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

May 9, 2024 updated by: Alison Gustafson
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • University Of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)
Time Frame: baseline and post intervention, approximately 12 weeks
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 food insecurity
Time Frame: 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.
baseline and post intervention, approximately 12 weeks
Change in blood pressure
Time Frame: 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.
baseline and post intervention, approximately 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alison Gustafson

Collaborators

Instacart Health
Kentucky Association of Health Plans

Investigators

  • Principal Investigator: Alison Gustafson, PhD, University Of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2023

Primary Completion (Actual)

May 8, 2024

Study Completion (Actual)

May 8, 2024

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 88696

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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