Viewing Study NCT06476990



Ignite Creation Date: 2024-07-17 @ 12:01 PM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06476990
Status: COMPLETED
Last Update Posted: 2024-06-27
First Post: 2024-06-20

Brief Title: Food Rx Community Health Worker
Sponsor: University of Kansas Medical Center
Organization: University of Kansas Medical Center

Study Overview

Official Title: Food Rx CHW a Community Health Worker-led Medically Tailored Grocery Intervention to Address Food Insecurity and Type 2 Diabetes
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Food insecurity increases an individuals 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
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 andor collect biomarker measurements at weeks 1 12 and 24 No changes in the frequency of visits with the patients 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 andor 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None