Fresh Carts for Mom's to Improve Food Security and Glucose Management

June 4, 2024 updated by: Alison Gustafson
This study will look at the benefit of decreasing food insecurity and improving glucose control among women who either report gestational diabetes (GDM) at 20-28-weeks or have type 2 diabetes (T2DM) with a confirmed pregnancy. Participants will receive a grocery prescription with delivery through Instacart at the start of the study or after 12 weeks or frozen medically tailored meals delivered from Door Dash. Researchers will compare the grocery prescription program, MTM (medically tailored meals), relative to standard of care to see if the impact on these food as medicine programs can improve glucose control over 12-weeks as compared to standard of care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women who have a diagnosis of gestational diabetes (GDM) or type 2 diabetes (T2DM) and who report food insecurity using the Hunger Vital Signs Screener will be recruited to participate in a comparative study across two urban communities. One arm will receive a grocery prescription program from Instacart Health to be spent on eligible healthy food items based on My Diabetes Plate. The other arm will receive 10 frozen medically tailored meals delivered to their door each week. The meals are based on diabetes guidelines and are culturally appropriate. Meals are created by a local nonprofit food pantry, Dare to Care, in Louisville, Kentucky and delivered via a partnership with Door Dash - Project Dash. Women will be recruited initially from a registered nurse who works at the clinic sites. The study team will then enroll participants after eligibility screening and conduct further onboarding into the food as medicine package based on locations.

Study Type

Interventional

Enrollment (Actual)

22

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
      • Louisville, Kentucky, United States, 40202
        • U of L Health

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 gestational diabetes or type 2 diabetes
  • answer affirmative to one of two questions on the Hunger Vital Signs
  • viable pregnancy
  • lives in a service area of Instacart delivery
  • has a phone or computer which allows ordering food for delivery

Exclusion Criteria:

  • Does not speak English
  • Does not have a phone, tablet, or computer to order groceries for Instacart
  • Plans to move within the next 3 months

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Grocery Prescription Program
Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately
Behavioral: Fresh Funds for Mom's

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.

Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then 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
Active Comparator: Standard Medical Care
the delayed control group will receive their usual care through their healthcare provider and then participate in Fresh Funds or MTM after the initial 12-weeks of intervention.
Behavioral: Standard Medical care
Those in standard care will maintain usual care with their healthcare provider. The standard care arm after the initial 12-weeks and post intervention survey will then select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks or be provided the medically tailored meals for 12 weeks.
Experimental: MTM (medically tailored frozen meals)
Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash
Behavioral: Medically Tailored Frozen Meals
Participants will enroll in the MTM program. Once enrolled participants will receive 10 frozen meals delivered by Door Dash to their home each week for 12 weeks.
Other Names:
  • MTM; Food As Medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage Change in fasting blood glucose
Time Frame: baseline and post intervention, approximately 12 weeks
Fasting blood glucose obtained baseline and post intervention (prior to delivery) 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 self efficacy
Time Frame: baseline and post intervention, approximately 12 weeks
The self efficacy scale for diabetes measures the confidence in managing diabetes. Scores range from 1 to 10 with a higher score indicating greater confidence in managing diabetes.
baseline and post intervention, approximately 12 weeks
Change in blood pressure
Time Frame: baseline and post intervention, approximately 12 weeks
Diastolic and systolic Blood pressure will be obtained baseline and post intervention (prior to delivery) 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)

September 26, 2023

Primary Completion (Actual)

April 28, 2024

Study Completion (Actual)

April 28, 2024

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 4, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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