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

Not Applicable

Completed

• Conditions: Gestational Diabetes Mellitus in Pregnancy; Type 2 Diabetes Mellitus
• Interventions: Behavioral: Medically Tailored Frozen Meals; Behavioral: Fresh Funds for Mom's; Behavioral: Standard Medical care

• Registration Number: NCT05979519
• Lead Sponsor: Alison Gustafson

Brief 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.

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 Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Study Start: 2023-09-26
• Primary Completion: 2024-04-28
• Study Completion: 2024-04-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTM (medically tailored frozen meals)	Medically Tailored Frozen Meals	Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash
Grocery Prescription Program	Fresh Funds for Mom's	Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately
Standard Medical Care	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.

Primary Outcome Measures

Name	Time	Method
Percentage Change in fasting blood glucose	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.

Secondary Outcome Measures

Name	Time	Method
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.
Change in self efficacy	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.
Change in blood pressure	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.

Trial Locations

Locations (2)

U of L Health; 🇺🇸 Louisville, Kentucky, United States

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States