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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05979519
• Other study ID #: 86500
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: University of Kentucky
• Contact: Alison Gustafson, PhD
• Phone: 859-257-1309
• Email: alison.gustafson[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics
• Type 2 Diabetes Mellitus

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky
United States	U of L Health	Louisville	Kentucky

Sponsors (3)

Lead Sponsor	Collaborator
Alison Gustafson	Instacart Health, Kentucky Association of Health Plans

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage Change in fasting blood glucose	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	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
Secondary	Change in self efficacy	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
Secondary	Change in blood pressure	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