Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Western University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control Group B | No Intervention | Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feeding Assistance | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Intake | Protein and Energy Intake | To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percent weight change | Participants' weight will be measured. | A change from baseline body weight at 1 week and 2 weeks marks (+/-2) days post the initiation of the Eating Matters Program (EMP). |
| Handgrip strength |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Diala Chayab, MPH, RD | Contact | 9056323737 | 5511 | dchayab@josephbranthospital.ca |
| Ahmadi, PhD | Contact | 519-432-8353 | 28068 | lahmadi@uwo.ca |
| Name | Affiliation | Role |
|---|---|---|
| Latifa Ahmadi, PhD | Western University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph Brant Hospital | Recruiting | Burlington | Ontario | L7S 0A2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27155939 | Background | 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. | |
| 25660316 |
| Label | URL |
|---|---|
| Time to Eat Toolkit. Retrieved from Alberta Health Services | View source |
Not provided
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 and any additional supporting information will become available starting 6months post-study publications for a period of 2-5 years.
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.
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 20, 2026 | |
| Reset | Jun 16, 2026 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 20, 2026 | Jun 16, 2026 |
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.
Not provided
Not provided
Not provided
Not provided
Handgrip strength measured using hand dynamometers.
| A change from baselines in handgrip measure at 1 and 2 weeks marks (+/-2 days) post the initiation of EMP. |
| C-Reactive Protein | C-Reactive Protein will be measured via routine lab work. | A change from baselines CRP at 1 week and 2 weeks marks (+/-2 days) post the initiation of EMP. |
| Eating Matters Program Feedback | Perceptions of program implementation and Barriers to food intake will be evaluated via feedback forms. | This will be measured on day 19 (+/-2 days) (total study period for each participant). |
| Length of stay | Unit Specific Measure | This data will be gathered on day 120 (+/-2days), upon completion of the study. |
| Mortality rate | Unit Specific Measure | This data will be gathered on day 120 (+/- 2days), upon completion of the study. |
| Re-admission rate | Unit Specific Measure | This data will be gathered on day 120 (+/- 2 days), upon completion of the study. |
| 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. |
| 21556200 | Background | 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. |
| 27174435 | Background | 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. |
| 29738268 | Background | 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. |
| 27765524 | Background | 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. |
| 30301744 | Background | Eckert KF, Cahill LE. Malnutrition in Canadian hospitals. CMAJ. 2018 Oct 9;190(40):E1207. doi: 10.1503/cmaj.180108. No abstract available. |
| 28199923 | Background | 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. |
| 23615623 | Background | 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. |
| 18156283 | Background | 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. |
| 22735333 | Background | 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. |
| 20436332 | Background | 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. |
| 18387692 | Background | 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. |
| Integrated Nutrition Pathway for Acute Care (INPAC) Implementation Toolkit | View source |
| Assessment: SGA | View source |
| Food Monitoring Tools | View source |
| Sample size calculation tool | View source |
| Tackling Malnutrition Resource | View source |