Meal Delivery Services for Healthy Seniors

Recruiting at 11 trial locations

Overseen By Kimberly Bernard, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Brown University

Disqualifiers: Non-English/Spanish, Renal disease, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

2300 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 'Meal Delivery Services for Healthy Seniors'?

Research shows that home-delivered meal services, like Meals on Wheels, can improve energy and protein intake and increase satisfaction among older adults. These services help maintain independence and improve nutritional status, especially when they include additional snacks or enriched foods. ^{1 2 3 4 5}

Is it safe for seniors to participate in meal delivery services like Meals on Wheels?

Meal delivery services for seniors, such as Meals on Wheels, generally provide adequate nutrition, but some meals may have high sodium levels and may not always meet specific dietary needs like low fat or low cholesterol. It's important for participants to consider their personal dietary restrictions and consult with healthcare providers if needed. ^{6 7 8 9 10}

How is the treatment of prepared meals unique for healthy seniors?

Prepared meals for healthy seniors are unique because they provide convenient, home-delivered nutrition that can help maintain a balanced diet, especially for those who may have difficulty preparing meals themselves. Unlike other treatments, this approach focuses on improving nutritional intake and supporting independent living by delivering meals directly to the home. ^{4 11 12 13 14}

What is the purpose of this trial?

This study will randomly assign 2,300 older adults on waiting lists at fourteen Meals on Wheels programs in Florida, Illinois, Maryland, Tennessee, Texas, North Carolina, South Carolina, and California into two groups who will receive: (a) daily delivery of meals, five days a week or (b) a shipment of 10 frozen meals, every two weeks. Researchers will examine participants' Medicare claims to understand if differences in healthcare utilization occur between the two groups within six months after they start receiving meals. Researchers will also ask participants questions prior to receiving meals, and again at three months, to understand how meals impact their ability to obtain food, their feelings of loneliness, and their overall quality of life. The primary study outcome will be the ratio of days spent in institutional settings (i.e., hospital, nursing home) in the six months after participants begin receiving meals. The secondary outcomes include the ratio of days spent in institutional settings in the three months after participants begin receiving meals, food insecurity, subjective isolation/loneliness, and health-related quality of life. The team will also examine differences in dietary intake between the two groups as an exploratory outcome.

Research Team

Kali S. Thomas, PhD

Principal Investigator

Johns Hopkins University School of Nursing

Kimberly P. Bernard, PhD

Principal Investigator

Brown University School of Public Health

Eligibility Criteria

This trial is for older adults aged 66 or above who are on waiting lists at certain Meals on Wheels programs and live within the program's daily service area. Participants must be able to take part in phone surveys/interviews and speak English or Spanish.

Inclusion Criteria

On program waiting list

I am 66 years old or older.

Must reside in program's daily service area

Exclusion Criteria

Unable to participate in a phone survey/interview (e.g., difficulty hearing, lack of comprehension of study purpose, does not have working phone)

I have advanced kidney disease and follow a special kidney diet.

English or Spanish is not my first language.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either daily home-delivered meals with wellness checks and socialization or frozen meals mailed every two weeks

6 months

Ongoing meal delivery with wellness checks for daily delivery group

Follow-up

Participants are monitored for healthcare utilization, food insecurity, loneliness, and quality of life

3 months

Treatment Details

Interventions

• Prepared Meals
• Wellness Check and Socialization

Trial Overview The study compares two meal delivery methods: daily delivery of meals five days a week versus bi-weekly shipment of frozen meals. It aims to see if there's a difference in healthcare use, feelings of loneliness, food security, and quality of life between these groups.

Participant Groups

Group I: Frozen, Drop-shipped Meals Experimental Treatment 1 Intervention

Ten frozen meals that are mailed to participants every two weeks.

Group II: Daily home delivered meals Active Control 2 Interventions

A lunch-time meal delivered to participants' homes five days per week with wellness check and socialization.

Prepared Meals is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Home-Delivered Meals for:

• Nutritional support for older adults
• Food insecurity prevention
• Malnutrition prevention

Approved in Canada as Meals on Wheels for:

• Nutritional support for seniors
• Social isolation prevention

Approved in European Union as Prepared Meal Services for:

• Nutritional support for elderly
• Health-related quality of life improvement

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Meals on Wheels America

Collaborator

Trials

2

Recruited

2,500+

Meals on Wheels America

Collaborator

Trials

2

Recruited

2,500+

Findings from Research

Home-delivered meal services, like Meals on Wheels, can enhance energy and protein intake for older adults by including protein-enriched options and providing full-day meal plans, according to a systematic review of 19 studies.

Despite the positive outcomes, none of the studies were rated as high quality, highlighting the need for further research to optimize these meal services for better nutritional care at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. IJmker-Hemink, VE., Dijxhoorn, DN., Briseno Ozumbilla, CM., et al.[2020]

Home-delivered meal programs can significantly support the health and independence of older adults, particularly those facing food insecurity or transitioning from care settings to home, as highlighted by a systematic review of 80 studies.

Most studies reviewed were descriptive and lacked rigorous outcomes, indicating a need for more comprehensive research to understand barriers to access and to optimize meal delivery models for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Participation in Home-Delivered Meals Programs Improve Outcomes for Older Adults? Results of a Systematic Review. Campbell, AD., Godfryd, A., Buys, DR., et al.[2022]

In a study of 250 older South Australians, those receiving 'Meals on Wheels' (MOW) did not show significant differences in health outcomes or hospital admissions compared to those not receiving MOW, despite both groups being poorly nourished.

While MOW did not prevent weight loss or hospital admissions, it may still have a role in reducing hospital stays for nutritionally vulnerable older adults, suggesting further investigation is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital admissions in poorly nourished, compared with well-nourished, older South Australians receiving 'Meals on Wheels': findings from a pilot study. Luscombe-Marsh, N., Chapman, I., Visvanathan, R.[2014]

Older adults receiving home-delivered meals are at a high risk of undernutrition, highlighting a significant nutritional concern for this population.

Improving home-delivered meal services, such as by adding dietetic counseling or enriched food options, can enhance nutritional status and intake, but even these improvements may not fully meet the recommended nutritional needs of all recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Nutritional Issue of Older People Receiving Home-Delivered Meals: A Systematic Review. Fleury, S., Tronchon, P., Rota, J., et al.[2021]

The novel FoodforCare meal service significantly improved protein and energy intake among patients compared to the traditional meal service, with notable increases in intake on both the first and fourth days of full oral intake.

Patient satisfaction with the meal service remained stable, but the FoodforCare group reported better satisfaction regarding the appearance and smell of the meals, indicating a positive reception of the new service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. Dijxhoorn, DN., van den Berg, MGA., Drenth, JPH., et al.[2018]

There was a decline in the number of referrals to the Meals on Wheels service from hospitals between 2008 and 2012, indicating a potential gap in access for older adults.

The most popular meal choice, the 'main meal' alone, failed to meet the energy and protein requirements for men and did not fully satisfy the nutritional needs for women unless combined with soup and dessert, highlighting the need for improved meal options that align with nutritional guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meals on Wheels: Who's referring and what's on the menu? Charlton, KE., Tjong, M., North, J., et al.[2020]

The analysis of 35 meals-on-wheels for seven housebound elderly individuals showed that these meals generally provided adequate energy, protein, calcium, phosphorus, potassium, and iron, meeting essential nutrient needs.

However, the meals were found to be low in several trace elements like magnesium, manganese, copper, chromium, and zinc, and had relatively high sodium levels, indicating a need for improved nutrient balance in meal planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The trace element and macronutrient content of meals-on-wheels. Bunker, VW., Stansfield, MF., Clayton, BE.[2007]

A dietary analysis of meals from a large congregate feeding program revealed that most meals exceeded recommended guidelines for calories, cholesterol, and fat content, which may impact the health of older adults.

Among 438 surveyed clients aged 60 and older, 30% reported following special diets, primarily low sodium and low fat/low cholesterol, and those with dietary restrictions consumed fewer meals per week compared to those without restrictions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are congregate meals meeting clients' needs for "heart healthy" menus? Moran, MB., Reed, E.[2019]

A study analyzing 389 meal samples from 10 kitchens found that the nutritional content of meals served to older adults in Danish nursing homes and through Meals-on-Wheels often did not meet recommended dietary guidelines.

The meals, including standard, energy-dense, and texture-modified options, frequently lacked adequate energy and protein, highlighting a significant issue of undernutrition among this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meals served in Danish nursing homes and to Meals-on-Wheels clients may not offer nutritionally adequate choices. Beck, AM., Hansen, KS.[2010]

The study compared the costs of eight commercial frozen meals and eight congregate-site frozen meals, finding that only half of the congregate-site meals were cheaper, with an average cost per ounce just one cent less than commercial meals.

Preference data from elderly participants showed a significantly higher liking for four of the eight commercial meals, which were also less expensive per ounce, suggesting that commercial meals may be a more cost-effective option for nutrition programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commercial frozen meals: a cost-effective alternative for home-delivery in feeding programs for the elderly? Tak, J., Gregoire, MB., Morcos, SH.[2007]

Home-delivered meal services significantly improve the dietary intake of energy, protein, and certain micronutrients in community-living older adults, based on a systematic review of 13 studies.

Increased energy and protein intake from these meal services helps reduce the risk of malnutrition and supports overall health, recovery from illness, and bone health due to higher calcium intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of home-delivered meal services on the nutritional intake of community living older adults: a systematic literature review. Walton, K., do Rosario, VA., Pettingill, H., et al.[2021]

A pilot study involving home-delivered meal programs showed that training meal delivery personnel to use a mobile app for reporting client health changes led to 429 alerts for 189 clients over 12 months, indicating a proactive approach to monitoring vulnerable older adults.

The majority of alerts were related to health changes, and follow-ups resulted in 132 referrals for services, suggesting that this method can effectively identify and address unmet needs, potentially improving the quality of life for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging Home-Delivered Meal Programs to Address Unmet Needs for At-Risk Older Adults: Preliminary Data. Morris, AM., Engelberg, JK., Schmitthenner, B., et al.[2020]

In a study of 64 elderly individuals (ages 70-97) using a home delivery meal service, 70-80% did not meet the recommended nutritional intake for energy and macronutrients, highlighting a significant gap in their dietary needs.

Participants who received two to three meals per day had better energy and protein intakes compared to those receiving only one meal, suggesting that increasing meal frequency could help improve nutritional status among the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Delivered Meals: Characterization of Food Intake in Elderly Beneficiaries. Fleury, S., Van Wymelbeke-Delannoy, V., Lesourd, B., et al.[2021]

Seventeen community-based, home-delivered meal programs have been established in major cities over the past decade to address the specialized nutritional needs of homebound individuals living with HIV/AIDS.

These programs not only provide meals but also include nutrition counseling and regular evaluations, highlighting the importance of clinical dietitians and public health nutritionists in referring clients to these essential services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-delivered meal programs for homebound people with HIV/AIDS. Kraak, VI.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Does Participation in Home-Delivered Meals Programs Improve Outcomes for Older Adults? Results of a Systematic Review. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Hospital admissions in poorly nourished, compared with well-nourished, older South Australians receiving 'Meals on Wheels': findings from a pilot study. [2014]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The Nutritional Issue of Older People Receiving Home-Delivered Meals: A Systematic Review. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[A novel in-hospital meal service improves protein and energy intake]. [2018]

6. Australia pubmed.ncbi.nlm.nih.gov

Meals on Wheels: Who's referring and what's on the menu? [2020]

7. England pubmed.ncbi.nlm.nih.gov

The trace element and macronutrient content of meals-on-wheels. [2007]

8. United States pubmed.ncbi.nlm.nih.gov

Are congregate meals meeting clients' needs for "heart healthy" menus? [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Meals served in Danish nursing homes and to Meals-on-Wheels clients may not offer nutritionally adequate choices. [2010]

10. United States pubmed.ncbi.nlm.nih.gov

Commercial frozen meals: a cost-effective alternative for home-delivery in feeding programs for the elderly? [2007]

11. England pubmed.ncbi.nlm.nih.gov

The impact of home-delivered meal services on the nutritional intake of community living older adults: a systematic literature review. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Leveraging Home-Delivered Meal Programs to Address Unmet Needs for At-Risk Older Adults: Preliminary Data. [2020]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Home-Delivered Meals: Characterization of Food Intake in Elderly Beneficiaries. [2021]

14. United States pubmed.ncbi.nlm.nih.gov

Home-delivered meal programs for homebound people with HIV/AIDS. [2013]