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

Study Overview
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Brief Summary
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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.

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

Conditions
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Type 2 Diabetes Mellitus, Hypertension

Intervention / Treatment
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* Behavioral: Fresh Funds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grocery Prescription Program<br>Participants will receive the Fresh Funds through Instacart | Behavioral: Fresh Funds<br>* 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.<br>* Other names: Grocery Prescription Program; Food As Medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Food Insecurity, Food as Medicine, Medicaid Adults