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CompletedNCT06476990Updated Jun 27, 2024

Food Rx + Community Health Worker

An interventional study of Healthy food box in Diabetes Type 2, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled May 2021, registered Jun 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Food insecurity increases an individual's risk of poor health outcomes from some of the most costly and preventable chronic diseases, including type 2 diabetes. The goal of this interventional pilot study is to see if primary care patients with self-reported food insecurity and a diagnosis of type 2 diabetes who receive 12 weekly home deliveries of fresh produce and diabetes-appropriate, shelf-stable food will have improved diabetes management. Half of these patients also received support from a community health worker (CHW) including nutrition and cooking education and tailored assistance accessing food resources and other social needs (example: transportation). The investigators hypothesized that participants receiving support from a CHW along with food boxes would have greater improvement in health outcomes compared to those participants who received only food.

Read the detailed description

Food Rx + CHW is a 3-month community health worker led medically tailored grocery intervention for patients with self-reported food insecurity and a diagnosis of type 2 diabetes at one academic medical center in the Midwest United States. Prior to contact and recruitment, eligible patients were randomly assigned to receive 12 weekly food deliveries and support from a CHW (Food + CHW group) or food deliveries only (Food-only group).

All participants receive 12 weekly contactless deliveries of food. CHWs conduct three virtual study visits with participants to administer surveys and/or collect biomarker measurements at weeks 1, 12, and 24. No changes in the frequency of visits with the patient's provider are recommended. Virtual visit 1 involves the completion of study forms, assessment of household size for most meals, cultural preferences, food allergies, baseline cooking and eating habits, and assessment for knowledge and usage of local and/or federal food support programs. At week 12, participants use at home kits and devices (provided by the study) to measure and report their HbA1C, weight and blood pressure and complete post-intervention surveys on diet, knowledge and usage of food access programs and resources, and an anonymous feedback questionnaire on the strengths and opportunities for improvement in the program. At week 24, participants measured and reported their final HbA1C, weight and self-collected blood pressure result.

In addition to food, participants in the Food + CHW group also received 7 weekly virtual sessions with a CHW (four 90-minute ZOOM counseling sessions and three 30 to 60-minute check-in phone calls). CHW sessions included diabetes-appropriate cooking and nutrition education and personalized benefit enrollment and linkage to existing food access resources (for example Supplemental Nutrition Assistance Program, Double up Food Bucks, and Kansas Senior Farmers Market Vouchers).

Each weekly food box contained approximately $8 worth of shelf-stable food items purchased from a local food bank (beans, canned vegetables and no-sugar added fruit, shelf-stable dairy products, canned tuna, and whole grains) and $25 of fresh produce (5-7 items including leafy greens, peppers, potatoes, broccoli, carrots, zucchini, cauliflower, celery, cabbage, asparagus, apples, or strawberries). When seasonably available, fresh vegetables and fruit were sourced from local farmers via a local food hub. When local produce was not available, CHWs sourced produce from grocery stores.

02

Conditions studied

  • Diabetes Type 2
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 47 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • English or Spanish speaking,
  • Diagnosis of type 2 diabetes with a most recent HbA1C > 7,
  • Previously answered "yes" to the food insecurity needs question ("In the last 12 months, did you ever eat less than you should because there wasn't enough money for food?") on a SDOH screener during a patient care visit

Exclusion criteria

Exclusion Criteria:

  • Participant address was outside the delivery zone (the Kansas City Metro area),
  • Participant resides in a facility that provides all meals.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
47 participants (actual)

Study arms

  • Active comparator
    Food-only group

    Behavioral: Healthy food box

  • Experimental
    Food + CHW group

    Behavioral: Healthy food box

Interventions

  • BehavioralHealthy food box

    All participants received 12 weekly deliveries of food containing approximately $8 worth of shelf-stable food items purchased from a local food bank (beans, canned vegetables and no-sugar added fruit, shelf-stable dairy products, canned tuna, and whole grains) and $25 of fresh produce (5-7 items including leafy greens, peppers, potatoes, broccoli, carrots, zucchini, cauliflower, celery, cabbage, asparagus, apples, or strawberries). When seasonably available, fresh vegetables and fruit were sourced from local farmers via a local food hub. In addition to food, participants in the Food + CHW group also received 7 weekly virtual sessions with a CHW (four 90-minute ZOOM counseling sessions and three 30 to 60-minute check-in phone calls). CHW sessions included diabetes-appropriate cooking and nutrition education and personalized benefit enrollment and linkage to existing food access resources (for example SNAP, Double up Food Bucks, and Kansas Senior Farmers Market Vouchers).

    Also known as: Community health worker

06

What researchers measure

Primary outcomes

  1. Change from baseline in average blood glucose, as measured by Hemoglobin A1C

    Hemoglobin A1C point of care test

    Time frame: Baseline, 3 months, 6 months

07

Study locations

1 site
  • University of Kansas Medical Center
    Kansas City, Kansas 66106, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06476990
Lead sponsor
University of Kansas Medical Center
Collaborators
Blue Cross Blue Shield
Responsible party
Kristina Bridges (Research Assistant Professor, University of Kansas Medical Center) — Principal investigator
First posted
Jun 27, 2024
Start date
May 14, 2021
Primary completion
May 3, 2022
Completion
May 3, 2022
Last update
Jun 27, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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