<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/NCT02229019</url>
  </required_header>
  <id_info>
    <org_study_id>MED1203</org_study_id>
    <secondary_id>14/LO/1363</secondary_id>
    <nct_id>NCT02229019</nct_id>
  </id_info>
  <brief_title>The Southampton Mealtime Assistance Roll-out Trial</brief_title>
  <acronym>SMART</acronym>
  <official_title>The Southampton Mealtime Assistance Roll-out Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Southampton NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical Research Council</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital Southampton NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Southampton Mealtime Assistance Study aims to determine whether it is feasible and&#xD;
      acceptable to introduce trained volunteers as mealtime assistants in five different&#xD;
      departments of one large hospital.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Feasibility and acceptability of volunteer mealtime assistants in different hospital departments</measure>
    <time_frame>16 months</time_frame>
    <description>Is it feasible to recruit and sustain sufficient volunteers to provide mealtime assistance across a large hospital trust? Are these volunteers acceptable to patients, relatives, and staff? This will be determined by recording the number of volunteers recruited, trained and assessed and by recording their activity, in numbers of mealtimes assisted per week and duration of volunteering. If a volunteer discontinues their role, the reasons will be identified for this.&#xD;
Acceptability will be assessed through qualitative methods- interviews with patients and relatives and focus groups with nursing staff and volunteers.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in food choice and dietary intake before and after the introduction of volunteer mealtime assistants</measure>
    <time_frame>16 months</time_frame>
    <description>The food choices and dietary intake of patients on the wards under study will be determined twice prior to the introduction of the volunteers and twice after their introduction. This will take place at the mealtime where the volunteers are assisting. The weight of meals served is portion controlled by the hospital caterers to within 10% of the stated weight. Therefore, using these stated weights and by measuring the leftover weight of food, we will calculate each patient's dietary intake at that mealtime.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Costs to the hospital trust associated with implementing a volunteer mealtime assistance programme</measure>
    <time_frame>16 months</time_frame>
    <description>Staff costs in terms of time spent training and supporting volunteers will be recorded, as will any consumables required for the study. The costs will be totalled to provide an overall cost estimate of implementing a volunteer mealtime assistance programme.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">258</enrollment>
  <condition>Volunteer Mealtime Assistants</condition>
  <arm_group>
    <arm_group_label>Volunteer mealtime assistance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Trained volunteers will provide mealtime assistance to older hospital inpatients at one mealtime each weekday.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Volunteer mealtime assistance</intervention_name>
    <arm_group_label>Volunteer mealtime assistance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over the age of 70 years admitted to one of the wards under study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with active bowel pathology&#xD;
&#xD;
          -  Patients in the terminal phase of their life&#xD;
&#xD;
          -  Patients who are artificially fed (parenterally or enterally)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fiona Rossiter, MBChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Southampton NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO21 3BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2014</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Volunteers</keyword>
  <keyword>Mealtime assistance</keyword>
  <keyword>Older adults</keyword>
  <keyword>Nutrition</keyword>
  <keyword>Nursing</keyword>
  <!-- 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/NCT02229019
org study id: MED1203
secondary id: 14/LO/1363
nct id: NCT02229019
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The Southampton Mealtime Assistance Study aims to determine whether it is feasible and
      acceptable to introduce trained volunteers as mealtime assistants in five different
      departments of one large hospital.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Feasibility and acceptability of volunteer mealtime assistants in different hospital departments
time frame: 16 months
description: Is it feasible to recruit and sustain sufficient volunteers to provide mealtime assistance across a large hospital trust? Are these volunteers acceptable to patients, relatives, and staff? This will be determined by recording the number of volunteers recruited, trained and assessed and by recording their activity, in numbers of mealtimes assisted per week and duration of volunteering. If a volunteer discontinues their role, the reasons will be identified for this.
Acceptability will be assessed through qualitative methods- interviews with patients and relatives and focus groups with nursing staff and volunteers.
measure: Changes in food choice and dietary intake before and after the introduction of volunteer mealtime assistants
time frame: 16 months
description: The food choices and dietary intake of patients on the wards under study will be determined twice prior to the introduction of the volunteers and twice after their introduction. This will take place at the mealtime where the volunteers are assisting. The weight of meals served is portion controlled by the hospital caterers to within 10% of the stated weight. Therefore, using these stated weights and by measuring the leftover weight of food, we will calculate each patient's dietary intake at that mealtime.
measure: Costs to the hospital trust associated with implementing a volunteer mealtime assistance programme
time frame: 16 months
description: Staff costs in terms of time spent training and supporting volunteers will be recorded, as will any consumables required for the study. The costs will be totalled to provide an overall cost estimate of implementing a volunteer mealtime assistance programme.
arm group label: Volunteer mealtime assistance
arm group type: Experimental
description: Trained volunteers will provide mealtime assistance to older hospital inpatients at one mealtime each weekday.
intervention type: Behavioral
intervention name: Volunteer mealtime assistance
arm group label: Volunteer mealtime assistance
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Fiona Rossiter, MBChB
role: Principal Investigator
affiliation: University Hospital Southampton NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor