2300 Participants Needed

Meal Delivery Services for Healthy Seniors

Recruiting at 11 trial locations
TS
KB
Overseen ByKimberly Bernard, PhD
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Brown University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.678910

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.411121314

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

KS

Kali S. Thomas, PhD

Principal Investigator

Johns Hopkins University School of Nursing

KP

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Frozen, Drop-shipped MealsExperimental Treatment1 Intervention
Ten frozen meals that are mailed to participants every two weeks.
Group II: Daily home delivered mealsActive Control2 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

Find a Clinic Near You

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.
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.
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.
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]

References

Effective elements of home-delivered meal services to improve energy and protein intake: A systematic review. [2020]
Does Participation in Home-Delivered Meals Programs Improve Outcomes for Older Adults? Results of a Systematic Review. [2022]
Hospital admissions in poorly nourished, compared with well-nourished, older South Australians receiving 'Meals on Wheels': findings from a pilot study. [2014]
The Nutritional Issue of Older People Receiving Home-Delivered Meals: A Systematic Review. [2021]
[A novel in-hospital meal service improves protein and energy intake]. [2018]
Meals on Wheels: Who's referring and what's on the menu? [2020]
The trace element and macronutrient content of meals-on-wheels. [2007]
Are congregate meals meeting clients' needs for "heart healthy" menus? [2019]
Meals served in Danish nursing homes and to Meals-on-Wheels clients may not offer nutritionally adequate choices. [2010]
10.United Statespubmed.ncbi.nlm.nih.gov
Commercial frozen meals: a cost-effective alternative for home-delivery in feeding programs for the elderly? [2007]
The impact of home-delivered meal services on the nutritional intake of community living older adults: a systematic literature review. [2021]
12.United Statespubmed.ncbi.nlm.nih.gov
Leveraging Home-Delivered Meal Programs to Address Unmet Needs for At-Risk Older Adults: Preliminary Data. [2020]
Home-Delivered Meals: Characterization of Food Intake in Elderly Beneficiaries. [2021]
14.United Statespubmed.ncbi.nlm.nih.gov
Home-delivered meal programs for homebound people with HIV/AIDS. [2013]
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