An interventional study of Fresh Funds for Mom's and Standard Medical care in Gestational Diabetes Mellitus in Pregnancy and Type 2 Diabetes Mellitus, sponsored by Alison Gustafson. Completed at 2 sites in United States. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by Alison Gustafson · Not applicable, Interventional, and Supportive 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.
842 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.
This study's enrollment of 22 is below the median of 110 across 549 interventional studies indexed under Diabetes, Gestational.
Browse Diabetes, Gestational studies →Alison Gustafson is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately
Behavioral: Fresh Funds for Mom's
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.
Behavioral: Standard Medical care
Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash
Behavioral: Medically Tailored Frozen Meals
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.
Also known as: Grocery Prescription Program; Food As Medicine
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.
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.
Also known as: MTM; Food As Medicine
Percentage Change in fasting blood glucose
Fasting blood glucose obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.
Time frame: baseline and post intervention, approximately 12 weeks
Change in food insecurity
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.
Time frame: baseline and post intervention, approximately 12 weeks
Change in self efficacy
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.
Time frame: baseline and post intervention, approximately 12 weeks
Change in blood pressure
Diastolic and systolic Blood pressure will be obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.
Time frame: baseline and post intervention, approximately 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Alison Gustafson