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

Primary Purpose

Type 2 Diabetes Mellitus, Hypertension

Status

Not yet recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Fresh Funds

About this trial

This is an interventional supportive care trial for Type 2 Diabetes Mellitus focused on measuring Food Insecurity, Food as Medicine, Medicaid Adults

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Kentucky

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Grocery Prescription Program

Arm Description

Participants will receive the Fresh Funds through Instacart

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT06033664

First Posted

September 5, 2023

Last Updated

October 5, 2023

Sponsor

Alison Gustafson

Collaborators

Instacart Health, Kentucky Association of Health Plans

1. Study Identification

Unique Protocol Identification Number

NCT06033664

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 2023 (Anticipated)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Alison Gustafson

Collaborators

Instacart Health, Kentucky Association of Health Plans

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Hypertension

Keywords

Food Insecurity, Food as Medicine, Medicaid Adults

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Grocery Prescription Program

Arm Type

Experimental

Arm Description

Participants will receive the Fresh Funds through Instacart

Intervention Type

Behavioral

Intervention Name(s)

Fresh Funds

Other Intervention Name(s)

Grocery Prescription Program; Food As Medicine

Intervention Description

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.

Primary Outcome Measure Information:

Title

Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)

Description

HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart.

Time Frame

baseline and post intervention, approximately 12 weeks

Secondary Outcome Measure Information:

Title

Change in blood pressure

Description

Both systolic and diastolic blood pressure will be obtained baseline and post intervention by the healthcare provider from the medical chart.

Time Frame

baseline and post intervention, approximately 12 weeks

Title

Change in food insecurity

Description

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.

Time Frame

baseline and post intervention, approximately 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alison Gustafson, PhD

Phone

859-257-1309

alison.gustafson@uky.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alison Gustafson, PhD

Organizational Affiliation

University of Kentucky

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40506

Country

United States

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alison Gustafson, PhD

Phone

859-257-1309

alison.gustafson@uky.edu

12. IPD Sharing Statement

Learn more about this trial

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

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