A Study of Fresh Produce and AI-Enabled Nutrition Support in Adults With Diabetes in Rural Appalachia

NCT07853703 | Active Not Recruiting DMC

• 1 other identifier: IRB #UTK-25-09091-XP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus Food Insecurity

Keywords

Rural Appalachia; Food as Medicine; Fresh Produce; Nutrition Support; Artificial Intelligence; Text Messaging; SMS; Diabetes Self-Management; Healthy Eating; Rural Health

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

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.

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.

Behavioral: Printed Nutrition Support; Other: Fresh produce

Interventions

AI-Enabled Nutrition Support BEHAVIORAL

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.

Fresh Produce + AI-Enabled SMS Support

Printed Nutrition Support BEHAVIORAL

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 Produce and Printed Nutrition Support

Fresh produce OTHER

Approximately 20 pounds of fresh fruits and vegetables delivered every two weeks for 12 weeks, for a total of six deliveries.

Fresh Produce + AI-Enabled SMS Support; Fresh Produce and Printed Nutrition Support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Tennessee, Knoxville: lead

Study Sites (1)

Mountain People Health Council

Oneida, Tennessee, 37741, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: October 2, 2026
• Study Start: July 15, 2025
• Primary Completion: September 24, 2026
• Study Completion: September 24, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)