<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/NCT01662830</url>
  </required_header>
  <id_info>
    <org_study_id>MED 016</org_study_id>
    <nct_id>NCT01662830</nct_id>
  </id_info>
  <brief_title>A Retrospective Chart Review of Three Medifast Weight Control Centers</brief_title>
  <official_title>Use of the Medifast Meal Replacement Program for Weight Loss in Obese Patients: A Restrospective Chart Review of Three Medifast Weight Control Centers (MWCC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medifast, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medifast, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump&#xD;
      Start (Medifast's 5 &amp; 1) Plan on the following indices: weight loss, anthropometric changes,&#xD;
      and reduction in common markers of coronary heart disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Portion-controlled meal replacements by themselves have been shown to be an effective weight&#xD;
      control strategy in overweight and obese individuals. The addition of medical supervision has&#xD;
      been shown to result in greater weight loss than meal replacements alone. MWCC provides this&#xD;
      added support through individual weekly counseling sessions. Thus, the investigators plan to&#xD;
      retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 &amp; 1) Plan on the&#xD;
      following indices: weight loss, anthropometric changes, and reduction in common markers of&#xD;
      coronary heart disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">March 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in weight</measure>
    <time_frame>weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)</time_frame>
    <description>Weight loss (in pounds and percent weight loss) at weeks 4, 12, 24 and at final weight loss visit (average of 19.6 weeks).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in body composition</measure>
    <time_frame>weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)</time_frame>
    <description>changes in lean muscle mass, body fat mass, and body fat percent at weeks 4, 12, 24, and final weight loss visit(average of 19.6 weeks).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Compliance</measure>
    <time_frame>weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)</time_frame>
    <description>Compliance is measured by client attendance at weekly visits, consumption of meal replacements and dietary supplements, ketone testing, and completion of food journals</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention rates</measure>
    <time_frame>weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)</time_frame>
    <description>Retention of clients at specified time points (weeks 4, 12, 24 and final weight loss visit) and during the transition and weight maintenance phases of the MWCC weight management program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goal weight achievement</measure>
    <time_frame>Final weight loss visit (average of 19.6 weeks)</time_frame>
    <description>The percent of clients that achieve thier goal weight by their final weight loss visit(average of 19.6 weeks)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in abdominal circumference (inches)</measure>
    <time_frame>weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance of weight loss</measure>
    <time_frame>Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in cardiovascular risk factors</measure>
    <time_frame>weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)</time_frame>
    <description>Improvements in diastolic and systolic blood pressure and pulse at weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">446</enrollment>
  <condition>Obesity</condition>
  <arm_group>
    <arm_group_label>MWCC clients</arm_group_label>
    <description>This study will be a systematic retrospective chart review of clients participating in the Jump Start (5 &amp; 1) Plan at three different MWCC locations in Texas during the years 2007 - 2010.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This study was a systematic retrospective chart review of patients participating in the&#xD;
        Jump Start (5 &amp; 1) Plan at three different MWCC locations in Texas during the years&#xD;
        2007-2010.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult males and females aged 18-70&#xD;
&#xD;
          -  Followed the Jump Start (5 &amp; 1) Plan&#xD;
&#xD;
          -  BMI ≥ 25&#xD;
&#xD;
          -  Purchased a weight management program at the MWCC location in the last 3 years&#xD;
&#xD;
          -  Signed patient health information consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  On a plan other than the 5&amp;1 (Jump Start)&#xD;
&#xD;
          -  Completed initial consultation but did not participate further&#xD;
&#xD;
          -  Program stopped due to client not getting baseline labs&#xD;
&#xD;
          -  Program stopped due for medical reasons unrelated to the 5 &amp; 1 (Jump Start) plan&#xD;
&#xD;
          -  Currently an active participant at the MWCC&#xD;
&#xD;
          -  No signed patient health information consent form or written request to revoke consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.</citation>
    <PMID>12704397</PMID>
  </reference>
  <reference>
    <citation>Haddock CK, Poston WS, Foreyt JP, DiBartolomeo JJ, Warner PO. Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation. Eat Weight Disord. 2008 Jun;13(2):95-101. doi: 10.1007/BF03327609.</citation>
    <PMID>18612258</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 3, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <last_update_submitted>August 8, 2012</last_update_submitted>
  <last_update_submitted_qc>August 8, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 10, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Obesity</keyword>
  <keyword>Meal replacements</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</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/NCT01662830
org study id: MED 016
nct id: NCT01662830
lead sponsor: 
has dmc: No
The primary aim of this study is to to retrospectively evaluate the efficacy of the MWCC Jump
      Start (Medifast's 5 & 1) Plan on the following indices: weight loss, anthropometric changes,
      and reduction in common markers of coronary heart disease.
Portion-controlled meal replacements by themselves have been shown to be an effective weight
      control strategy in overweight and obese individuals. The addition of medical supervision has
      been shown to result in greater weight loss than meal replacements alone. MWCC provides this
      added support through individual weekly counseling sessions. Thus, the investigators plan to
      retrospectively evaluate the efficacy of the MWCC Jump Start (Medifast's 5 & 1) Plan on the
      following indices: weight loss, anthropometric changes, and reduction in common markers of
      coronary heart disease.
observational model: Case-Only
time perspective: Retrospective
measure: Changes in weight
time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
description: Weight loss (in pounds and percent weight loss) at weeks 4, 12, 24 and at final weight loss visit (average of 19.6 weeks).
measure: Changes in body composition
time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
description: changes in lean muscle mass, body fat mass, and body fat percent at weeks 4, 12, 24, and final weight loss visit(average of 19.6 weeks).
measure: Compliance
time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
description: Compliance is measured by client attendance at weekly visits, consumption of meal replacements and dietary supplements, ketone testing, and completion of food journals
measure: Retention rates
time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
description: Retention of clients at specified time points (weeks 4, 12, 24 and final weight loss visit) and during the transition and weight maintenance phases of the MWCC weight management program
measure: Goal weight achievement
time frame: Final weight loss visit (average of 19.6 weeks)
description: The percent of clients that achieve thier goal weight by their final weight loss visit(average of 19.6 weeks)
measure: Changes in abdominal circumference (inches)
time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
measure: Maintenance of weight loss
time frame: Following transition (up to 12 weeks) and maintenance (up to 52 weeks) phases of the program
measure: Changes in cardiovascular risk factors
time frame: weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks)
description: Improvements in diastolic and systolic blood pressure and pulse at weeks 4, 12, 24 and final weight loss visit (average of 19.6 weeks).
arm group label: MWCC clients
description: This study will be a systematic retrospective chart review of clients participating in the Jump Start (5 & 1) Plan at three different MWCC locations in Texas during the years 2007 - 2010.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
citation: Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258.
PMID: 12704397
citation: Haddock CK, Poston WS, Foreyt JP, DiBartolomeo JJ, Warner PO. Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation. Eat Weight Disord. 2008 Jun;13(2):95-101. doi: 10.1007/BF03327609.
PMID: 18612258
responsible party type: Sponsor
mesh term: Obesity