Diabete MellitusSTARTNCT07853703
A Study of Fresh Produce and AI-Enabled Nutrition Support in Adults With Diabetes in Rural Appalachia
A study testing AI-Enabled Nutrition Support, Printed Nutrition Support and Fresh produce in people with Diabete Mellitus, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial summary
This pilot study evaluated a 12-week program for adults with type 2 diabetes and food insecurity living in rural Tennessee. Participants were randomly assigned to one of two groups. The program provided fresh fruits and vegetables delivered to participants' homes and nutrition support through text messages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabete Mellitus
- What is being tested?
- AI-Enabled Nutrition Support, Printed Nutrition Support and Fresh produce
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2025to 24 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Diagnosis of type 2 diabetes for at least 6 months
- HbA1c ≥9%
- Food insecurity based on the 2-item Hunger Vital Sign
- Residence in Scott County, Tennessee
- Access to SMS text messaging or voice communication
- Ability to use the study technology independently
- Ability to provide informed consent in English
Who cannot join
- Type 1 diabetes
- End-stage renal disease or receipt of dialysis
- Medical or other conditions that would prevent study participation
- Clinical circumstances that could interfere with the intervention or outcome assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain People Health Council
Oneida, Tennessee, 37741
About this study
Official title: The START Project: A Study of Fresh Produce Delivery and Artificial Intelligence-Enabled Nutrition Support for Food-Insecure Adults With Diabetes in Rural Appalachia
This pilot study evaluated a 12-week program for adults with type 2 diabetes and food insecurity living in rural Tennessee. Participants were randomly assigned to one of two groups. The program provided fresh fruits and vegetables delivered to participants' homes and nutrition support through text messages. The text messages provided information and support related to healthy eating, using and preparing fresh produce, meal planning, goal setting, and community resources. The study examined whether the program was feasible and acceptable to participants and explored changes in diabetes management, food security, eating behaviors, and health outcomes.
Read the detailed description
This pilot randomized controlled trial evaluated the feasibility, acceptability, and preliminary effects of an intervention integrating home-delivered fresh produce with AI-enabled SMS support among adults with type 2 diabetes, food insecurity, and elevated HbA1c living in rural Appalachia.
Participants were randomized to an intervention or waitlist control group. The intervention group received approximately 20 pounds of fresh fruits and vegetables every two weeks for 12 weeks, along with AI-enabled SMS support addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, behavioral goal setting, and community resources. The waitlist control group received the fresh-produce intervention after the initial study period.
The study assessed implementation outcomes, participant engagement, food security, dietary and diabetes self-management outcomes, psychosocial outcomes, and HbA1c.
- Conditions
- Diabete Mellitus
- Being tested
- AI-Enabled Nutrition Support, Printed Nutrition Support, Fresh produce
- Keywords
- Rural Appalachia, Food as Medicine, Fresh Produce, Nutrition Support, Artificial Intelligence, Text Messaging, SMS, Diabetes Self-Management, Healthy Eating, Rural Health
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Enabled Nutrition SupportBehavioural
Participants received AI-enabled SMS support addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, behavioral goal setting, and community resources. The SMS support was designed to provide ongoing, accessible nutrition and diabetes self-management support throughout the intervention period.
Printed Nutrition SupportBehavioural
Participants received printed recipes and educational materials addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, goal setting, and community resources.
Fresh produceOther
Approximately 20 pounds of fresh fruits and vegetables delivered every two weeks for 12 weeks, for a total of six deliveries.
| Study group | Role | What they receive |
|---|---|---|
| Fresh Produce + AI-Enabled SMS Support | Experimental | Participants received approximately 20 pounds of fresh fruits and vegetables every two weeks for 12 weeks (six deliveries) plus AI-enabled SMS support addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, behavioral goal setting, and community resources. Receives: Behavioral: AI-Enabled Nutrition Support; Other: Fresh produce |
| Fresh Produce and Printed Nutrition Support | Other | Participants received approximately 20 pounds of fresh fruits and vegetables every two weeks for 12 weeks (six deliveries) plus printed recipes and educational materials addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, goal setting, and community resources. Receives: Behavioral: Printed Nutrition Support; Other: Fresh produce |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Feasibility of delivering the fresh-produce and AI-enabled SMS intervention, assessed using the Feasibility of Intervention Measure (FIM). Higher scores indicate greater perceived feasibility.
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 posted2 Oct 2026
- Study start15 Jul 2025
- Primary completion24 Sep 2026
- Study completion24 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853703
- Sponsor's protocol ID
- IRB #UTK-25-09091-XP
- Acronym
- START
- Status last verified
- Sep 2026
- First submitted
- 18 Sep 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared because the study involves a small, geographically specific rural population and sensitive health and social information, which may increase the risk of participant re-identification.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The START Project: A Study of Fresh Produce Delivery and Artificial Intelligence-Enabled Nutrition Support for Food-Insecure Adults With Diabetes in Rural Appalachia
- ClinicalTrials.gov ID
- NCT07853703
- Acronym / sponsor ID
- START / IRB #UTK-25-09091-XP
- Conditions
- Diabete Mellitus
- Keywords
- Rural Appalachia, Food as Medicine, Fresh Produce, Nutrition Support, Artificial Intelligence, Text Messaging, SMS, Diabetes Self-Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 24 Sep 2026 (actual)
- Study completion
- 24 Sep 2026 (actual)
- First posted
- 2 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.
This pilot study evaluated a 12-week program for adults with type 2 diabetes and food insecurity living in rural Tennessee. Participants were randomly assigned to one of two groups. The program provided fresh fruits and vegetables delivered to participants' homes and nutrition support through text messages. The text messages provided information and support related to healthy eating, using and preparing fresh produce, meal planning, goal setting, and community resources. The study examined whether the program was feasible and acceptable to participants and explored changes in diabetes management, food security, eating behaviors, and health outcomes.
Detailed description
This pilot randomized controlled trial evaluated the feasibility, acceptability, and preliminary effects of an intervention integrating home-delivered fresh produce with AI-enabled SMS support among adults with type 2 diabetes, food insecurity, and elevated HbA1c living in rural Appalachia.
Participants were randomized to an intervention or waitlist control group. The intervention group received approximately 20 pounds of fresh fruits and vegetables every two weeks for 12 weeks, along with AI-enabled SMS support addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, behavioral goal setting, and community resources. The waitlist control group received the fresh-produce intervention after the initial study period.
The study assessed implementation outcomes, participant engagement, food security, dietary and diabetes self-management outcomes, psychosocial outcomes, and HbA1c.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh Produce + AI-Enabled SMS Support | Experimental | Behavioral: AI-Enabled Nutrition Support, Other: Fresh produceParticipants received approximately 20 pounds of fresh fruits and vegetables every two weeks for 12 weeks (six deliveries) plus AI-enabled SMS support addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, behavioral goal setting, and community resources. |
| Fresh Produce and Printed Nutrition Support | Other | Behavioral: Printed Nutrition Support, Other: Fresh produceParticipants received approximately 20 pounds of fresh fruits and vegetables every two weeks for 12 weeks (six deliveries) plus printed recipes and educational materials addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, goal setting, and community resources. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 years or older
- Diagnosis of type 2 diabetes for at least 6 months
- HbA1c ≥9%
- Food insecurity based on the 2-item Hunger Vital Sign
- Residence in Scott County, Tennessee
Key exclusion criteria (4 listed)
- Type 1 diabetes
- End-stage renal disease or receipt of dialysis
- Medical or other conditions that would prevent study participation
- Clinical circumstances that could interfere with the intervention or outcome assessment
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 |
|---|---|---|
| AI-Enabled Nutrition SupportParticipants received AI-enabled SMS support addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, behavioral goal setting, and community resources. The SMS support was designed to provide ongoing, accessible nutrition and diabetes self-management support throughout the intervention period. | Behavioural | Fresh Produce + AI-Enabled SMS Support |
| Printed Nutrition SupportParticipants received printed recipes and educational materials addressing healthy eating, produce use and preparation, meal planning, shopping and budgeting, goal setting, and community resources. | Behavioural | Fresh Produce and Printed Nutrition Support |
| Fresh produceApproximately 20 pounds of fresh fruits and vegetables delivered every two weeks for 12 weeks, for a total of six deliveries. | Other | Fresh Produce + AI-Enabled SMS Support, Fresh Produce and Printed Nutrition Support |
Primary outcome
Intervention Feasibility
Time frame: 12 weeks
Feasibility of delivering the fresh-produce and AI-enabled SMS intervention, assessed using the Feasibility of Intervention Measure (FIM). Higher scores indicate greater perceived feasibility.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared because the study involves a small, geographically specific rural population and sensitive health and social information, which may increase the risk of participant re-identification.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Enabled Nutrition Support, Printed Nutrition Support and Fresh produce in people with Diabete Mellitus, run by The University of Tennessee, Knoxville 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 8 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: finished, as of the sponsor's last update on 14 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intervention Feasibility (time frame: 12 weeks). 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 14 Oct 2026.