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Completed

NCT Number: NCT05979519

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

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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Key information

Conditions

Gestational Diabetes Mellitus in Pregnancy Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky, Lexington, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fresh Funds for Mom's

Behavioral

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.

Other names: Grocery Prescription Program; Food As Medicine

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

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.

Other names: MTM; Food As Medicine

Primary outcomes

  1. Percentage Change in fasting blood glucose

    Time frame: 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

  1. Change in food insecurity

    Time frame: 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.

  2. Change in self efficacy

    Time frame: 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.

  3. Change in blood pressure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alison Gustafson

Other

Collaborators

  • Instacart Health
  • Kentucky Association of Health Plans

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Jun 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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