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

Sponsor

Alison Gustafson (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06033664

Collaborator

Instacart Health (Other), Kentucky Association of Health Plans (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

11.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus Hypertension	Behavioral: Fresh Funds	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Grocery Prescription Program Participants will receive the Fresh Funds through Instacart	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. Other Names: Grocery Prescription Program; Food As Medicine

Arm

Intervention/Treatment

Experimental: Grocery Prescription Program

Participants will receive the Fresh Funds through Instacart

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.

Other Names:

Grocery Prescription Program; Food As Medicine

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts 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