Evaluating the Impact of the Eating Matters Program on the Nutritional Status of Medical Rehab Patients at Joseph Brant Hospital (JBH)

August 26, 2025 updated by: Diala Chayab, Joseph Brant Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Ahmadi, PhD
  • Phone Number: 28068 519-432-8353
  • Email: lahmadi@uwo.ca

Study Locations

  • Canada
    • Ontario
      • Burlington, Ontario, Canada, L7S 0A2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients that are NPO status (nothing by mouth)
  • Patients that require enteral or total parenteral feeding
  • Palliative care patients
  • Severe cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Group A
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.
Behavioral: Feeding Assistance
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.
No Intervention: Control Group B
Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
To assess a change from baseline to energy and protein intake post program initiation at the one and two week mark (+/-2days).

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
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
Time Frame: A change from baselines in handgrip measure at 1 and 2 weeks marks (+/-2 days) post the initiation of EMP.
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
Time Frame: A change from baselines CRP at 1 week and 2 weeks marks (+/-2 days) post the initiation of EMP.
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
Time Frame: This will be measured on day 19 (+/-2 days) (total study period for each participant).
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
Time Frame: This data will be gathered on day 120 (+/-2days), upon completion of the study.
Unit Specific Measure
This data will be gathered on day 120 (+/-2days), upon completion of the study.
Mortality rate
Time Frame: This data will be gathered on day 120 (+/- 2days), upon completion of the study.
Unit Specific Measure
This data will be gathered on day 120 (+/- 2days), upon completion of the study.
Re-admission rate
Time Frame: This data will be gathered on day 120 (+/- 2 days), upon completion of the study.
Unit Specific Measure
This data will be gathered on day 120 (+/- 2 days), upon completion of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Joseph Brant Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Western University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Latifa Ahmadi, PhD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 24, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JosephBrantH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan 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 Sharing Time Frame

IPD and any additional supporting information will become available starting 6months post-study publications for a period of 2-5 years.

IPD Sharing 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 Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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