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Enrolling by Invitation

NCT Number: NCT06401694

Evaluating an Enhanced Home-delivered Meal Program 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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Connecticut

Storrs, Connecticut, 06269, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-delivered meals

Other

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

Wellness check and socialization visit

Other

At-home delivery with opportunity for driver observation and interaction

Community Health Worker calls

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

Other

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

Primary outcomes

  1. Diet Quality

    Time frame: 12 weeks

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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Department of Health and Human Services
  • Meals on Wheels Rhode Island (MOWRI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
May 7, 2024
Registry last updated
Dec 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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