<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/NCT01671397</url>
  </required_header>
  <id_info>
    <org_study_id>041923</org_study_id>
    <nct_id>NCT01671397</nct_id>
  </id_info>
  <brief_title>Women's Health Project for Women Wanting to Lose Weight</brief_title>
  <official_title>Intervention Study in Women Wanting to Lose Weight (Women's Health Project)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Texas Tech University Health Sciences Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Texas Tech University Health Sciences Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of obesity has steadily increased in the United States. This can lead to the&#xD;
      worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and&#xD;
      osteoarthritis. The medical management of obesity involves dietary counseling and education,&#xD;
      behavioral counseling with goal setting, and exercise. Patients with short sleep periods in&#xD;
      the range of 5 to 7 hours per night are often heavier than normal sleepers even after&#xD;
      controlling for other factors. We hypothesize that the addition of focused counseling on&#xD;
      healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help&#xD;
      women lose weight.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      None needed&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight loss</measure>
    <time_frame>Six months</time_frame>
    <description>Patients will be monitored for weight loss over a six month study period. We estimate that the sleep hygiene intervention group will lose 10 pounds more than the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional capacity</measure>
    <time_frame>6 months</time_frame>
    <description>We will measure functional capacity using gait speed, timed &quot;Get-up and Go&quot; test, and standing balance at baseline and at six months.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Lipid profile</measure>
    <time_frame>Six months</time_frame>
    <description>We will measure cholesterol, LDL, HDL, triglycerides, and hemoglobin A 1 c at baseline and six months.</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life indices</measure>
    <time_frame>Six months</time_frame>
    <description>We will measure quality of life indices using questionnaires at baseline and six months.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>Diet, exercise, sleep hygiene counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will meet with a dietitian and a physician and receive counseling on diet restriction, exercise goals, and good sleep hygiene. Subjects will identify goals in each domain and keep a calendar of the success with achieving these goals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Diet and exercise counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects will meet with a dietitian and a physician and receive counseling on calorie restriction and exercise. They will identify goals in each domain and keep a calendar to determine their success with achieving these goals.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet and exercise counseling</intervention_name>
    <description>Not needed</description>
    <arm_group_label>Diet and exercise counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Diet, exercise, sleep hygiene counseling</intervention_name>
    <description>None needed</description>
    <arm_group_label>Diet, exercise, sleep hygiene counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any woman between the ages of 18 and 70 who is interested in counseling for weight&#xD;
             loss&#xD;
&#xD;
          -  The body mass index (BMI) must be over 25 (overweight category) and below 40 (morbidly&#xD;
             obese)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women who cannot reasonably expect to commit the time needed for 6 visits, two lab&#xD;
             draws, and completion of three one week sleep logs&#xD;
&#xD;
          -  Women who have had recent hospitalization or major surgery and cannot participate in a&#xD;
             self directed exercise program&#xD;
&#xD;
          -  Women with significant cardiac or respiratory disease and cannot participate in a self&#xD;
             directed exercise program&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth M Nugent, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Tech University Health Sciences Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dolores M Buscemi, MD</last_name>
    <role>Study Director</role>
    <affiliation>Texas Tech University Health Sciences Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Tech Health Sciences Center - Physicians Pavillion, Internal Medicine Clinic</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79430</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>April 30, 2014</last_update_submitted>
  <last_update_submitted_qc>April 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>weight loss</keyword>
  <keyword>sleep hygiene</keyword>
  <keyword>diet</keyword>
  <keyword>exercise</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Weight Loss</mesh_term>
  </condition_browse>
  <!-- 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/NCT01671397
org study id: 041923
nct id: NCT01671397
lead sponsor: 
has dmc: No
The prevalence of obesity has steadily increased in the United States. This can lead to the
      worsening of type 2 diabetes mellitus, hypertension, sleep apnea, coronary artery disease and
      osteoarthritis. The medical management of obesity involves dietary counseling and education,
      behavioral counseling with goal setting, and exercise. Patients with short sleep periods in
      the range of 5 to 7 hours per night are often heavier than normal sleepers even after
      controlling for other factors. We hypothesize that the addition of focused counseling on
      healthy sleeping to counseling on healthy eating (dieting) and healthy exercise can help
      women lose weight.
None needed
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Weight loss
time frame: Six months
description: Patients will be monitored for weight loss over a six month study period. We estimate that the sleep hygiene intervention group will lose 10 pounds more than the control group.
measure: Functional capacity
time frame: 6 months
description: We will measure functional capacity using gait speed, timed "Get-up and Go" test, and standing balance at baseline and at six months.
measure: Lipid profile
time frame: Six months
description: We will measure cholesterol, LDL, HDL, triglycerides, and hemoglobin A 1 c at baseline and six months.
measure: Quality of life indices
time frame: Six months
description: We will measure quality of life indices using questionnaires at baseline and six months.
arm group label: Diet, exercise, sleep hygiene counseling
arm group type: Experimental
description: Subjects will meet with a dietitian and a physician and receive counseling on diet restriction, exercise goals, and good sleep hygiene. Subjects will identify goals in each domain and keep a calendar of the success with achieving these goals.
arm group label: Diet and exercise counseling
arm group type: Active Comparator
description: Subjects will meet with a dietitian and a physician and receive counseling on calorie restriction and exercise. They will identify goals in each domain and keep a calendar to determine their success with achieving these goals.
intervention type: Behavioral
intervention name: Diet and exercise counseling
description: Not needed
arm group label: Diet and exercise counseling
intervention type: Behavioral
intervention name: Diet, exercise, sleep hygiene counseling
description: None needed
arm group label: Diet, exercise, sleep hygiene counseling
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kenneth M Nugent, MD
role: Principal Investigator
affiliation: Texas Tech University Health Sciences Center
last name: Dolores M Buscemi, MD
role: Study Director
affiliation: Texas Tech University Health Sciences Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Weight Loss