Feeding Assistance for Eating

(JBH Trial)

Overseen By Ahmadi, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Joseph Brant Hospital

Disqualifiers: NPO status, Enteral feeding, Palliative, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 6 days

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a volunteer-based program at Joseph Brant Hospital can improve the nutrition of elderly patients by providing mealtime assistance. Researchers want to determine if this support increases patients' protein and energy intake, potentially reducing their risk of malnutrition. The trial compares one group of patients receiving feeding assistance with another group not receiving it. Patients who have been in the hospital for 10-14 days, need help with eating, and can give consent might be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to research that could enhance patient care and nutrition strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Eating Matters Program is safe for elderly patients?

Research has shown that programs where volunteers assist with feeding are generally safe and well-received by patients. Studies have found that these programs can increase patient food intake, which is beneficial. No reports have indicated problems or safety issues directly related to the feeding assistance. This suggests that volunteer assistance with meals poses no major risk to patients. The aim is to improve nutrition, and past research suggests this is a safe method to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Feeding Assistance treatment because it focuses on enhancing mealtime support through the Eating Matters Program, which is different from traditional care options that often lack personalized assistance. Unlike standard care, which might rely on limited staff support, this approach uses trained volunteers to provide direct help to patients during meals. This personalized interaction not only aims to improve nutritional intake but also offers social engagement, which can boost overall patient well-being and recovery.

What evidence suggests that the Eating Matters Program is effective for improving nutritional intake in elderly patients?

This trial will compare the effects of feeding assistance on elderly patients' nutrition. Research has shown that helping elderly patients with eating can greatly improve their nutrition. In one study, when volunteers assisted during meals, patients consumed more protein and calories. Another study found that elderly patients ate more when volunteers provided help. This support is linked to a lower risk of malnutrition by ensuring patients receive enough nutrients. Participants in Study Group A will receive mealtime assistance from volunteers through the Eating Matters Program, while Control Group B will not receive this intervention. Overall, feeding assistance programs show promise in helping elderly patients maintain better nutrition. ^{1 3 4 6 7}

Who Is on the Research Team?

Latifa Ahmadi, PhD

Principal Investigator

Western University

Are You a Good Fit for This Trial?

This trial is for patients aged 65 or older admitted to Medicine and Rehabilitation units at Joseph Brant Hospital, expected to stay for 10-14 days. They should need help with eating, have a moderate to high risk of malnutrition (SGA score B or C), and be able to consent themselves or through a Power of Attorney.

Inclusion Criteria

Patients able to provide consent or have a Power of Attorney to do so on their behalf

I am 65 or older and will be in the hospital for 10-14 days for rehab.

I need help with eating due to my nutrition assessment.

Exclusion Criteria

Patients that are NPO status (nothing by mouth)

I need tube or IV feeding.

Palliative care patients

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Baseline food intake data is gathered during a 2-day period for both Study Group A and Control Group B.

2 days

1 visit (in-person)

Treatment

Feeding assistance is provided to participants in Study Group A, and food intake is recorded for a total of 6 days.

6 days

Follow-up

Participants are monitored for changes in dietary intake, weight, handgrip strength, and C-reactive protein levels.

2 weeks

Feedback and Assessment

Feedback on the Eating Matters Program is collected, and assessments such as Subjective Global Assessment and Hand Grip Strength are conducted.

19 days

What Are the Treatments Tested in This Trial?

Interventions

• Feeding Assistance

Trial Overview The study is testing the Eating Matters Program, which uses volunteers to assist elderly patients during meals. The goal is to see if this assistance increases protein and energy intake, potentially reducing the risk of malnutrition among these patients.

How Is the Trial Designed?

Group I: Study Group A Experimental Treatment 1 Intervention

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.

Group II: Control Group B Active Control 1 Intervention

Control Group B will include participants from the Rehab Unit on 4N400 and the Medical unit on 6S200.

Feeding Assistance is already approved in Canada for the following indications:

Approved in Canada as Eating Matters Program for:

• Nutritional support for elderly patients
• Prevention of malnutrition

Who Is Running the Clinical Trial?

Joseph Brant Hospital

Lead Sponsor

Trials

4

Recruited

210+

Western University

Collaborator

Trials

31

Recruited

129,000+

Compass Group Canada

Collaborator

Trials

1

Recruited

80+

Published Research Related to This Trial

A scoping review of 35 studies highlights that individualized dietary treatments can significantly improve food intake and other positive health outcomes for hospitalized patients suffering from malnutrition.

While foodservice strategies that encourage patient choice show promise, and mealtime assistance can enhance food intake, more research is needed to effectively implement and evaluate these 'food first' approaches in acute care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary, food service, and mealtime interventions to promote food intake in acute care adult patients. Cheung, G., Pizzola, L., Keller, H.[2016]

In a study analyzing 36.4 million pounds of food distributed by the Oregon Food Bank, 66% of the food was categorized as nutritious according to MyPyramid guidelines, indicating a significant focus on improving the nutritional quality of emergency food supplies.

The distribution of MyPyramid Days revealed that while grains, meat/beans, and vegetables were well-represented, fruits and milk were less frequently distributed, highlighting areas for potential improvement in food resource development to enhance overall nutrition for recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional quality of emergency foods. Hoisington, A., Manore, MM., Raab, C.[2018]

A formalized training program for volunteers at Coler Memorial Hospital significantly improved the quality of meal assistance for residents in long-term care, enhancing their socialization and communication during meals.

The program also emphasized safety, addressing the risks associated with swallowing disorders and aspiration, ensuring that volunteers were better prepared to assist residents effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volunteer participation in feeding residents: training and supervision in a long-term care facility. Lipner, HS., Bosler, J., Giles, G.[2019]

The feeding assistance intervention significantly increased daily caloric intake and helped residents maintain or gain weight over 24 weeks, while the control group lost weight.

Providing feeding assistance required more staff time than usual care, but delivering snacks between meals was more time-efficient and could be a practical option for nursing homes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of unintentional weight loss in nursing home residents: a controlled trial of feeding assistance. Simmons, SF., Keeler, E., Zhuo, X., et al.[2022]

The FoodforCare (FfC) meal service significantly improved protein and energy intake among hospitalized patients, with mean daily protein intake increasing from 59% to 79% of requirements on day 1 and from 59% to 73% on day 4 compared to the traditional meal service.

Patient satisfaction with the FfC service was maintained or slightly improved, particularly regarding the appearance and smell of meals, indicating that enhancing meal services can positively impact dietary intake without compromising patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel in-hospital meal service improves protein and energy intake. Dijxhoorn, DN., van den Berg, MGA., Kievit, W., et al.[2019]

The FNS Patient Advocate program significantly improved post-discharge patient satisfaction ratings for various food and nutrition service attributes, with 73% of patients recalling their interaction and reporting high satisfaction (mean score of 5.8 on a 7-point scale).

Patients who had previously rated their satisfaction as 3 or lower showed marked improvements in satisfaction regarding special diet explanations, food temperature, food quality, server courtesy, and likelihood of receiving ordered foods after interacting with the Patient Advocate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timely resolution of patient concerns improves post-discharge satisfaction. Barsamian, AM., Gregoire, M., Sowa, D., et al.[2015]

The updated meal pattern requirements for the Child and Adult Care Food Program emphasize serving more whole grains, a greater variety of vegetables and fruits, and reducing added sugars and solid fats, aligning with the Dietary Guidelines for Americans.

These changes, which are the first major revision since 1968, aim to promote healthier eating habits in young children and improve the overall wellness of adult participants, supporting breastfeeding mothers and enhancing consistency with other nutrition programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Child and Adult Care Food Program: Meal Pattern Revisions Related to the Healthy, Hunger-Free Kids Act of 2010. Final rule. [2016]

The Food for Peace Act has evolved over 60 years from focusing on the quantity of food aid to emphasizing the quality of food assistance, particularly for vulnerable groups, impacting over 3 billion people in 150 countries.

Current discussions are centered on the use of fortified blended foods, especially the role of dairy ingredients, to prevent and treat malnutrition in the first 1000 days of life, with ongoing trials to gather more evidence on their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering Improved Nutrition: Dairy Ingredients in Food Aid Products. Schlossman, N.[2016]

The FoodMate® program, an 8-week nutrition education initiative, was well-received by participants and led to long-term improvements in their cooking skills, dietary habits, and overall life satisfaction over a follow-up period of up to 2 years.

Participants reported enhanced confidence in cooking and trying new foods, indicating that such programs can effectively promote healthy eating and food independence among individuals facing food insecurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of SecondBite® 's FoodMate® , a nutrition education and skill-building program aimed at reducing food insecurity. Stephens, LD., Smith, G., Olstad, DL., et al.[2021]

The report highlights significant issues in U.S. emergency food aid programs, including problems with the quantity and quality of food contributions, which may hinder meeting the nutritional needs of disaster victims.

It emphasizes the need for better integration of nutrition science in food aid formulation and suggests that non-nutritional priorities, such as agricultural market linkages, often overshadow the nutritional requirements of recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foods provided through U.S. Government Emergency Food Aid Programs: policies and customs governing their formulation, selection and distribution. Marchione, TJ.[2018]

A pilot study involving 9 elderly patients (average age 89) showed that trained volunteers significantly increased protein intake during lunch by an average of 10.1 grams when compared to weekends without volunteer assistance (p<0.05).

Volunteers not only improved dietary intake but also provided more social interaction and encouragement for patients to eat, suggesting that their presence could enhance nutritional care in hospitals, especially as the elderly population grows.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A volunteer feeding assistance program can improve dietary intakes of elderly patients--a pilot study. Walton, K., Williams, P., Bracks, J., et al.[2013]

A volunteer dietitian successfully revised the hospital diet manual in Liberia to better align with local food customs, which is crucial for improving dietary practices in the community.

The dietitian also provided valuable education to healthcare professionals on nutrition and specific dietary needs for malnourished children, particularly focusing on the evaluation of a kwashiorkor treatment formula.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volunteer experience of an American dietitian in Liberia, West Africa. Fairfull, CB.[2016]

Trained dining companions can significantly enhance the mealtime experience for hospitalized patients by providing assistance and promoting social interaction, which may help mitigate the risks of malnutrition.

These volunteers not only help patients eat safely but also serve as a communication link to nurses, ensuring that any issues are promptly reported and addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mealtime help. Sander, R.[2019]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04445883/evaluating-the-impact-of-the-eating-matters-program-on-the-nutritional-status-of-medical-rehab-patients-at-joseph-brant-hospital?state=CA&city=Burlington

Evaluating the Impact of the Eating Matters Program on the ... This research study will determine the impact of the Eating Matters Program on the nutritional status of elderly patients at Joseph Brant Hospital.

2. withpower.com withpower.com/trial/phase-5-2022-f5b42

Feeding Assistance for Eating (JBH Trial) Research shows that volunteer-based feeding assistance can improve dietary intake in elderly patients, as seen in a study where protein intake increased when ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723014185

Evaluation of a pilot volunteer feeding assistance program: ... Results. Eight patients (83±4.5 years) participated in the study. When volunteers were present at lunch, the average macronutrient and energy intakes increased, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3813467/

Use of Volunteers for Mealtime Assistance to Hospitalized ... This report demonstrates the feasibility of recruiting volunteers and patients for the SPOONS program and helps clarify time and cost savings associated with ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/8/8/e022285

Can trained volunteers improve the mealtime care of older ... A pilot study showed trained volunteers could safely improve mealtime care. This study evaluates the wider implementation of a mealtime assistance programme.

6. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723000623

The impact of trained volunteer mealtime assistants on ... No differences in dietary intake were found between the wards in the observational or intervention years, or in a pre-post-test comparison of patients on the ...

7. researchgate.net researchgate.net/publication/272074754_Evaluation_of_a_pilot_volunteer_feeding_assistance_program_Influences_on_the_dietary_intakes_of_elderly_hospitalised_patients_and_lessons_learnt

Evaluation of a pilot volunteer feeding assistance program Volunteer involvement in some reviewed studies showed improvement to patient outcomes such as an increase in nutritional intake. 5,15,28, 31, 32,35,36 Similar ...