- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06401694
Evaluating an Enhanced Home-delivered Meal Program on Older Adults' Health and Well-being
December 15, 2025 updated by: Caitlin Caspi, University of Connecticut
Evaluating the Impact and Sustainability of Enhanced Home-delivered Meal Program Services on Older Adults' Health and Well-being
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.
Study Overview
Status
Enrolling by invitation
Conditions
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).
Study Type
Interventional
Enrollment (Estimated)
1640
Phase
- 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 Locations
-
-
Connecticut
-
Storrs, Connecticut, United States, 06269
- University of Connecticut
-
-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
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: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enhanced
Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags
|
Delivery of prepared meals compliant with Older Americans Act nutrition programs guidelines
At-home delivery with opportunity for driver observation and interaction
Calls from a certified Community Health Worker (CHW) to assess needs, identify gaps in care and resources, and then support health and resource coordination
Monthly delivery of a grocery bag containing a variety of nutritionally balanced foods and educational materials
|
|
Active Comparator: Usual care
Home-delivered meals
|
Delivery of prepared meals compliant with Older Americans Act nutrition programs guidelines
At-home delivery with opportunity for driver observation and interaction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diet Quality
Time Frame: 12 weeks
|
Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Food Security
Time Frame: 12 weeks
|
U.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
|
12 weeks
|
|
Loneliness
Time Frame: 12 weeks
|
University of California, Los Angeles 3-Item Loneliness Scale; Minimum value (3) indicates low feelings of loneliness; Maximum value (9) indicates high feelings of loneliness
|
12 weeks
|
|
Health-Related Quality of Life
Time Frame: 12 weeks
|
The 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.
|
12 weeks
|
|
Nutrition Security
Time Frame: 12 weeks
|
2-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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Caitlin Caspi, ScD, University of Connecticut
- Principal Investigator: Kim Gans, PhD, University of Connecticut
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.
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)
June 20, 2024
Primary Completion (Estimated)
September 30, 2027
Study Completion (Estimated)
April 30, 2028
Study Registration Dates
First Submitted
May 2, 2024
First Submitted That Met QC Criteria
May 2, 2024
First Posted (Actual)
May 7, 2024
Study Record Updates
Last Update Posted (Actual)
December 16, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 24-073-910
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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