search
Back to results

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

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fresh Funds for Mom's
Standard Medical care
Medically Tailored Frozen Meals
Sponsored by
Alison Gustafson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring Pregnancy, Food Insecurity, Food As Medicine

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of KentuckyRecruiting
  • U of L Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Grocery Prescription Program

Standard Medical Care

MTM (medically tailored frozen meals)

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
July 28, 2023
Last Updated
October 5, 2023
Sponsor
Alison Gustafson
Collaborators
Instacart Health, Kentucky Association of Health Plans
search

1. Study Identification

Unique Protocol Identification Number
NCT05979519
Brief Title
Fresh Carts for Mom's to Improve Food Security and Glucose Management
Official Title
Fresh Carts for Mom's to Improve Food Security and Glucose Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alison Gustafson
Collaborators
Instacart Health, Kentucky Association of Health Plans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes Mellitus
Keywords
Pregnancy, Food Insecurity, Food As Medicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Grocery Prescription Program
Arm Type
Experimental
Arm Description
Those randomized to the Grocery Prescription intervention will receive the Fresh Funds for Mom's through Instacart immediately
Arm Title
Standard Medical Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
MTM (medically tailored frozen meals)
Arm Type
Experimental
Arm Description
Those randomized to the MTM intervention will receive medically tailored frozen meals from Door Dash
Intervention Type
Behavioral
Intervention Name(s)
Fresh Funds for Mom's
Other Intervention Name(s)
Grocery Prescription Program; Food As Medicine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Medical care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medically Tailored Frozen Meals
Other Intervention Name(s)
MTM; Food As Medicine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage Change in fasting blood glucose
Description
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
Secondary Outcome Measure Information:
Title
Change in food insecurity
Description
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
Title
Change in self efficacy
Description
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
Title
Change in blood pressure
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alison Gustafson, PhD
Phone
859-257-1309
Email
alison.gustafson@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Gustafson, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Gustafson, PhD
Phone
859-257-1309
Email
alison.gustafson@uky.edu
Facility Name
U of L Health
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Sells
Phone
502-588-4720
Email
lauren.sells@uoflhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs