<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/NCT02213393</url>
  </required_header>
  <id_info>
    <org_study_id>NL48893.081.14</org_study_id>
    <nct_id>NCT02213393</nct_id>
  </id_info>
  <brief_title>Cater With Care Effect Study</brief_title>
  <acronym>CwC</acronym>
  <official_title>Effectiveness of Cater With Care Products in Reaching Recommendations for Protein Intake During and After Hospital Stay and in Improving Functional Status After Hospital Stay in Elderly Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to study the effectiveness of supplementing a standard hospital and 12-week&#xD;
      home menu with protein-enriched Cater with Care products in reaching a protein intake of&#xD;
      1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in&#xD;
      elderly patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at&#xD;
      admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and oral&#xD;
      nutritional supplements if needed. Still, a considerable part of these patients are unable to&#xD;
      meet protein requirements and are still at risk of undernutrition at hospital discharge. This&#xD;
      may impair recovery of illness, partly due to loss of muscle mass and physical performance.&#xD;
      To improve protein intake, Cater with Care products have been developed: a selection of foods&#xD;
      and drinks that are consumed often by elderly persons, but now enriched with protein up to 10&#xD;
      grams per portion. We hypothesize that these products help to reach protein requirements in&#xD;
      elderly patients during and after hospital stay and thereby improve their health outcomes.&#xD;
&#xD;
      Objective: To study the effectiveness of supplementing a standard hospital and 12-week home&#xD;
      menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5&#xD;
      g/kg/day and in improving functional status after hospital stay in elderly patients.&#xD;
&#xD;
      Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a&#xD;
      hospital phase including all admitted patients and a home phase with a selection of patients.&#xD;
&#xD;
      Study population: Patients of 65 years or over who are admitted to the departments of&#xD;
      Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.&#xD;
&#xD;
      Intervention: The control group receives the standard hospital menu for elderly at risk of&#xD;
      undernutrition (energy and protein rich) and a variety of foods and drinks to be used as part&#xD;
      of their home diet for 12 weeks after hospitalization. Foods and drinks for home use are&#xD;
      non-enriched variants of Cater with Care products (e.g. normal fruit juice).&#xD;
&#xD;
      The intervention group receives Cater with Care protein-enriched foods and drinks during&#xD;
      hospital stay (in addition to the standard hospital menu) and at home as part of their home&#xD;
      diet for 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 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>Change from Baseline Protein intake and Physical functioning at 6 months</measure>
    <time_frame>6 months</time_frame>
    <description>This study has 2 primary outcomes: protein intake and physical functioning. These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in muscle strength from baseline to 6 months.</measure>
    <time_frame>6 months</time_frame>
    <description>Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nutritional status from baseline to 6 months.</measure>
    <time_frame>6 months</time_frame>
    <description>Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of Life from baseline to 6 months.</measure>
    <time_frame>6 months.</time_frame>
    <description>Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Activities of Daily Living from baseline to 6 months.</measure>
    <time_frame>6 months</time_frame>
    <description>Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>BMI</measure>
    <time_frame>6 months</time_frame>
    <description>BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.</description>
  </other_outcome>
  <other_outcome>
    <measure>Physical Activity</measure>
    <time_frame>6 months</time_frame>
    <description>Physical Activity will be assessed by using the LAPAQ questionnaire.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>12 weeks</time_frame>
    <description>The length of hospital stay will be recorded to include in an economic evaluation.</description>
  </other_outcome>
  <other_outcome>
    <measure>Costs of hospital stay</measure>
    <time_frame>12 weeks</time_frame>
    <description>After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Undernutrition</condition>
  <arm_group>
    <arm_group_label>Protein enriched products</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual menu</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Protein enriched products</intervention_name>
    <description>The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.</description>
    <arm_group_label>Protein enriched products</arm_group_label>
    <other_name>CwC products</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Usual menu</intervention_name>
    <description>The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.</description>
    <arm_group_label>Usual menu</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital phase:&#xD;
&#xD;
          -  admitted to the wards of Geriatric medicine, Pulmonary Medicine, or Internal Medicine&#xD;
             in Hospital Gelderse Vallei&#xD;
&#xD;
          -  aged 65 years or over&#xD;
&#xD;
          -  being eligible for receiving a standard protein enriched menu based on hospital&#xD;
             protocol&#xD;
&#xD;
          -  Home phase:&#xD;
&#xD;
          -  included in the hospital phase of the study&#xD;
&#xD;
          -  consent to continue treatment and study participation after hospital discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hospital phase:&#xD;
&#xD;
          -  unwilling to give consent for gathering data from the medical record or meal service&#xD;
             system&#xD;
&#xD;
          -  unable to understand Dutch&#xD;
&#xD;
          -  food allergies, food intolerances or other dietary restrictions that prevents the&#xD;
             patient from receiving the standard protein enriched menu or Cater with Care products&#xD;
             based on the judgement of a dietician and/or medical staff&#xD;
&#xD;
          -  expected length of hospital stay less than 4 days&#xD;
&#xD;
          -  renal insufficiency (eGFR &lt; 30 ml/min)&#xD;
&#xD;
          -  starting with tube feeding or total parenteral nutrition within 2 days of admission&#xD;
&#xD;
          -  refeeding syndrome score &gt; 0 based on hospital screening tool for refeeding risk&#xD;
&#xD;
          -  delirium at admission&#xD;
&#xD;
          -  receiving palliative care&#xD;
&#xD;
          -  Home phase:&#xD;
&#xD;
          -  going to a nursing home, rehabilitation centre or hospice after hospital discharge&#xD;
&#xD;
          -  cognitive impairment or diagnosed with dementia&#xD;
&#xD;
          -  legally incapacitated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole M de Roos, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Gelderse Vallei</name>
      <address>
        <city>Ede</city>
        <state>Gelderland</state>
        <zip>6716 RP</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>November 11, 2015</last_update_submitted>
  <last_update_submitted_qc>November 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>undernutrition</keyword>
  <keyword>nutritional status</keyword>
  <keyword>elderly patients</keyword>
  <keyword>protein</keyword>
  <keyword>enriched products</keyword>
  <keyword>recovery</keyword>
  <keyword>physical function</keyword>
  <keyword>quality of life</keyword>
  <keyword>activities of daily living</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malnutrition</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/NCT02213393
org study id: NL48893.081.14
nct id: NCT02213393
lead sponsor: 
has dmc: No
The objective is to study the effectiveness of supplementing a standard hospital and 12-week
      home menu with protein-enriched Cater with Care products in reaching a protein intake of
      1,2-1,5 g/kg body weight/day and in improving functional status after hospital stay in
      elderly patients.
Rationale: About 25% of hospitalized elderly patients are at risk of undernutrition at
      admission. Many hospitals provide an energy and protein enriched diet, extra snacks, and oral
      nutritional supplements if needed. Still, a considerable part of these patients are unable to
      meet protein requirements and are still at risk of undernutrition at hospital discharge. This
      may impair recovery of illness, partly due to loss of muscle mass and physical performance.
      To improve protein intake, Cater with Care products have been developed: a selection of foods
      and drinks that are consumed often by elderly persons, but now enriched with protein up to 10
      grams per portion. We hypothesize that these products help to reach protein requirements in
      elderly patients during and after hospital stay and thereby improve their health outcomes.

      Objective: To study the effectiveness of supplementing a standard hospital and 12-week home
      menu with protein-enriched Cater with Care products in reaching a protein intake of 1,2-1,5
      g/kg/day and in improving functional status after hospital stay in elderly patients.

      Study design: Randomised Controlled Trial (RCT) with 2 intervention groups and two phases: a
      hospital phase including all admitted patients and a home phase with a selection of patients.

      Study population: Patients of 65 years or over who are admitted to the departments of
      Geriatrics, Pulmonary Disease, or Internal Medicine of Hospital Gelderse Vallei.

      Intervention: The control group receives the standard hospital menu for elderly at risk of
      undernutrition (energy and protein rich) and a variety of foods and drinks to be used as part
      of their home diet for 12 weeks after hospitalization. Foods and drinks for home use are
      non-enriched variants of Cater with Care products (e.g. normal fruit juice).

      The intervention group receives Cater with Care protein-enriched foods and drinks during
      hospital stay (in addition to the standard hospital menu) and at home as part of their home
      diet for 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Protein intake and Physical functioning at 6 months
time frame: 6 months
description: This study has 2 primary outcomes: protein intake and physical functioning. These will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
measure: Change in muscle strength from baseline to 6 months.
time frame: 6 months
description: Muscle strength (leg and hand grip) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
measure: Change in nutritional status from baseline to 6 months.
time frame: 6 months
description: Nutritional status (MNA and dietary intake) will be assessed at baseline (0), and 2, 6, 12 and 24 weeks after hospital discharge.
measure: Change in Quality of Life from baseline to 6 months.
time frame: 6 months.
description: Quality of Life will be assessed with the EuroQoL-5D-5L (at baseline, and 12 and 24 weeks after hospital discharge)
measure: Change in Activities of Daily Living from baseline to 6 months.
time frame: 6 months
description: Activities of Daily Living (ADL) will be assessed by using the Barthel index (at baseline, and 2, 6, 12 and 24 weeks after hospital discharge).
measure: BMI
time frame: 6 months
description: BMI is calculated from weight and length measurements at baseline (0), 2, 6, 12, 24 weeks after hospital discharge.
measure: Physical Activity
time frame: 6 months
description: Physical Activity will be assessed by using the LAPAQ questionnaire.
measure: Length of hospital stay
time frame: 12 weeks
description: The length of hospital stay will be recorded to include in an economic evaluation.
measure: Costs of hospital stay
time frame: 12 weeks
description: After discharge from the hospital, the costs of hospital stay will be calculated to include in the economic evaluation.
arm group label: Protein enriched products
arm group type: Experimental
description: The intervention group receives protein enriched products (CwC products) in the hospital and receives these also after discharge during 12 weeks.
arm group label: Usual menu
arm group type: Active Comparator
description: The control group receives the usual protein and energy rich menu in the hospital and receives regular products, no protein enrichment, after discharge during 12 weeks.
intervention type: Dietary Supplement
intervention name: Protein enriched products
description: The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
arm group label: Protein enriched products
other name: CwC products
intervention type: Dietary Supplement
intervention name: Usual menu
description: The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.
arm group label: Usual menu
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Nicole M de Roos, PhD
role: Principal Investigator
affiliation: Wageningen University
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Malnutrition