ElderFRESHNCT07896408
Foodservice Robots Engaging Senior Health
A study testing Robot-Assisted Last-Mile Food Delivery (RALMFD) in people with Elder, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to find better ways to help older adults living in rural areas get access to fresh fruits and vegetables. The researchers want to find out whether delivering fresh produce to the participant's home using a delivery robot is a workable and acceptable way to help them eat more fruits and… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elder
- What is being tested?
- Robot-Assisted Last-Mile Food Delivery (RALMFD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2029to May 2031
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Currently living in Portage County, WI
- Age 65 or above
- Able to communicate in English
- Willing to participate in a focus group
Who cannot join
- Severe swallowing difficulties that require texture-modified diets
- Only a short-term stay in Portage (<12 weeks)
- Plan to travel for more than 4 weeks
- Allergy to any fruits or vegetables
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wan-chin Kuo, PhD, RN contact
United States1 site
University of Wisconsin - Madison
Madison, Wisconsin, 53715
Zhenhua Zhu, PhD
About this study
Official title: Enhancing Healthy Food Access for Seniors in Food Deserts Through Robot-Assisted Delivery Systems
The purpose of this study is to find better ways to help older adults living in rural areas get access to fresh fruits and vegetables. The researchers want to find out whether delivering fresh produce to the participant's home using a delivery robot is a workable and acceptable way to help them eat more fruits and vegetables.
Participants will:
- Receive fresh fruits and vegetables delivered to their home twice a week by the Robot-Assisted Last-Mile Food Delivery (RALMFD) system; and,
- complete a journal and questionnaires.
- Conditions
- Elder
- Being tested
- Robot-Assisted Last-Mile Food Delivery (RALMFD)
- Keywords
- rural community
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Assisted Last-Mile Food Delivery (RALMFD)Device
RALMFD will deliver fresh fruits and vegetables twice per week for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Elders living in rural communities | Experimental | Elders will receive food delivery by RALMFD Receives: Device: Robot-Assisted Last-Mile Food Delivery (RALMFD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of RALMFD
Acceptability will be discussed during a focus group after the 10-week meal delivery period.
Measured: 10 weeks
Feasibility of RALMFD
Feasibility will be measured by delivery completion rate
Measured: 10 weeks
Usability of RALMFD
Usability will be measured using Brooke's System Usability Scale (SUS). Respondents rate 10 standard statements on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). The weighted composite score ranges from 1-100, with a higher score indicating better usability.
Measured: 10 weeks
Secondary outcomes (5)
Change in Food Habit Questionnaire (FHQ) score
FHQ consists of 22 items asking about fat-related eating habits (e.g., excluding, modifying, substituting, and replacing) over the past month. It is scored using a 4-point Likert scale, where 1 = usually and 4 = rarely or never. The composite score is divided by 22. Hence, the score ranges from 1 to 4, with lower scores indicating healthier eating habits.
Measured: Baseline to 10 weeks
Change in NCI Fruit and Vegetable Screener score
The NCI fruit and vegetable screener is a 10-item questionnaire about the types and amounts of fruits and vegetables eaten. Each item is scored from never (0) to 5 or more times per day (5). The composite score will be converted to cup equivalents, ranging from 0 to 84, with higher scores indicating greater fruit and vegetable intake in the last month.
Measured: Baseline to 10 weeks
Change in Mayo Clinic MINI EAT score
The MINI EAT is a 9-item questionnaire assessing dietary pattern and food intake. It is scored using a 6-point Likert scale, , ranging from 0 to 5. Because food servings vary by item, the anchor varies by item. Each item is multiplied by its coefficient. The weighted composite sore ranges from 49.3695 to 100, with higher scores indicating healthier eating.
Measured: Baseline to 10 weeks
Change in Fruit and Vegetable Self-Efficacy Scale (FVSEQ) score
The survey has 25 items asking about confidence in eating fruits and vegetables. It is scored using a 5-point Likert scale, where 1 = not at all confident and 5 = totally confident. Scores range from 25-125 with higher scores indicating greater confidence about eating fruits and vegetables.
Measured: Baseline to 10 weeks
Change in Family Metabolic Adaptation Questionnaire (FMAQ) score
FMAQ consists of 22 items on a five-point Likert scale. FMAQ will be used to evaluate the degree to which household constraints, healthy food access, and family stress influence individuals' cardiometabolic behaviors. 1 = never and 5 = always, with scores ranging from 22-110. Higher scores indicate greater environmental challenges to healthy behaviors.
Measured: Baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study startSep 2029 (estimated)
- Primary completionMay 2031 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Zhenhua Zhu, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896408
- Sponsor's protocol ID
- 2026-1255
- Other IDs
- 1R01MD021700, Protocol Version 8/15/26, UWMSN | COE | Civil and Enviro
- Acronym
- FRESH
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Metadata and Informed Consent Form (ICF)
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Healthy Food Access for Seniors in Food Deserts Through Robot-Assisted Delivery Systems
- ClinicalTrials.gov ID
- NCT07896408
- Acronym / sponsor ID
- FRESH / 2026-1255
- Conditions
- Elder
- Keywords
- rural community
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- Sep 2029 (estimated)
- Primary completion
- May 2031 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 27 Oct 2026 (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.
The purpose of this study is to find better ways to help older adults living in rural areas get access to fresh fruits and vegetables. The researchers want to find out whether delivering fresh produce to the participant's home using a delivery robot is a workable and acceptable way to help them eat more fruits and vegetables.
Participants will:
- Receive fresh fruits and vegetables delivered to their home twice a week by the Robot-Assisted Last-Mile Food Delivery (RALMFD) system; and,
- complete a journal and questionnaires.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elders living in rural communities | Experimental | Device: Robot-Assisted Last-Mile Food Delivery (RALMFD)Elders will receive food delivery by RALMFD |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Currently living in Portage County, WI
- Age 65 or above
- Able to communicate in English
- Willing to participate in a focus group
Key exclusion criteria (4 listed)
- Severe swallowing difficulties that require texture-modified diets
- Only a short-term stay in Portage (<12 weeks)
- Plan to travel for more than 4 weeks
- Allergy to any fruits or vegetables
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 |
|---|---|---|
| Robot-Assisted Last-Mile Food Delivery (RALMFD)RALMFD will deliver fresh fruits and vegetables twice per week for 10 weeks. | Device | Elders living in rural communities |
Primary outcome
Acceptability of RALMFD
Time frame: 10 weeks
Acceptability will be discussed during a focus group after the 10-week meal delivery period.
Feasibility of RALMFD
Time frame: 10 weeks
Feasibility will be measured by delivery completion rate
Usability of RALMFD
Time frame: 10 weeks
Usability will be measured using Brooke's System Usability Scale (SUS). Respondents rate 10 standard statements on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). The weighted composite score ranges from 1-100, with a higher score indicating better usability.
5 secondary outcomes
Change in Food Habit Questionnaire (FHQ) score
Time frame: Baseline to 10 weeks
Change in NCI Fruit and Vegetable Screener score
Time frame: Baseline to 10 weeks
Change in Mayo Clinic MINI EAT score
Time frame: Baseline to 10 weeks
Change in Fruit and Vegetable Self-Efficacy Scale (FVSEQ) score
Time frame: Baseline to 10 weeks
Change in Family Metabolic Adaptation Questionnaire (FMAQ) score
Time frame: Baseline to 10 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 29 Oct 2026.
- Individual participant dataSharing planned: Yes. Metadata and Informed Consent Form (ICF)
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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.
Wan-chin Kuo, PhD, RN contact
Zhenhua Zhu, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Assisted Last-Mile Food Delivery (RALMFD) in people with Elder, run by University of Wisconsin, Madison 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 4 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: opening soon, as of the sponsor's last update on 29 Oct 2026. 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?
Contact Wan-chin Kuo, PhD, RN (wkuo4@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of RALMFD (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2026.