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

Sponsor
Alison Gustafson (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05979519
Collaborator
Instacart Health (Other), Kentucky Association of Health Plans (Other)
120
2
3
5
60
11.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Fresh Funds for Mom's
  • Behavioral: Standard Medical care
  • Behavioral: Medically Tailored Frozen Meals
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Fresh Carts for Mom's to Improve Food Security and Glucose Management
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Grocery Prescription Program

Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately

Behavioral: Fresh 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.
Other Names:
  • Grocery Prescription Program; Food As Medicine
  • Active Comparator: 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.

    Behavioral: Standard 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.

    Experimental: MTM (medically tailored frozen meals)

    Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash

    Behavioral: Medically 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.
    Other Names:
  • MTM; Food As Medicine
  • Outcome Measures

    Primary Outcome Measures

    1. Change in glucose measurements [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 Outcome Measures

    1. 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.

    2. 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.

    3. Change in blood pressure [baseline and post intervention, approximately 12 weeks]

      Blood pressure will be obtained baseline and post intervention (prior to delivery) by the healthcare provider from the medical chart.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kentucky Lexington Kentucky United States 40506
    2 U of L Health Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • Alison Gustafson
    • Instacart Health
    • Kentucky Association of Health Plans

    Investigators

    • Principal Investigator: Alison Gustafson, PhD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alison Gustafson, Professor, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT05979519
    Other Study ID Numbers:
    • 86500
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 7, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alison Gustafson, Professor, University of Kentucky
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 7, 2023