Food Rx + Community Health Worker

NCT06476990 | Completed

• 1 other identifier: STUDY00144654
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Type 2

Outcome Measures

Primary Outcomes (1)

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

  Hemoglobin A1C point of care test

  Baseline, 3 months, 6 months

Study Arms (2)

Food-only group

ACTIVE COMPARATOR

Behavioral: Healthy food box

Food + CHW group

EXPERIMENTAL

Behavioral: Healthy food box

Interventions

Healthy food box BEHAVIORAL

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

Food + CHW group; Food-only group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Blue Cross Blue Shield: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66106, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 27, 2024
• Study Start: May 14, 2021
• Primary Completion: May 3, 2022
• Study Completion: May 3, 2022
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)