NCT06401694

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,640

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Jun 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jun 2024Apr 2028

First Submitted

Initial submission to the registry

May 2, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 20, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

3.3 years

First QC Date

May 2, 2024

Last Update Submit

December 15, 2025

Conditions

Diet, HealthyFood InsecurityLonelinessQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Diet Quality

    Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score

    12 weeks

Secondary Outcomes (4)

  • Food Security

    12 weeks

  • Nutrition Security

    12 weeks

  • Loneliness

    12 weeks

  • Health-Related Quality of Life

    12 weeks

Study Arms (2)

Enhanced

EXPERIMENTAL

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

Other: Home-delivered mealsOther: Wellness check and socialization visitBehavioral: Community Health Worker callsOther: Supplemental grocery bag

Usual care

ACTIVE COMPARATOR

Home-delivered meals

Other: Home-delivered mealsOther: Wellness check and socialization visit

Interventions

Home-delivered mealsOTHER

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

EnhancedUsual care
Wellness check and socialization visitOTHER

At-home delivery with opportunity for driver observation and interaction

EnhancedUsual care
Community Health Worker callsBEHAVIORAL

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

Enhanced
Supplemental grocery bagOTHER

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

Enhanced

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

Related Publications (1)

  • 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.

    PMID: 41034808DERIVED

Study Officials

  • Caitlin Caspi, ScD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

  • Kim Gans, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 7, 2024

Study Start

June 20, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)