Clinical trial NCT06401694: Evaluating an Enhanced Home-delivered Meal Program on Older Adults' Health and Well-being
Official title: Evaluating the Impact and Sustainability of Enhanced Home-delivered Meal Program Services on Older Adults' Health and Well-being
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diet, Healthy
Food Insecurity
Loneliness
Quality of Life
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
name: Meals on Wheels Rhode Island (MOWRI)
First posted: 2024-05-07
Enrollment: 1640
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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

Primary outcomes:
measure: Diet Quality
timeFrame: 12 weeks
Secondary outcomes:
measure: Food Security
timeFrame: 12 weeks
measure: Nutrition Security
timeFrame: 12 weeks
measure: Loneliness
timeFrame: 12 weeks
measure: Health-Related Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Caitlin Caspi, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Connecticut
name: Kim Gans, PhD
role: PRINCIPAL_INVESTIGATOR
References: