Diet, HealthyNCT06401694
Evaluating an Enhanced Home-delivered Meal Program on Older Adults' Health and Well-being
A study testing Home-delivered meals, Wellness check and socialization visit and Community Health Worker calls in people with Diet, Healthy and Food Insecurity, run by University of Connecticut at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diet, Healthy, Food Insecurity, Loneliness
- What is being tested?
- Home-delivered meals, Wellness check and socialization visit and Community Health Worker calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,640 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2024to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Connecticut
Storrs, Connecticut, 06269
About this study
Official title: Evaluating the Impact and Sustainability of Enhanced Home-delivered Meal Program Services 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.
Read the 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).
- Conditions
- Diet, Healthy, Food Insecurity, Loneliness, Quality of Life
- Being tested
- Home-delivered meals, Wellness check and socialization visit, Community Health Worker calls, Supplemental grocery bag
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-delivered mealsOther
Delivery of prepared meals compliant with Older Americans Act nutrition programs guidelines
Wellness check and socialization visitOther
At-home delivery with opportunity for driver observation and interaction
Community Health Worker callsBehavioural
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 bagOther
Monthly delivery of a grocery bag containing a variety of nutritionally balanced foods and educational materials
| Study group | Role | What they receive |
|---|---|---|
| Enhanced | Experimental | Home-delivered meals plus Community Health Worker Calls and supplemental grocery bags Receives: Other: Home-delivered meals; Other: Wellness check and socialization visit; Behavioral: Community Health Worker calls; Other: Supplemental grocery bag |
| Usual care | Active comparator | Home-delivered meals Receives: Other: Home-delivered meals; Other: Wellness check and socialization visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet Quality
Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score
Measured: 12 weeks
Secondary outcomes (4)
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
Measured: 12 weeks
Nutrition Security
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.
Measured: 12 weeks
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
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start20 Jun 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,640 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Connecticut
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services, Meals on Wheels Rhode Island (MOWRI)
- Responsible party
- Principal investigator, Caitlin Caspi, University of Connecticut
- Investigators
- Caitlin Caspi, ScD, Principal investigator, University of ConnecticutKim Gans, PhD, Principal investigator, University of Connecticut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401694
- Sponsor's protocol ID
- 24-073-910
- Status last verified
- Dec 2025
- First submitted
- 2 May 2024
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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):3285. doi: 10.1186/s12889-025-24080-6.
PubMed 41034808
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact and Sustainability of Enhanced Home-delivered Meal Program Services on Older Adults' Health and Well-being
- ClinicalTrials.gov ID
- NCT06401694
- Acronym / sponsor ID
- 24-073-910
- Conditions
- Diet, Healthy, Food Insecurity, Loneliness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,640 participants (estimated)
- Lead sponsor
- University of ConnecticutUniversity, hospital or other
- Collaborators
- Department of Health and Human Services, Meals on Wheels Rhode Island (MOWRI)
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced | Experimental | Other: Home-delivered meals, Other: Wellness check and socialization visit, Behavioral: Community Health Worker calls, Other: Supplemental grocery bagHome-delivered meals plus Community Health Worker Calls and supplemental grocery bags |
| Usual care | Active comparator | Other: Home-delivered meals, Other: Wellness check and socialization visitHome-delivered meals |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-delivered mealsDelivery of prepared meals compliant with Older Americans Act nutrition programs guidelines | Other | Enhanced, Usual care |
| Wellness check and socialization visitAt-home delivery with opportunity for driver observation and interaction | Other | Enhanced, Usual care |
| Community Health Worker callsCalls from a certified Community Health Worker (CHW) to assess needs, identify gaps in care and resources, and then support health and resource coordination | Behavioural | Enhanced |
| Supplemental grocery bagMonthly delivery of a grocery bag containing a variety of nutritionally balanced foods and educational materials | Other | Enhanced |
Primary outcome
Diet Quality
Time frame: 12 weeks
Dietary Screening Tool (DST); Minimum value (0) indicates lowest possible score; Maximum value (100) indicates highest possible score
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Derived from this study: PubMed 41034808Costa 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):3285. doi: 10.1186/s12889-025-24080-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin Caspi, ScD principal investigator
University of Connecticut
Kim Gans, PhD principal investigator
University of Connecticut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-delivered meals, Wellness check and socialization visit and Community Health Worker calls in people with Diet, Healthy and Food Insecurity, run by University of Connecticut at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diet Quality (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401694, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.