<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/NCT03025048</url>
  </required_header>
  <id_info>
    <org_study_id>2016/1477-6</org_study_id>
    <nct_id>NCT03025048</nct_id>
  </id_info>
  <brief_title>A Holistic Dietary Intervention for Persons With Spinal Cord Injury</brief_title>
  <official_title>PILOT: A Holistic Dietary Intervention for Persons With Spinal Cord Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnaas Rehabilitation Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnaas Rehabilitation Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with spinal cord injury are at increased risk for overweight and obesity, type 2&#xD;
      diabetes, cardiovascular disease and decreased quality of life compared With able bodied.&#xD;
&#xD;
      This pilot aims to assess the impact of a nutrition intervention that combines several&#xD;
      methods to help people change their lifestyle.&#xD;
&#xD;
      The pilot project combines individual interviews and personal lifestyle goals (diet) with&#xD;
      group classes for people with long-standing spinal cord injury.&#xD;
&#xD;
      In addition to nutrition theory and practical exercises for diet-planning, motivational&#xD;
      interviewing and mindfullness are incorporated into the course. The course is&#xD;
      interdisciplinary, but is led primarily by a dietitian. Data is collected before the course&#xD;
      starts and right after the 9-week course ends. The measurements involves self-perceived&#xD;
      quality of life, food diary, weight, waist circumference and body composition (measured by&#xD;
      BIA and DXA).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 2016</start_date>
  <completion_date type="Actual">May 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Body composition</measure>
    <time_frame>Short-term: 9 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Diet behaviour</measure>
    <time_frame>Short-term: 9 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">13</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>A holistic dietary intervention for persons with spinal cord injury</intervention_name>
    <description>A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients With long-standing spinal cord injury (&gt; 2 years after injury)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt;18 years&#xD;
&#xD;
          -  Long-standing Spinal Cord Injury (&gt; 2 years after injury)&#xD;
&#xD;
          -  Motivated for lifestyle change&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>April 27, 2019</last_update_submitted>
  <last_update_submitted_qc>April 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnaas Rehabilitation Hospital</investigator_affiliation>
    <investigator_full_name>Hanne Bjørg Slettahjell</investigator_full_name>
    <investigator_title>Registered dietitian, MSc</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03025048
org study id: 2016/1477-6
nct id: NCT03025048
lead sponsor: 
has dmc: No
People with spinal cord injury are at increased risk for overweight and obesity, type 2
      diabetes, cardiovascular disease and decreased quality of life compared With able bodied.

      This pilot aims to assess the impact of a nutrition intervention that combines several
      methods to help people change their lifestyle.

      The pilot project combines individual interviews and personal lifestyle goals (diet) with
      group classes for people with long-standing spinal cord injury.

      In addition to nutrition theory and practical exercises for diet-planning, motivational
      interviewing and mindfullness are incorporated into the course. The course is
      interdisciplinary, but is led primarily by a dietitian. Data is collected before the course
      starts and right after the 9-week course ends. The measurements involves self-perceived
      quality of life, food diary, weight, waist circumference and body composition (measured by
      BIA and DXA).
observational model: Cohort
time perspective: Prospective
measure: Body composition
time frame: Short-term: 9 weeks
measure: Diet behaviour
time frame: Short-term: 9 weeks
intervention type: Behavioral
intervention name: A holistic dietary intervention for persons with spinal cord injury
description: A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Sunnaas Rehabilitation Hospital
investigator full name: Hanne Bjørg Slettahjell
investigator title: Registered dietitian, MSc
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries
sharing ipd: No