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

NCT ID: NCT06401694

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

1640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-20

Study Completion Date

2028-04-30

Brief Summary

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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

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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).

Conditions

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Diet, Healthy Food Insecurity Loneliness Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Enhanced

Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags

Group Type EXPERIMENTAL

Home-delivered meals

Intervention Type OTHER

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

Wellness check and socialization visit

Intervention Type OTHER

At-home delivery with opportunity for driver observation and interaction

Community Health Worker calls

Intervention Type BEHAVIORAL

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

Supplemental grocery bag

Intervention Type OTHER

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

Usual care

Home-delivered meals

Group Type ACTIVE_COMPARATOR

Home-delivered meals

Intervention Type OTHER

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

Wellness check and socialization visit

Intervention Type OTHER

At-home delivery with opportunity for driver observation and interaction

Interventions

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Home-delivered meals

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

Intervention Type OTHER

Wellness check and socialization visit

At-home delivery with opportunity for driver observation and interaction

Intervention Type OTHER

Community 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

Intervention Type BEHAVIORAL

Supplemental grocery bag

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Department of Health and Human Services

FED

Sponsor Role collaborator

Meals on Wheels Rhode Island (MOWRI)

UNKNOWN

Sponsor Role collaborator

University of Connecticut

OTHER

Sponsor Role lead

Responsible Party

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Caitlin Caspi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Caitlin Caspi, ScD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Kim Gans, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Connecticut

Locations

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University of Connecticut

Storrs, Connecticut, United States

Site Status

Countries

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United States

References

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Costa da Silva IL, Gans KM, Thomas KS, Gutman R, Tyler B, Ray S, Grady M, DeFelice S, Hussein M, Lusi A, Caspi CE. A study protocol for a randomized controlled trial evaluating the impact of adding community health worker coaching calls and healthy grocery bag deliveries to a Meals on Wheels home-delivered meal program for homebound older adults in Rhode Island. BMC Public Health. 2025 Oct 1;25(1):3285. doi: 10.1186/s12889-025-24080-6.

Reference Type DERIVED
PMID: 41034808 (View on PubMed)

Other Identifiers

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24-073-910

Identifier Type: -

Identifier Source: org_study_id