12 week intervention.
arm group label: Weight loss
arm group type: Experimental
description: 12 week weight loss program with biweekly meetings with a Registered Dietitian. Participants will be given a nutrition prescription and asked to record dietary intake online. Participants will be given a pedometer and record daily physical activity.
arm group label: Control
arm group type: No Intervention
description: Participants asked to not change dietary and physical activity habits.
intervention type: Behavioral
intervention name: Weight loss
description: Participants will be prescribed a reduced calorie diet and asked to track their diet three days per week using the online USDA MyPlate SuperTracker. This record will be accessed by the RD in order to provide diet recommendations sent by email.
Participants will be given an exercise prescription, and encouraged to walk briskly with a provided pedometer or exercise at the campus Recreation Center every day. Participants will be asked to record the number of steps and other physical activity in a log book.
Participants will meet with the research staff every other week to measure weight, waist and hip circumference, and record the steps from the pedometer.
Participants will be encouraged to breastfeed their baby and provided with resources for pumping breast milk at work.
arm group label: Weight loss
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Cheryl Lovelady, PhD
role: Principal Investigator
affiliation: University of North Carolina, Greensboro
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of North Carolina, Greensboro
investigator full name: Cheryl A Lovelady, PhD RD
investigator title: Professor
mesh term: Overweight