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Evaluating an Enhanced Home-delivered Meal Program on Older Adults' Health and Well-being

Evaluating the Impact and Sustainability of Enhanced Home-delivered Meal Program Services on Older Adults' Health and Well-being

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06401694
Enrollment
1640
Registered
2024-05-07
Start date
2024-06-20
Completion date
2028-04-30
Last updated
2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet, Healthy, Food Insecurity, Loneliness, Quality of Life

Brief summary

Meals on Wheels of Rhode Island (MOWRI), in partnership with the University of Connecticut (UConn), will implement and evaluate an enhanced version of its Home-Delivered Meals Program (HDMP). The project goal is to implement and test the effectiveness of an enhanced Home-Delivered Meals (HDM) service delivery approach. The enhanced approach includes community health worker (CHW) interactions and supplemental healthy grocery bags to address diet quality, food and nutrition security, loneliness, and health-related quality of life for older adults. MOWRI participants at the highest nutritional risk will be randomized to receive standard or enhanced services in order to test the effect of the intervention on health-related outcomes. Anticipated outcomes for individuals receiving enhanced services are improvements in measures of diet quality, food and nutrition security, loneliness, and health-related quality of life compared with those receiving standard HDM services.

Detailed description

The purpose of the research study is to understand the effectiveness of an enhanced Home-Delivered Meals Program (HDMP) on the health-quality of life for older adults. Specifically, the investigators will study the effectiveness of an enhanced HDMP service delivery approach that includes community health worker interactions and supplemental healthy grocery bags to address diet quality, food and nutrition security, loneliness, and health-related quality of life, compared to HDMP only. The research will take place among individuals receiving meals from Meals on Wheels Rhode Island (MOWRI). This is a pragmatic randomized controlled trial with the following objectives: 1) to develop a protocol for CHW engagement (assessment, intervention, and follow-up) with participants; 2) to implement the enhanced home delivered meals (HDM) intervention to MOWRI clients at the highest nutritional risk; 3) to evaluate the impact of the enhanced program on diet quality, food and nutrition security, loneliness, and HRQOL in a randomized study; 4) to evaluate program sustainability measures and implement process improvements to increase sustainability; 5) to disseminate program resources that will allow the program to replicate to other HDM programs; and 6) to share evaluation results with key community, policy, and academic partners. Up to 1640 participants who are individuals receiving meals from Meals on Wheels Rhode Island (MOWRI) and are at a high nutritional risk. The outcome measures are diet quality (primary outcome), food security, nutrition security, subjective isolation / loneliness, health-related quality of life (HRQOL).

Interventions

Delivery of prepared meals compliant with Older Americans Act nutrition programs guidelines

OTHERWellness check and socialization visit

At-home delivery with opportunity for driver observation and interaction

BEHAVIORALCommunity Health Worker calls

Calls from a certified Community Health Worker (CHW) to assess needs, identify gaps in care and resources, and then support health and resource coordination

OTHERSupplemental grocery bag

Monthly delivery of a grocery bag containing a variety of nutritionally balanced foods and educational materials

Sponsors

Department of Health and Human Services
CollaboratorFED
Meals on Wheels Rhode Island (MOWRI)
CollaboratorUNKNOWN
University of Connecticut
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults who are eligible for Title III - funded Meals on Wheels assistance * Can read and speak Spanish or English * Are nutritionally at risk as determined by the Nutrition Risk Assessment * Reside in the state of Rhode Island

Exclusion criteria

* Cognitive or physical limitations that prevent an individual from giving consent, as assessed by normal interactions by intake staff or study team * Cognitive or physical limitations that prevent an individual from participating in intervention or evaluation activities, as assessed by normal interactions intake staff or study team

Design outcomes

Primary

MeasureTime frameDescription
Diet Quality12 weeksDietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score

Secondary

MeasureTime frameDescription
Food Security12 weeksU.S. Household Food Security Survey Module: Six-Item Short Form; Minimum value (0) indicates high food security; Maximum value (6) indicates very low food security
Nutrition Security12 weeks2-item Nutrition Security Screener (NSS); participants responding (a) very hard, (b) hard, or (c) somewhat hard to the first question will be designated as nutrition insecure.
Loneliness12 weeksUniversity of California, Los Angeles 3-Item Loneliness Scale; Minimum value (3) indicates low feelings of loneliness; Maximum value (9) indicates high feelings of loneliness
Health-Related Quality of Life12 weeksThe Centers for Disease Control and Prevention's Health-Related Quality of Life 4-question core modules, called the Healthy Days Measures; The unhealthy days index is calculated by summing the number of physically and mentally unhealthy days, capped at 30 total days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026