<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/NCT02219763</url>
  </required_header>
  <id_info>
    <org_study_id>2014P001032</org_study_id>
    <nct_id>NCT02219763</nct_id>
  </id_info>
  <brief_title>The Effects of a Weight Management Program on Body Weight and Quality of Life</brief_title>
  <official_title>A Longitudinal Study to Investigate the Effects of a 14-visit Comprehensive Lifestyle Weight Management Program on Body Weight and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluate the impact of a 12-week behavioral weight management program on body weight and&#xD;
      quality of life. We hypothesize that participants will lose body weight and see improved&#xD;
      quality of life after program completion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate weight change and quality of life among individuals after completion&#xD;
      of a 12-week comprehensive group weight management program. Findings from this study will&#xD;
      also help with program development and improvement within our center. The already established&#xD;
      weight management program is called Healthy Habits for Life (HHL) and includes a total of 14&#xD;
      visits (one individual visit both before and after the 12 group sessions).&#xD;
&#xD;
      All patients who are enrolled in the Healthy Habits for Life group program at the Weight&#xD;
      Center have an individual visit with a registered dietitian prior to beginning the group as&#xD;
      part of standard care. At this visit the dietitian will obtain informed consent for&#xD;
      participation in the research study and provide subjects consenting to participate in the&#xD;
      study with the IWQOL-lite quality of life questionnaire.&#xD;
&#xD;
      After completion of the 12 HHL group sessions, all patients at the Weight Center have another&#xD;
      individual visit with the dietitian to review weight and behavior changes since the initial&#xD;
      evaluation. At this visit, subjects participating in the research study will again be&#xD;
      provided with the IWQOL-lite questionnaire to fill out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Weight Change</measure>
    <time_frame>Approximately 4 months after enrollment</time_frame>
    <description>The primary outcomes will be change in body weight comparing body weight at the start of the behavior change program and at the end. This includes weight at the initial individual visit, weights at each of the 12 group visits and body weight at the end of the group program.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>Approximately 4 months after enrollment</time_frame>
    <description>Quality of life will be assessed with a validated questionnaire at the start of the group and after completion of the group program.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Blood laboratory values</measure>
    <time_frame>Approximately 4 months after enrollment</time_frame>
    <description>Labs collected include: Albumin, Alkaline Phosphatase, Total Bilirubin, Total Protein, ALT, AST, HbA1C, Lipids and Insulin. These labs will be collected at a patients first visit to the Weight Center and again after completion of the group program.</description>
  </other_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Overweight</condition>
  <condition>Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adults (over age 18) with a BMI ≥ 25 enrolled in the 12-week Healthy Habits for Life (HHL)&#xD;
        group program from the MGH Weight Center will be recruited. Subjects will be recruited over&#xD;
        a 5-month period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking adults aged 18 or older&#xD;
&#xD;
          -  BMI ≥ 25&#xD;
&#xD;
          -  Enrolled in HHL program at the MGH Weight Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonja S Goedkoop, MSPH, RD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sonja S Goedkoop, MSPH, RD</last_name>
    <phone>617-726-6126</phone>
    <email>sgoedkoop@partners.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>MGH Weight Center, Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sonja S Goedkoop, MSPH, RD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2014</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>August 15, 2014</last_update_submitted>
  <last_update_submitted_qc>August 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 19, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Goedkoop, Sonja</investigator_full_name>
    <investigator_title>Registered Dietitian</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Overweight</mesh_term>
    <mesh_term>Body Weight</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/NCT02219763
org study id: 2014P001032
nct id: NCT02219763
lead sponsor: 
has dmc: Yes
Evaluate the impact of a 12-week behavioral weight management program on body weight and
      quality of life. We hypothesize that participants will lose body weight and see improved
      quality of life after program completion.
This study will evaluate weight change and quality of life among individuals after completion
      of a 12-week comprehensive group weight management program. Findings from this study will
      also help with program development and improvement within our center. The already established
      weight management program is called Healthy Habits for Life (HHL) and includes a total of 14
      visits (one individual visit both before and after the 12 group sessions).

      All patients who are enrolled in the Healthy Habits for Life group program at the Weight
      Center have an individual visit with a registered dietitian prior to beginning the group as
      part of standard care. At this visit the dietitian will obtain informed consent for
      participation in the research study and provide subjects consenting to participate in the
      study with the IWQOL-lite quality of life questionnaire.

      After completion of the 12 HHL group sessions, all patients at the Weight Center have another
      individual visit with the dietitian to review weight and behavior changes since the initial
      evaluation. At this visit, subjects participating in the research study will again be
      provided with the IWQOL-lite questionnaire to fill out.
observational model: Cohort
time perspective: Prospective
measure: Weight Change
time frame: Approximately 4 months after enrollment
description: The primary outcomes will be change in body weight comparing body weight at the start of the behavior change program and at the end. This includes weight at the initial individual visit, weights at each of the 12 group visits and body weight at the end of the group program.
measure: Quality of Life
time frame: Approximately 4 months after enrollment
description: Quality of life will be assessed with a validated questionnaire at the start of the group and after completion of the group program.
measure: Blood laboratory values
time frame: Approximately 4 months after enrollment
description: Labs collected include: Albumin, Alkaline Phosphatase, Total Bilirubin, Total Protein, ALT, AST, HbA1C, Lipids and Insulin. These labs will be collected at a patients first visit to the Weight Center and again after completion of the group program.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sonja S Goedkoop, MSPH, RD
role: Principal Investigator
affiliation: Massachusetts General Hospital
last name: Sonja S Goedkoop, MSPH, RD
phone: 617-726-6126
email: sgoedkoop@partners.org
facility: 
status: Recruiting
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Goedkoop, Sonja
investigator title: Registered Dietitian
mesh term: Overweight
mesh term: Body Weight