Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus
Conditions
Keywords
Pregnancy, Food Insecurity, Food As Medicine
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.
Interventions
BEHAVIORALFresh 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.
BEHAVIORALStandard 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.
BEHAVIORALMedically 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.
Sponsors
Instacart Health
Kentucky Association of Health Plans
Alison Gustafson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed