<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/NCT01724905</url>
  </required_header>
  <id_info>
    <org_study_id>18808</org_study_id>
    <nct_id>NCT01724905</nct_id>
  </id_info>
  <brief_title>Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)</brief_title>
  <official_title>Weight Loss and Maintenance for Individuals With Intellectual Developmental Disabilities (IDD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph Donnelly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed&#xD;
      those in the general population, consume energy dense diets, and perform very little physical&#xD;
      activity (PA). Overweight and obesity are independent risk factors for chronic disease such&#xD;
      as cancer, diabetes, hypertension, and cardiovascular disease in both the general population&#xD;
      and those with IDD.&#xD;
&#xD;
      The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged&#xD;
      meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and&#xD;
      vegetables (F/V) per week. The investigators will compare participants who use the SLDm with&#xD;
      participants who use a reduced energy and fat diet with meal plans, based off of the current&#xD;
      American Dietetic Association recommended car for weight reduction plan.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">May 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 between experimental diet (SLDm) and recommended care diet (RC)</measure>
    <time_frame>Change from Baseline in Weight at 6 months</time_frame>
    <description>The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Weight loss between experimental diet (SLDm) and recommended care diet (RC)</measure>
    <time_frame>Change from Baseline in Weight at 18 months</time_frame>
    <description>The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic disease factors - Blood Pressure</measure>
    <time_frame>Change from Baseline in Blood Pressure at 18 months</time_frame>
    <description>Changes in values of blood pressure between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic disease factors - Glucose</measure>
    <time_frame>Change from Baseline in Glucose at 18 months</time_frame>
    <description>Changes in values of glucose between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic disease factors - HDL</measure>
    <time_frame>Change from Baseline in HDL-cholesterol Pressure at 18 months</time_frame>
    <description>Changes in values of HDL-cholesterol between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic disease factors - LDL</measure>
    <time_frame>Change from Baseline in LDL-cholesterol Pressure at 18 months</time_frame>
    <description>Changes in values of LDL-cholesterol between the two groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of chronic disease factors - Insulin</measure>
    <time_frame>Change from Baseline in Insulin Pressure at 18 months</time_frame>
    <description>Changes in values of insulin between the two groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">151</enrollment>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Modified Stop Light Diet</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Recommended Care for Weight Reduction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Modified Stop Light Diet (SLDm)</intervention_name>
    <description>SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week</description>
    <arm_group_label>Modified Stop Light Diet</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Recommended Care Diet</intervention_name>
    <description>RC diet includes traditional meal plans and 35 fruits and vegetables per week</description>
    <arm_group_label>Recommended Care for Weight Reduction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of mile to moderate IDD as determined by a Community Service Provider&#xD;
             operating in Kansas under the auspices of a Community Developmental Disability&#xD;
             Organization (CDDO)&#xD;
&#xD;
          -  Able to understand and give informed consent&#xD;
&#xD;
          -  If there is a guardian with power of attorney, both the guardian and participant must&#xD;
             give informed consent&#xD;
&#xD;
          -  Participants must live in a supported living condition either at home or with no more&#xD;
             than 1-4 residents and have a care giver (ie. parent, staff) who assists with food&#xD;
             shopping, meal planning, and meal preparation&#xD;
&#xD;
          -  Overweight or obese determined by a BMI &gt; 25 kg/m2&#xD;
&#xD;
          -  Able to walk&#xD;
&#xD;
          -  Clearance provided from physician&#xD;
&#xD;
          -  Able to communicate preferences&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  Severe heart disease&#xD;
&#xD;
          -  Cancer diagnosis&#xD;
&#xD;
          -  Positive for HIV&#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>Joseph Donnelly, MD</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>December 2015</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 12, 2012</study_first_posted>
  <last_update_submitted>December 10, 2015</last_update_submitted>
  <last_update_submitted_qc>December 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 14, 2015</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>Joseph Donnelly</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Diet</keyword>
  <keyword>Obesity</keyword>
  <keyword>Chronic disease</keyword>
  <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>
    <mesh_term>Developmental Disabilities</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/NCT01724905
org study id: 18808
nct id: NCT01724905
lead sponsor: 
has dmc: Yes
Individuals with intellectual developmental disabilities (IDD) have obesity rates that exceed
      those in the general population, consume energy dense diets, and perform very little physical
      activity (PA). Overweight and obesity are independent risk factors for chronic disease such
      as cancer, diabetes, hypertension, and cardiovascular disease in both the general population
      and those with IDD.

      The investigators modified the Stop Light Diet (SLDm) to include reduced energy pre-packaged
      meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and
      vegetables (F/V) per week. The investigators will compare participants who use the SLDm with
      participants who use a reduced energy and fat diet with meal plans, based off of the current
      American Dietetic Association recommended car for weight reduction plan.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight loss between experimental diet (SLDm) and recommended care diet (RC)
time frame: Change from Baseline in Weight at 6 months
description: The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.
measure: Weight loss between experimental diet (SLDm) and recommended care diet (RC)
time frame: Change from Baseline in Weight at 18 months
description: The experimental diet is the Stop Light Diet modified (SLDm) and includes PM, 35 F/V per week, and low energy shakes. The Investigators will compare this to the RC diet that uses traditional meal plans and includes 35 F/V per week. Weight to be measured following an overnight fast of approximately 12 hours. Weight will be measured in kg. Each person will be weighed in a hospital gown between 8 and 10 am, using a calibrated scale to the nearest 0.1kg.
measure: Comparison of chronic disease factors - Blood Pressure
time frame: Change from Baseline in Blood Pressure at 18 months
description: Changes in values of blood pressure between the two groups
measure: Comparison of chronic disease factors - Glucose
time frame: Change from Baseline in Glucose at 18 months
description: Changes in values of glucose between the two groups
measure: Comparison of chronic disease factors - HDL
time frame: Change from Baseline in HDL-cholesterol Pressure at 18 months
description: Changes in values of HDL-cholesterol between the two groups
measure: Comparison of chronic disease factors - LDL
time frame: Change from Baseline in LDL-cholesterol Pressure at 18 months
description: Changes in values of LDL-cholesterol between the two groups
measure: Comparison of chronic disease factors - Insulin
time frame: Change from Baseline in Insulin Pressure at 18 months
description: Changes in values of insulin between the two groups
arm group label: Modified Stop Light Diet
arm group type: Experimental
arm group label: Recommended Care for Weight Reduction
arm group type: Active Comparator
intervention type: Dietary Supplement
intervention name: Modified Stop Light Diet (SLDm)
description: SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week
arm group label: Modified Stop Light Diet
intervention type: Dietary Supplement
intervention name: Recommended Care Diet
description: RC diet includes traditional meal plans and 35 fruits and vegetables per week
arm group label: Recommended Care for Weight Reduction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joseph Donnelly, MD
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: Joseph Donnelly
investigator title: Professor
mesh term: Body Weight
mesh term: Weight Loss
mesh term: Developmental Disabilities