Menu
Enrolling by invitation NCT06401694

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

No phase Interventional Diet, Healthy Food Insecurity Loneliness Quality of Life

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Home-delivered meals, Wellness check and socialization visit, Community Health Worker calls, Supplemental grocery bag.
Who it may be relevant to
Registry conditions: Diet, Healthy, Food Insecurity, Loneliness, Quality of Life. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Home-delivered meals
    Delivery of prepared meals compliant with Older Americans Act nutrition programs guidelines
  • Other Wellness check and socialization visit
    At-home delivery with opportunity for driver observation and interaction
  • Behavioral 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
  • Other Supplemental grocery bag
    Monthly delivery of a grocery bag containing a variety of nutritionally balanced foods and educational materials

Primary outcome measures

  • Diet Quality [Time frame: 12 weeks]
Secondary outcome measures (4)
  • Food Security [Time frame: 12 weeks]
  • Nutrition Security [Time frame: 12 weeks]
  • Loneliness [Time frame: 12 weeks]
  • Health-Related Quality of Life [Time frame: 12 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Connecticut — Storrs

Publications

  • 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) PMID 41034808

Identifiers

NCT: NCT06401694 · 24-073-910

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗