Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Hypertension
• Interventions: Behavioral: Fresh Funds

• Registration Number: NCT06033664
• Lead Sponsor: Alison Gustafson

Brief Summary

The purpose of this study is to evaluate the effectiveness of a grocery prescription program in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will enroll in Instacart Fresh Funds program. Once enrolled each week participants will select foods that are eligible in the Fresh Funds Program to be delivered to their home for 12 weeks. Participants will also participate in a survey at the beginning of the study and at the end of the study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Study First Submitted QC: 2023-09-05
• Study First Posted: 2023-09-13
• Study Start: 2023-11-06
• Status Verified: 2024-05
• Primary Completion: 2024-05-08
• Study Completion: 2024-05-08
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Diagnosis of Type 2 Diabetes Mellitus, hemoglobin A1c = 7.0% and = 12.0% in last 12 months, or diagnosis of hypertension
• Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
• English speaking
• No plans to move from the area for at least 1 year
• Willing and able to accept text messages
• Free living to the extent that participant has control over dietary intake
• Willing and able to provide written informed consent and participate in all study activities.

Exclusion Criteria

• Participant in diabetes, nutrition, or weight research intervention in last 12 months
• Another member of the household is already enrolled in this study
• Considering bariatric surgery in the next year or prior bariatric surgery
• Lack of safe, stable residence and ability to store meals

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Grocery Prescription Program	Fresh Funds	Participants will receive the Fresh Funds through Instacart

Primary Outcome Measures

Name	Time	Method
Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)	baseline and post intervention, approximately 12 weeks	HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	baseline and post intervention, approximately 12 weeks	Both systolic and diastolic blood pressure will be obtained baseline and post intervention by the healthcare provider from the medical chart.
Change in food insecurity	baseline and post intervention, approximately 12 weeks	The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity.

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States