<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/NCT04436692</url>
  </required_header>
  <id_info>
    <org_study_id>Department of Nutrition</org_study_id>
    <nct_id>NCT04436692</nct_id>
  </id_info>
  <brief_title>Dietary Intervention and Adults With Intellectual Disabilities</brief_title>
  <official_title>Dietary Intervention in Overweight Subjects With Intellectual Disabilties Using the Nudging Approach as Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Oslo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Oslo</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Goal The overall aim of the study is to improve the health of persons with Intellectual&#xD;
      disabilities&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose&#xD;
&#xD;
      There are two main purposes of the study The first is to study the diet and heath of persons&#xD;
      with intellectual disabilities. The second is to increase their knowledge on nutrition and&#xD;
      health and that of service providers in municipalities housing facilities and to test, in an&#xD;
      intervention, the effects of a method for weight reduction in adult persons with intellectual&#xD;
      disabilities with overweight and obesity. Physical activity is also an important factor in&#xD;
      weight reduction, but this study focuses only on nutrition, to obtain new information on this&#xD;
      one factor in weight reduction. A combined study with many changes in a short period of time&#xD;
      is very challenging for the group in question.&#xD;
&#xD;
      The vision is that results from this study will lead to improved health promotive and&#xD;
      preventive services in the municipality in the future, to adult persons with intellectual&#xD;
      disabilities and that this study also can have effects on services also for other groups,&#xD;
      such as those with the fields of psychiatry and drug problems.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in body weight by using a nudging approach in adults with intellectual disabilities</measure>
    <time_frame>One year</time_frame>
    <description>2 kg weight decrease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in consumption of fruits and vegetables as measured using dietary survey</measure>
    <time_frame>One year</time_frame>
    <description>Dietary change 1</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in consumption of sugar containing beverages as measured using dietary survey</measure>
    <time_frame>One year</time_frame>
    <description>Dietary change 2</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Intellectual Disabilities Nutritional</condition>
  <condition>Intellectual Disability</condition>
  <arm_group>
    <arm_group_label>Improve dietary pattern</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nudging</intervention_name>
    <description>Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables</description>
    <arm_group_label>Improve dietary pattern</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Mild intellectual disability and overweight&#xD;
&#xD;
          -  Moderate intellectual disability and overweight&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metabolic diseases&#xD;
&#xD;
          -  Hypertension&#xD;
&#xD;
          -  Diabetes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lene F Andersen, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Institute of Basic Medical Sciences</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Svein O Kolset, PhD</last_name>
    <phone>+47 22851383</phone>
    <email>s.o.kolset@medisin.uio.no</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marianne Nordstrøm, PhD</last_name>
    <phone>+4764856047</phone>
    <email>marianne.nordstrom@frambu.no</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Oslo</name>
      <address>
        <city>Oslo</city>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helel K Røstad-Tollefsen, MSc</last_name>
      <phone>+4799011566</phone>
      <email>helen.k.r.tollefsen@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 5, 2022</last_update_submitted>
  <last_update_submitted_qc>April 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Oslo</investigator_affiliation>
    <investigator_full_name>Svein Olav Kolset</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intellectual Disability</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/NCT04436692
org study id: Department of Nutrition
nct id: NCT04436692
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Goal The overall aim of the study is to improve the health of persons with Intellectual
      disabilities
Purpose

      There are two main purposes of the study The first is to study the diet and heath of persons
      with intellectual disabilities. The second is to increase their knowledge on nutrition and
      health and that of service providers in municipalities housing facilities and to test, in an
      intervention, the effects of a method for weight reduction in adult persons with intellectual
      disabilities with overweight and obesity. Physical activity is also an important factor in
      weight reduction, but this study focuses only on nutrition, to obtain new information on this
      one factor in weight reduction. A combined study with many changes in a short period of time
      is very challenging for the group in question.

      The vision is that results from this study will lead to improved health promotive and
      preventive services in the municipality in the future, to adult persons with intellectual
      disabilities and that this study also can have effects on services also for other groups,
      such as those with the fields of psychiatry and drug problems.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Change in body weight by using a nudging approach in adults with intellectual disabilities
time frame: One year
description: 2 kg weight decrease
measure: Change in consumption of fruits and vegetables as measured using dietary survey
time frame: One year
description: Dietary change 1
measure: Change in consumption of sugar containing beverages as measured using dietary survey
time frame: One year
description: Dietary change 2
arm group label: Improve dietary pattern
arm group type: Other
description: Nudging approach to test this methodological approach in persons with intellectual disabilitites with goal to improve dietary pattern and loss of weight
intervention type: Behavioral
intervention name: Nudging
description: Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables
arm group label: Improve dietary pattern
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Lene F Andersen, PhD
role: Study Chair
affiliation: Institute of Basic Medical Sciences
last name: Svein O Kolset, PhD
phone: +47 22851383
email: s.o.kolset@medisin.uio.no
last name: Marianne Nordstrøm, PhD
phone: +4764856047
email: marianne.nordstrom@frambu.no
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: University of Oslo
investigator full name: Svein Olav Kolset
investigator title: Professor
mesh term: Intellectual Disability