| Registry | NCT05979519 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, supportive care |
| Enrollment | 22 (Actual) |
| Sponsor | Alison Gustafson (Other); collaborators: Instacart Health, Kentucky Association of Health Plans |
| Conditions | Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus |
| Interventions | Fresh Funds for Mom's, Standard Medical care, Medically Tailored Frozen Meals (Behavioral) |
| Dates | start 2023-09-26, primary completion 2024-04-28, completion 2024-04-28, first posted 2023-08-07, last updated 2024-06-05 |
| Locations | 2 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Gestational Diabetes Mellitus in Pregnancy All trials for Type 2 Diabetes Mellitus All trials of Fresh Funds for Mom's All trials of Standard Medical care
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Grocery Prescription Program | Experimental | Behavioral: 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 | Active comparator | Behavioral: 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. |
| MTM (medically tailored frozen meals) | Experimental | Behavioral: Medically Tailored Frozen Meals | Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash |
Sex: Female, ages: 18 Years to 55 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| University of Kentucky | Lexington, Kentucky | United States | |
| U of L Health | Louisville, Kentucky | United States |