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

Alison Gustafson

Status: Completed

Conditions: Gestational Diabetes Mellitus in Pregnancy; Type 2 Diabetes Mellitus

Treatments: Behavioral: Fresh Funds for Mom's; Behavioral: Medically Tailored Frozen Meals; Behavioral: Standard Medical care

Study type: Interventional

Funder types: Other

Identifiers

NCT05979519

86500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 3 patient groups

Grocery Prescription Program

Experimental group

Description:

Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately

Treatment:

Behavioral: Fresh Funds for Mom's

Standard Medical Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Medical care

MTM (medically tailored frozen meals)

Experimental group

Description:

Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash

Treatment:

Behavioral: Medically Tailored Frozen Meals