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NCT06033664 Clinical Trial

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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06033664
Other study ID # 88696
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date May 8, 2024

Study information
Verified date May 2024
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date May 8, 2024
Est. primary completion date May 8, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Fresh Funds
Participants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks.

Locations
Country Name City State
United States University of Kentucky Lexington Kentucky

Sponsors (3)
Lead Sponsor Collaborator
Alison Gustafson Instacart Health, Kentucky Association of Health Plans

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with a percentage change in Hemoglobin A1C (HbgA1C) HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart. baseline and post intervention, approximately 12 weeks
Secondary Change in blood pressure Both systolic and diastolic blood pressure will be obtained baseline and post intervention by the healthcare provider from the medical chart. baseline and post intervention, approximately 12 weeks
Secondary Change in food insecurity 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. baseline and post intervention, approximately 12 weeks
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