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

NCT05979519 — Not applicable, Completed, 22 participants, Alison Gustafson

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RegistryNCT05979519
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, supportive care
Enrollment22 (Actual)
SponsorAlison Gustafson (Other); collaborators: Instacart Health, Kentucky Association of Health Plans
ConditionsGestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus
InterventionsFresh Funds for Mom's, Standard Medical care, Medically Tailored Frozen Meals (Behavioral)
Datesstart 2023-09-26, primary completion 2024-04-28, completion 2024-04-28, first posted 2023-08-07, last updated 2024-06-05
Locations2 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

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Grocery Prescription ProgramExperimentalBehavioral: Fresh Funds for Mom'sThose randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately
Standard Medical CareActive comparatorBehavioral: Standard Medical carethe 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)ExperimentalBehavioral: Medically Tailored Frozen MealsThose randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash
  • Fresh Funds for Mom's (Behavioral), also known as Grocery Prescription Program; Food As Medicine: 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.
  • Standard Medical care (Behavioral): 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.
  • Medically Tailored Frozen Meals (Behavioral), also known as MTM; Food As Medicine: 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.

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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.

+Eligibility

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

+Locations (2)

FacilityCityCountryStatus
University of KentuckyLexington, KentuckyUnited States
U of L HealthLouisville, KentuckyUnited States

+Investigators