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

Not Applicable

• Conditions: Loneliness; Quality of Life; Diet, Healthy; Food Insecurity
• Interventions: Other: Home-delivered meals; Other: Wellness check and socialization visit; Behavioral: Community Health Worker calls; Other: Supplemental grocery bag

• Registration Number: NCT06401694
• Lead Sponsor: University of Connecticut

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.

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 Timeline

• Study First Submitted: 2024-05-02
• Study First Submitted QC: 2024-05-02
• Study First Posted: 2024-05-07
• Study Start: 2024-06-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26
• Primary Completion: 2027-09-30
• Study Completion: 2028-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1640

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced	Home-delivered meals	Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags
Usual care	Home-delivered meals	Home-delivered meals
Enhanced	Supplemental grocery bag	Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags
Usual care	Wellness check and socialization visit	Home-delivered meals
Enhanced	Wellness check and socialization visit	Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags
Enhanced	Community Health Worker calls	Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags

Primary Outcome Measures

Name	Time	Method
Diet Quality	12 weeks	Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score

Secondary Outcome Measures

Name	Time	Method
Food Security	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
Nutrition Security	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.
Loneliness	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
Health-Related Quality of Life	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.

Trial Locations

Locations (1)

University of Connecticut; 🇺🇸 Storrs, Connecticut, United States