Clinical trial NCT05979519: Fresh Carts for Mom's to Improve Food Security and Glucose Management
Official title: Fresh Carts for Mom's to Improve Food Security and Glucose Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes Mellitus in Pregnancy
Type 2 Diabetes Mellitus
Keywords: Pregnancy
Food Insecurity
Food As Medicine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Instacart Health
name: Kentucky Association of Health Plans
First posted: 2023-08-07
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage Change in fasting blood glucose
timeFrame: baseline and post intervention, approximately 12 weeks
Secondary outcomes:
measure: Change in food insecurity
timeFrame: baseline and post intervention, approximately 12 weeks
measure: Change in self efficacy
timeFrame: baseline and post intervention, approximately 12 weeks
measure: Change in blood pressure
timeFrame: baseline and post intervention, approximately 12 weeks
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Louisville
country: United States
facility: U of L Health
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Alison Gustafson, PhD
role: PRINCIPAL_INVESTIGATOR
References: