Food IntakeJBHNCT04445883
Evaluating the Impact of the Eating Matters Program on the Nutritional Status of Medical Rehab Patients at Joseph Brant Hospital
A study testing Feeding Assistance in people with Food Intake, run by Joseph Brant Hospital at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Food Intake
- What is being tested?
- Feeding Assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2024to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Patients 65 years and over admitted to Medicine and Rehabilitation units at Joseph Brant Hospital with an anticipated stay 10-14 days
- Patients with a Subjective Global Assessment score of B or C, and identified to require eating assistance
- Patients able to provide consent or have a Power of Attorney to do so on their behalf
Who cannot join
- Patients that are NPO status (nothing by mouth)
- Patients that require enteral or total parenteral feeding
- Palliative care patients
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Joseph Brant Hospital
Burlington, Ontario, L7S 0A2
Diala Chayab, MPH, RD, 905-632-3737 ext. 5511, dchayab@josephbranthospital.ca
About this study
Official title: Evaluating the Impact of a Volunteer Based Mealtime Assistance Program on the Nutritional Status of Patients at Joseph Brant Hospital in Ontario, Canada
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.
Read the detailed description
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.
- Conditions
- Food Intake
- Being tested
- Feeding Assistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeding AssistanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group A | Experimental | 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. Receives: Behavioral: Feeding Assistance |
| Control Group B | No intervention | Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dietary Intake
Protein and Energy Intake
Measured: To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start20 Jun 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Food IntakeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joseph Brant Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Western University
- Responsible party
- Principal investigator, Diala Chayab, Joseph Brant Hospital
- Investigators
- Latifa Ahmadi, PhD, Study chair, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04445883
- Sponsor's protocol ID
- JosephBrantH
- Acronym
- JBH
- Status last verified
- Aug 2025
- First submitted
- 15 May 2020
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 27155939Allard 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.
PubMed 25660316Barker 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.
PubMed 21556200Bharadwaj 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.
PubMed 27174435Curtis 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.
PubMed 29738268Curtis 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.
PubMed 27765524Eckert KF, Cahill LE. Malnutrition in Canadian hospitals. CMAJ. 2018 Oct 9;190(40):E1207. doi: 10.1503/cmaj.180108. No abstract available.
PubMed 30301744Edwards 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.
PubMed 28199923Flood 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.
PubMed 23615623Marsik 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.
PubMed 18156283Manning 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.
PubMed 22735333Sandhaus 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.
PubMed 20436332Walton 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.
PubMed 18387692
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of a Volunteer Based Mealtime Assistance Program on the Nutritional Status of Patients at Joseph Brant Hospital in Ontario, Canada
- ClinicalTrials.gov ID
- NCT04445883
- Acronym / sponsor ID
- JBH / JosephBrantH
- Conditions
- Food Intake
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Joseph Brant HospitalUniversity, hospital or other
- Collaborators
- Western University
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 24 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study Group A | Experimental | Behavioral: Feeding AssistanceStudy 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. |
| Control Group B | No intervention | –Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Patients 65 years and over admitted to Medicine and Rehabilitation units at Joseph Brant Hospital with an anticipated stay 10-14 days
- Patients with a Subjective Global Assessment score of B or C, and identified to require eating assistance
- Patients able to provide consent or have a Power of Attorney to do so on their behalf
Key exclusion criteria (4 listed)
- Patients that are NPO status (nothing by mouth)
- Patients that require enteral or total parenteral feeding
- Palliative care patients
- Severe cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeding AssistancePatients 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. | Behavioural | Study Group A |
Primary outcome
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).
Protein and Energy Intake
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Background: PubMed 27155939Allard 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.
- Background: PubMed 25660316Allard 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.
- Background: PubMed 21556200Barker 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.
- Background: PubMed 27174435Bharadwaj 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.
- Background: PubMed 29738268Curtis 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.
- Background: PubMed 27765524Curtis 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.
- Background: PubMed 30301744Eckert KF, Cahill LE. Malnutrition in Canadian hospitals. CMAJ. 2018 Oct 9;190(40):E1207. doi: 10.1503/cmaj.180108. No abstract available.
- Background: PubMed 28199923Edwards 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.
- Background: PubMed 23615623Flood 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.
- Background: PubMed 18156283Marsik 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.
- Background: PubMed 22735333Manning 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.
- Background: PubMed 20436332Sandhaus 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.
- Time to Eat Toolkit. Retrieved from Alberta Health ServicesLink provided by the sponsor.
- Integrated Nutrition Pathway for Acute Care (INPAC) Implementation ToolkitLink provided by the sponsor.
- Assessment: SGALink provided by the sponsor.
- Food Monitoring ToolsLink provided by the sponsor.
- Sample size calculation toolLink provided by the sponsor.
- Tackling Malnutrition ResourceLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Latifa Ahmadi, PhD study chair
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeding Assistance in people with Food Intake, run by Joseph Brant Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diala Chayab, MPH, RD (9056323737 ext. 5511, dchayab@josephbranthospital.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04445883, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.