<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/NCT04445883</url>
  </required_header>
  <id_info>
    <org_study_id>JosephBrantH</org_study_id>
    <nct_id>NCT04445883</nct_id>
  </id_info>
  <brief_title>Evaluating the Impact of the Eating Matters Program on the Nutritional Status of Elderly Patients at Joseph Brant Hospital</brief_title>
  <acronym>JBH</acronym>
  <official_title>Evaluating the Impact of a Volunteer Based Mealtime Assistance Program on the Nutritional Status of Elderly Patients at Joseph Brant Hospital in Ontario, Canada</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Joseph Brant Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Compass Group Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Joseph Brant Hospital</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>
      This research study will determine the impact of the Eating Matters Program on the&#xD;
      nutritional status of elderly patients at Joseph Brant Hospital. The Eating Matters Program&#xD;
      at Joseph Brant Hospital is a volunteer-based feeding assistance program that aims to improve&#xD;
      patients' nutritional intake by providing assistance during mealtimes. As research on the&#xD;
      impact of such programs on food intake is limited in Canada, this study will explore how the&#xD;
      Eating Matters Program influences protein and energy intake of patients at Joseph Brant&#xD;
      Hospital. Further, this study will explore if the hypothesized increase in protein and energy&#xD;
      intake with the initiation of the Eating Matters Program is correlated with a decreased risk&#xD;
      of malnutrition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will be conducting a prospective open-label non-randomized controlled trial to evaluate&#xD;
      patients' nutritional outcomes in units that have the Eating Matters Program available (Study&#xD;
      Group A) vs. similar units that do not have this program (Control Group B), as this can&#xD;
      provide useful data on the effectiveness of such programs in developing innovative prevention&#xD;
      strategies to address hospital malnutrition.&#xD;
&#xD;
      A total sample size of eighty participants (40 in each group) will be included in this study&#xD;
      from Medical and Rehabilitation units at Joseph Brant Hospital. Study group A will include&#xD;
      patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Control&#xD;
      Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200.&#xD;
      Baseline food intake data (including breakfast, lunch and dinner) will be gathered during a&#xD;
      2-day period for both Study Group A and Control Group B. Following the collection of baseline&#xD;
      data, feeding assistance will then be provided to participants in the units that have the EMP&#xD;
      program available (6S100 and 6N400/500). In addition, food intake will be recorded for a&#xD;
      total of 6 days for both Study Group A, and Control Group B. Outcome measures including&#xD;
      C-reactive protein and weight will be measured weekly. Following, a Subjective Global&#xD;
      Assessment (SGA) will be completed and Hand Grip Strength will be recorded on days 1 and 18&#xD;
      as the literature shows that this is an appropriate timeframe to reassess these measures&#xD;
      (Flood et al., 2014; Canadian Malnutrition Task Force, 2019). Energy and protein intake will&#xD;
      then be calculated using visual estimation by completion of the My Meal Intake Tool, and the&#xD;
      hospital's CBORD software. Further, to evaluate the success of the feeding assistance&#xD;
      program, volunteers will distribute the feedback survey to patients, staff, family members or&#xD;
      friends of participants. To prevent contamination from staff working on both sides, members&#xD;
      of the research team will have a discussion with staff to explain that the study and&#xD;
      potential benefits should not be discussed, as this may impact the research findings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">June 1, 2023</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The investigators will be evaluating patients' nutritional outcomes in units that have the Eating Matters Program available vs. similar units that do not have this program. Therefore, there will be two groups, Study Group A and Control Group B.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary Intake</measure>
    <time_frame>To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days).</time_frame>
    <description>Protein and Energy Intake</description>
  </primary_outcome>
  <other_outcome>
    <measure>Percent weight change</measure>
    <time_frame>A change from baseline body weight at 1 week and 2 weeks marks (+/-2) days post the initiation of the Eating Matters Program (EMP).</time_frame>
    <description>Participants' weight will be measured.</description>
  </other_outcome>
  <other_outcome>
    <measure>Handgrip strength</measure>
    <time_frame>A change from baselines in handgrip measure at 1 and 2 weeks marks (+/-2 days) post the initiation of EMP.</time_frame>
    <description>Handgrip strength measured using hand dynamometers.</description>
  </other_outcome>
  <other_outcome>
    <measure>C-Reactive Protein</measure>
    <time_frame>A change from baselines CRP at 1 week and 2 weeks marks (+/-2 days) post the initiation of EMP.</time_frame>
    <description>C-Reactive Protein will be measured via routine lab work.</description>
  </other_outcome>
  <other_outcome>
    <measure>Eating Matters Program Feedback</measure>
    <time_frame>This will be measured on day 19 (+/-2 days) (total study period for each participant).</time_frame>
    <description>Perceptions of program implementation and Barriers to food intake will be evaluated via feedback forms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Length of stay</measure>
    <time_frame>This data will be gathered on day 120 (+/-2days), upon completion of the study.</time_frame>
    <description>Unit Specific Measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Mortality rate</measure>
    <time_frame>This data will be gathered on day 120 (+/- 2days), upon completion of the study.</time_frame>
    <description>Unit Specific Measure</description>
  </other_outcome>
  <other_outcome>
    <measure>Re-admission rate</measure>
    <time_frame>This data will be gathered on day 120 (+/- 2 days), upon completion of the study.</time_frame>
    <description>Unit Specific Measure</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Food Habits</condition>
  <arm_group>
    <arm_group_label>Study Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study group A will include patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Participants in Study Group A will be receiving mealtime assistance from volunteers via the Eating Matters Program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Feeding Assistance</intervention_name>
    <description>Patients will be receiving assistance during mealtimes. This includes assistance by opening packages, listing/explaining the food products on the tray, providing encouragement and companionship during mealtimes and directly feed patients.</description>
    <arm_group_label>Study Group A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 65 years and over admitted to Medicine and Rehabilitation units at Joseph&#xD;
             Brant Hospital with an anticipated stay 10-14 days&#xD;
&#xD;
          -  Patients with a Subjective Global Assessment score of B or C, and identified to&#xD;
             require eating assistance&#xD;
&#xD;
          -  Patients able to provide consent or have a Power of Attorney to do so on their behalf&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that are NPO status (nothing by mouth)&#xD;
&#xD;
          -  Patients that require enteral or total parenteral feeding&#xD;
&#xD;
          -  Palliative care patients&#xD;
&#xD;
          -  Severe cognitive impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.albertahealthservices.ca/nutrition/Page16003.aspx</url>
    <description>Time to Eat Toolkit. Retrieved from Alberta Health Services</description>
  </link>
  <link>
    <url>https://nutritioncareincanada.ca/sites/default/uploads/files/INPAC-Toolkit-FINAL-Dec5-2017.pdf</url>
    <description>Integrated Nutrition Pathway for Acute Care (INPAC) Implementation Toolkit</description>
  </link>
  <link>
    <url>https://nutritioncareincanada.ca/resources-and-tools/hospital-care-inpac/assessment-sga</url>
    <description>Assessment: SGA</description>
  </link>
  <link>
    <url>http://nutritioncareincanada.ca/sites/default/uploads/files/MAT-MITT-Tools_2017.pdf</url>
    <description>Food Monitoring Tools</description>
  </link>
  <link>
    <url>https://www.cag-acg.org/images/cddw/diet_gi_health_nutrition_in_canada_gramlich.pdf</url>
    <description>The Prevalence and Impact of Malnutrition in Canadian Hospitals</description>
  </link>
  <link>
    <url>http://www.sample-size.net/sample-size-means/</url>
    <description>Sample size calculation tool</description>
  </link>
  <link>
    <url>https://nutritioncareincanada.ca/prevention-and-awareness/healthcare-professionals-decision-makers</url>
    <description>Tackling Malnutrition Resource</description>
  </link>
  <reference>
    <citation>Allard JP, Keller H, Teterina A, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Davidson B, Lou W. Lower handgrip strength at discharge from acute care hospitals is associated with 30-day readmission: A prospective cohort study. Clin Nutr. 2016 Dec;35(6):1535-1542. doi: 10.1016/j.clnu.2016.04.008. Epub 2016 Apr 13.</citation>
    <PMID>27155939</PMID>
  </reference>
  <reference>
    <citation>Allard JP, Keller H, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Davidson B, Teterina A, Lou W. Decline in nutritional status is associated with prolonged length of stay in hospitalized patients admitted for 7 days or more: A prospective cohort study. Clin Nutr. 2016 Feb;35(1):144-152. doi: 10.1016/j.clnu.2015.01.009. Epub 2015 Jan 21.</citation>
    <PMID>25660316</PMID>
  </reference>
  <reference>
    <citation>Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011 Feb;8(2):514-27. doi: 10.3390/ijerph8020514. Epub 2011 Feb 16.</citation>
    <PMID>21556200</PMID>
  </reference>
  <reference>
    <citation>Bharadwaj S, Ginoya S, Tandon P, Gohel TD, Guirguis J, Vallabh H, Jevenn A, Hanouneh I. Malnutrition: laboratory markers vs nutritional assessment. Gastroenterol Rep (Oxf). 2016 Nov;4(4):272-280. doi: 10.1093/gastro/gow013. Epub 2016 May 11.</citation>
    <PMID>27174435</PMID>
  </reference>
  <reference>
    <citation>Curtis LJ, Valaitis R, Laur C, McNicholl T, Nasser R, Keller H. Low food intake in hospital: patient, institutional, and clinical factors. Appl Physiol Nutr Metab. 2018 Dec;43(12):1239-1246. doi: 10.1139/apnm-2018-0064. Epub 2018 May 8.</citation>
    <PMID>29738268</PMID>
  </reference>
  <reference>
    <citation>Curtis LJ, Bernier P, Jeejeebhoy K, Allard J, Duerksen D, Gramlich L, Laporte M, Keller HH. Costs of hospital malnutrition. Clin Nutr. 2017 Oct;36(5):1391-1396. doi: 10.1016/j.clnu.2016.09.009. Epub 2016 Sep 19.</citation>
    <PMID>27765524</PMID>
  </reference>
  <reference>
    <citation>Eckert KF, Cahill LE. Malnutrition in Canadian hospitals. CMAJ. 2018 Oct 9;190(40):E1207. doi: 10.1503/cmaj.180108. No abstract available.</citation>
    <PMID>30301744</PMID>
  </reference>
  <reference>
    <citation>Edwards D, Carrier J, Hopkinson J. Assistance at mealtimes in hospital settings and rehabilitation units for patients (&gt;65years) from the perspective of patients, families and healthcare professionals: A mixed methods systematic review. Int J Nurs Stud. 2017 Apr;69:100-118. doi: 10.1016/j.ijnurstu.2017.01.013. Epub 2017 Jan 30.</citation>
    <PMID>28199923</PMID>
  </reference>
  <reference>
    <citation>Flood A, Chung A, Parker H, Kearns V, O'Sullivan TA. The use of hand grip strength as a predictor of nutrition status in hospital patients. Clin Nutr. 2014 Feb;33(1):106-14. doi: 10.1016/j.clnu.2013.03.003. Epub 2013 Mar 27.</citation>
    <PMID>23615623</PMID>
  </reference>
  <reference>
    <citation>Marsik C, Kazemi-Shirazi L, Schickbauer T, Winkler S, Joukhadar C, Wagner OF, Endler G. C-reactive protein and all-cause mortality in a large hospital-based cohort. Clin Chem. 2008 Feb;54(2):343-9. doi: 10.1373/clinchem.2007.091959. Epub 2007 Dec 21.</citation>
    <PMID>18156283</PMID>
  </reference>
  <reference>
    <citation>Manning F, Harris K, Duncan R, Walton K, Bracks J, Larby L, Vari L, Jukkola K, Bell J, Chan M, Batterham M. Additional feeding assistance improves the energy and protein intakes of hospitalised elderly patients. A health services evaluation. Appetite. 2012 Oct;59(2):471-7. doi: 10.1016/j.appet.2012.06.011. Epub 2012 Jun 23.</citation>
    <PMID>22735333</PMID>
  </reference>
  <reference>
    <citation>Sandhaus S, Zalon ML, Valenti D, Dzielak E, Smego RA Jr, Arzamasova U. A volunteer-based Hospital Elder Life Program to reduce delirium. Health Care Manag (Frederick). 2010 Apr-Jun;29(2):150-6. doi: 10.1097/HCM.0b013e3181daa2a0.</citation>
    <PMID>20436332</PMID>
  </reference>
  <reference>
    <citation>Walton K, Williams P, Bracks J, Zhang Q, Pond L, Smoothy R, Tapsell L, Batterham M, Vari L. A volunteer feeding assistance program can improve dietary intakes of elderly patients--a pilot study. Appetite. 2008 Sep;51(2):244-8. doi: 10.1016/j.appet.2008.02.012. Epub 2008 Feb 17.</citation>
    <PMID>18387692</PMID>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>May 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>August 14, 2022</last_update_submitted>
  <last_update_submitted_qc>August 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Joseph Brant Hospital</investigator_affiliation>
    <investigator_full_name>Diala Chayab</investigator_full_name>
    <investigator_title>Clinical Dietitian</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The sponsor will comply with data sharing processes according to local laws and regulations. Aggregate study results will be reported on clinicaltrials.gov. Anonymized study IPD can only be shared upon request from a regulator, an ethics committee board or by a healthcare professional for future research purposes.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>IPD and any additional supporting information will become available starting 6months post-study publications for a period of 2-5 years.</ipd_time_frame>
    <ipd_access_criteria>IPD can only be shared upon request from a regulator, an ethics committee board or by a healthcare professional for future research purposes. The study sponsor and principal investigator will be responsible to review requests in accordance with local regulations and institutional policies.</ipd_access_criteria>
  </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/NCT04445883
org study id: JosephBrantH
nct id: NCT04445883
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This research study will determine the impact of the Eating Matters Program on the
      nutritional status of elderly patients at Joseph Brant Hospital. The Eating Matters Program
      at Joseph Brant Hospital is a volunteer-based feeding assistance program that aims to improve
      patients' nutritional intake by providing assistance during mealtimes. As research on the
      impact of such programs on food intake is limited in Canada, this study will explore how the
      Eating Matters Program influences protein and energy intake of patients at Joseph Brant
      Hospital. Further, this study will explore if the hypothesized increase in protein and energy
      intake with the initiation of the Eating Matters Program is correlated with a decreased risk
      of malnutrition.
We will be conducting a prospective open-label non-randomized controlled trial to evaluate
      patients' nutritional outcomes in units that have the Eating Matters Program available (Study
      Group A) vs. similar units that do not have this program (Control Group B), as this can
      provide useful data on the effectiveness of such programs in developing innovative prevention
      strategies to address hospital malnutrition.

      A total sample size of eighty participants (40 in each group) will be included in this study
      from Medical and Rehabilitation units at Joseph Brant Hospital. Study group A will include
      patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Control
      Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200.
      Baseline food intake data (including breakfast, lunch and dinner) will be gathered during a
      2-day period for both Study Group A and Control Group B. Following the collection of baseline
      data, feeding assistance will then be provided to participants in the units that have the EMP
      program available (6S100 and 6N400/500). In addition, food intake will be recorded for a
      total of 6 days for both Study Group A, and Control Group B. Outcome measures including
      C-reactive protein and weight will be measured weekly. Following, a Subjective Global
      Assessment (SGA) will be completed and Hand Grip Strength will be recorded on days 1 and 18
      as the literature shows that this is an appropriate timeframe to reassess these measures
      (Flood et al., 2014; Canadian Malnutrition Task Force, 2019). Energy and protein intake will
      then be calculated using visual estimation by completion of the My Meal Intake Tool, and the
      hospital's CBORD software. Further, to evaluate the success of the feeding assistance
      program, volunteers will distribute the feedback survey to patients, staff, family members or
      friends of participants. To prevent contamination from staff working on both sides, members
      of the research team will have a discussion with staff to explain that the study and
      potential benefits should not be discussed, as this may impact the research findings.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The investigators will be evaluating patients' nutritional outcomes in units that have the Eating Matters Program available vs. similar units that do not have this program. Therefore, there will be two groups, Study Group A and Control Group B.
primary purpose: Prevention
masking: None (Open Label)
measure: Dietary Intake
time frame: To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days).
description: Protein and Energy Intake
measure: Percent weight change
time frame: A change from baseline body weight at 1 week and 2 weeks marks (+/-2) days post the initiation of the Eating Matters Program (EMP).
description: Participants' weight will be measured.
measure: Handgrip strength
time frame: A change from baselines in handgrip measure at 1 and 2 weeks marks (+/-2 days) post the initiation of EMP.
description: Handgrip strength measured using hand dynamometers.
measure: C-Reactive Protein
time frame: A change from baselines CRP at 1 week and 2 weeks marks (+/-2 days) post the initiation of EMP.
description: C-Reactive Protein will be measured via routine lab work.
measure: Eating Matters Program Feedback
time frame: This will be measured on day 19 (+/-2 days) (total study period for each participant).
description: Perceptions of program implementation and Barriers to food intake will be evaluated via feedback forms.
measure: Length of stay
time frame: This data will be gathered on day 120 (+/-2days), upon completion of the study.
description: Unit Specific Measure
measure: Mortality rate
time frame: This data will be gathered on day 120 (+/- 2days), upon completion of the study.
description: Unit Specific Measure
measure: Re-admission rate
time frame: This data will be gathered on day 120 (+/- 2 days), upon completion of the study.
description: Unit Specific Measure
arm group label: Study Group A
arm group type: Experimental
description: Study group A will include patients from the medical unit on 6S100 in addition to the Rehab units on 6N400/500. Participants in Study Group A will be receiving mealtime assistance from volunteers via the Eating Matters Program.
arm group label: Control Group B
arm group type: No Intervention
description: Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200.
intervention type: Behavioral
intervention name: Feeding Assistance
description: Patients will be receiving assistance during mealtimes. This includes assistance by opening packages, listing/explaining the food products on the tray, providing encouragement and companionship during mealtimes and directly feed patients.
arm group label: Study Group A
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: https://www.albertahealthservices.ca/nutrition/Page16003.aspx
description: Time to Eat Toolkit. Retrieved from Alberta Health Services
url: https://nutritioncareincanada.ca/sites/default/uploads/files/INPAC-Toolkit-FINAL-Dec5-2017.pdf
description: Integrated Nutrition Pathway for Acute Care (INPAC) Implementation Toolkit
url: https://nutritioncareincanada.ca/resources-and-tools/hospital-care-inpac/assessment-sga
description: Assessment: SGA
url: http://nutritioncareincanada.ca/sites/default/uploads/files/MAT-MITT-Tools_2017.pdf
description: Food Monitoring Tools
url: https://www.cag-acg.org/images/cddw/diet_gi_health_nutrition_in_canada_gramlich.pdf
description: The Prevalence and Impact of Malnutrition in Canadian Hospitals
url: http://www.sample-size.net/sample-size-means/
description: Sample size calculation tool
url: https://nutritioncareincanada.ca/prevention-and-awareness/healthcare-professionals-decision-makers
description: Tackling Malnutrition Resource
citation: Allard JP, Keller H, Teterina A, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Davidson B, Lou W. Lower handgrip strength at discharge from acute care hospitals is associated with 30-day readmission: A prospective cohort study. Clin Nutr. 2016 Dec;35(6):1535-1542. doi: 10.1016/j.clnu.2016.04.008. Epub 2016 Apr 13.
PMID: 27155939
citation: Allard JP, Keller H, Jeejeebhoy KN, Laporte M, Duerksen DR, Gramlich L, Payette H, Bernier P, Davidson B, Teterina A, Lou W. Decline in nutritional status is associated with prolonged length of stay in hospitalized patients admitted for 7 days or more: A prospective cohort study. Clin Nutr. 2016 Feb;35(1):144-152. doi: 10.1016/j.clnu.2015.01.009. Epub 2015 Jan 21.
PMID: 25660316
citation: Barker LA, Gout BS, Crowe TC. Hospital malnutrition: prevalence, identification and impact on patients and the healthcare system. Int J Environ Res Public Health. 2011 Feb;8(2):514-27. doi: 10.3390/ijerph8020514. Epub 2011 Feb 16.
PMID: 21556200
citation: Bharadwaj S, Ginoya S, Tandon P, Gohel TD, Guirguis J, Vallabh H, Jevenn A, Hanouneh I. Malnutrition: laboratory markers vs nutritional assessment. Gastroenterol Rep (Oxf). 2016 Nov;4(4):272-280. doi: 10.1093/gastro/gow013. Epub 2016 May 11.
PMID: 27174435
citation: Curtis LJ, Valaitis R, Laur C, McNicholl T, Nasser R, Keller H. Low food intake in hospital: patient, institutional, and clinical factors. Appl Physiol Nutr Metab. 2018 Dec;43(12):1239-1246. doi: 10.1139/apnm-2018-0064. Epub 2018 May 8.
PMID: 29738268
citation: Curtis LJ, Bernier P, Jeejeebhoy K, Allard J, Duerksen D, Gramlich L, Laporte M, Keller HH. Costs of hospital malnutrition. Clin Nutr. 2017 Oct;36(5):1391-1396. doi: 10.1016/j.clnu.2016.09.009. Epub 2016 Sep 19.
PMID: 27765524
citation: Eckert KF, Cahill LE. Malnutrition in Canadian hospitals. CMAJ. 2018 Oct 9;190(40):E1207. doi: 10.1503/cmaj.180108. No abstract available.
PMID: 30301744
citation: Edwards D, Carrier J, Hopkinson J. Assistance at mealtimes in hospital settings and rehabilitation units for patients (>65years) from the perspective of patients, families and healthcare professionals: A mixed methods systematic review. Int J Nurs Stud. 2017 Apr;69:100-118. doi: 10.1016/j.ijnurstu.2017.01.013. Epub 2017 Jan 30.
PMID: 28199923
citation: Flood A, Chung A, Parker H, Kearns V, O'Sullivan TA. The use of hand grip strength as a predictor of nutrition status in hospital patients. Clin Nutr. 2014 Feb;33(1):106-14. doi: 10.1016/j.clnu.2013.03.003. Epub 2013 Mar 27.
PMID: 23615623
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responsible party type: Principal Investigator
investigator affiliation: Joseph Brant Hospital
investigator full name: Diala Chayab
investigator title: Clinical Dietitian
sharing ipd: Yes
ipd description: The sponsor will comply with data sharing processes according to local laws and regulations. Aggregate study results will be reported on clinicaltrials.gov. Anonymized study IPD can only be shared upon request from a regulator, an ethics committee board or by a healthcare professional for future research purposes.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: IPD and any additional supporting information will become available starting 6months post-study publications for a period of 2-5 years.
ipd access criteria: IPD can only be shared upon request from a regulator, an ethics committee board or by a healthcare professional for future research purposes. The study sponsor and principal investigator will be responsible to review requests in accordance with local regulations and institutional policies.