<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/NCT02251587</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00001503</org_study_id>
    <nct_id>NCT02251587</nct_id>
  </id_info>
  <brief_title>The $Ensible Weight Program: An Intervention Tailored for Low Income Women</brief_title>
  <official_title>The $Ensible Weight Program: An Intervention Tailored for Low Income Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jeannine Goetz, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn if a weight loss program especially designed to address&#xD;
      food insecurity is more effective compared to a standard weight loss program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Low income women are at greater risk of both obesity and food insecurity (not having&#xD;
      consistent access to nutritious and adequate amounts of food). Most weight loss programs&#xD;
      targeted at low income women do not focus on gaining skills and knowledge to reduce food&#xD;
      insecurity.&#xD;
&#xD;
      Eligible participants will be randomized into one of two groups. The two groups will follow&#xD;
      different weight management programs. One group will follow a standard weight management&#xD;
      program. The other group with follow the investigations program, the $ensible Weigh Program.&#xD;
      Participation in the study will last about 9 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 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>Feasibility of implementing weight management program</measure>
    <time_frame>9 Months</time_frame>
    <description>Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Change from Baseline to Month 3</time_frame>
    <description>Change in weight during the weight loss phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight</measure>
    <time_frame>Change from Month 3 to Month 9</time_frame>
    <description>Change in weight during the weight management phase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diet quality</measure>
    <time_frame>Change from Baseline to Month 3</time_frame>
    <description>Change during the weight loss phase. Change will be measured based on questions answered about participant's diet quality. Changes measured based on lower percentage of calories from fat and increased consumption of fruits, vegetables and whole grains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in diet quality</measure>
    <time_frame>Change from Month 3 to Month 9</time_frame>
    <description>Change during the weight management phase. Change will be measured based on questions answered about participant's diet quality. Changes measured based on lower percentage of calories from fat and increased consumption of fruits, vegetables and whole grains.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food security status</measure>
    <time_frame>Change from Baseline to Month 3</time_frame>
    <description>Change during the weight loss phase. Change will be measured based upon responses to the US Household Food Security Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in food security status</measure>
    <time_frame>Change from Month 3 to Month 9</time_frame>
    <description>Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Standard Weight Management Program</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will be given information on diet and exercise. Participants will attend meetings to discuss barriers to exercise and nutrition and ways to solve these problems. Participants will be given healthy snack ideas and planning tools.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>$ensible Weigh Program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be given information on diet and exercise with an emphasis on food security. Participants will be provided with additional information on community resources such as those for food, transportation, and safe places to exercise. A weekly cooking demonstration will be provided using inexpensive ingredients and common food pantry items.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Weight Management Program</intervention_name>
    <description>Standard Diet program based on diet and exercise.</description>
    <arm_group_label>Standard Weight Management Program</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sensible Weigh Program</intervention_name>
    <description>Weight loss program designed for low income women.</description>
    <arm_group_label>$ensible Weigh Program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented low income&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;25.0 kg/m2&#xD;
&#xD;
          -  Must speak and understand English&#xD;
&#xD;
          -  Able to attend intervention sessions and have access to telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Report serious medical risk such as insulin-dependent diabetes, cancer, recent cardiac&#xD;
             event&#xD;
&#xD;
          -  Currently or planning to become pregnant during the intervention&#xD;
&#xD;
          -  Have no control over food purchases or choices&#xD;
&#xD;
          -  Report participation in a weight reduction program involving diet or PA within past 6&#xD;
             months&#xD;
&#xD;
          -  Report symptomology of an eating disorder&#xD;
&#xD;
          -  Report adherence to specialized diet regimes, i.e., multiple food allergies,&#xD;
             vegetarian, Atkins, macrobiotic, etc.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Months</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeannine Goetz, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>February 2, 2016</last_update_submitted>
  <last_update_submitted_qc>February 2, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Jeannine Goetz, PhD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Weight</mesh_term>
    <mesh_term>Weight Loss</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/NCT02251587
org study id: STUDY00001503
nct id: NCT02251587
lead sponsor: 
has dmc: No
The purpose of this study is to learn if a weight loss program especially designed to address
      food insecurity is more effective compared to a standard weight loss program.
Low income women are at greater risk of both obesity and food insecurity (not having
      consistent access to nutritious and adequate amounts of food). Most weight loss programs
      targeted at low income women do not focus on gaining skills and knowledge to reduce food
      insecurity.

      Eligible participants will be randomized into one of two groups. The two groups will follow
      different weight management programs. One group will follow a standard weight management
      program. The other group with follow the investigations program, the $ensible Weigh Program.
      Participation in the study will last about 9 months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility of implementing weight management program
time frame: 9 Months
description: Feasibility assessed by participant retention, participant attendance at study related visits, and participant satisfaction.
measure: Change in weight
time frame: Change from Baseline to Month 3
description: Change in weight during the weight loss phase
measure: Change in weight
time frame: Change from Month 3 to Month 9
description: Change in weight during the weight management phase
measure: Change in diet quality
time frame: Change from Baseline to Month 3
description: Change during the weight loss phase. Change will be measured based on questions answered about participant's diet quality. Changes measured based on lower percentage of calories from fat and increased consumption of fruits, vegetables and whole grains.
measure: Change in diet quality
time frame: Change from Month 3 to Month 9
description: Change during the weight management phase. Change will be measured based on questions answered about participant's diet quality. Changes measured based on lower percentage of calories from fat and increased consumption of fruits, vegetables and whole grains.
measure: Change in food security status
time frame: Change from Baseline to Month 3
description: Change during the weight loss phase. Change will be measured based upon responses to the US Household Food Security Questionnaire
measure: Change in food security status
time frame: Change from Month 3 to Month 9
description: Change during the weight maintenance phase. Change will be measured based upon responses to the US Household Food Security Questionnaire
arm group label: Standard Weight Management Program
arm group type: Active Comparator
description: Participants will be given information on diet and exercise. Participants will attend meetings to discuss barriers to exercise and nutrition and ways to solve these problems. Participants will be given healthy snack ideas and planning tools.
arm group label: $ensible Weigh Program
arm group type: Experimental
description: Participants will be given information on diet and exercise with an emphasis on food security. Participants will be provided with additional information on community resources such as those for food, transportation, and safe places to exercise. A weekly cooking demonstration will be provided using inexpensive ingredients and common food pantry items.
intervention type: Other
intervention name: Standard Weight Management Program
description: Standard Diet program based on diet and exercise.
arm group label: Standard Weight Management Program
intervention type: Other
intervention name: Sensible Weigh Program
description: Weight loss program designed for low income women.
arm group label: $ensible Weigh Program
criteria: 
gender: Female
minimum age: 21 Months
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeannine Goetz, PhD
role: Principal Investigator
affiliation: University of Kansas Medical Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Jeannine Goetz, PhD
investigator title: Assistant Professor
mesh term: Body Weight
mesh term: Weight Loss