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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06401694
• Other study ID #: 24-073-910
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: April 30, 2028

Study information

• Verified date: May 2024
• Source: University of Connecticut
• Contact: Brie Tyler, MPH
• Phone: 860-786-2477
• Email: brie.tyler[@]uconn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1640
• Est. completion date: April 30, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Food Insecurity
• Loneliness
• Quality of Life

Intervention

Other:
• Home-delivered meals
Delivery of prepared meals compliant with Older Americans Act nutrition programs guidelines
• 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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of Connecticut	Department of Health and Human Services (DHHS) Administration for Community Living (ACL), Meals on Wheels Rhode Island (MOWRI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diet Quality	Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score	12 weeks
Secondary	Food Security	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	12 weeks
Secondary	Nutrition Security	Gretchen Swanson Center for Nutrition: Sub-scales for Nutrition Security, Healthfulness Choice, and Dietary Choice; For each sub-scale, minimum value (0) indicates low nutrition security; Maximum value (4) indicates high nutrition security.	12 weeks
Secondary	Loneliness	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	12 weeks
Secondary	Health-Related Quality of Life	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.	12 weeks