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

NCT05979519 | Completed

• 1 other identifier: 86500
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Gestational Diabetes Mellitus in Pregnancy; Type 2 Diabetes Mellitus

Keywords

Pregnancy; Food Insecurity; Food As Medicine

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and post intervention, approximately 12 weeks

Secondary Outcomes (3)

• Change in food insecurity

  baseline and post intervention, approximately 12 weeks

• Change in self efficacy

  baseline and post intervention, approximately 12 weeks

• Change in blood pressure

  baseline and post intervention, approximately 12 weeks

Study Arms (3)

Grocery Prescription Program

EXPERIMENTAL

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

Behavioral: Fresh Funds for Mom's

Standard Medical Care

ACTIVE COMPARATOR

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

MTM (medically tailored frozen meals)

EXPERIMENTAL

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

Behavioral: Medically Tailored Frozen Meals

Interventions

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.

Also known as: Grocery Prescription Program; Food As Medicine

Grocery Prescription Program

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.

Standard Medical Care

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.

Also known as: MTM; Food As Medicine

MTM (medically tailored frozen meals)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alison Gustafson: lead
• Instacart Health: collaborator
• Kentucky Association of Health Plans: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

U of L Health

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Food; Dosage Forms; myotubularin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• Alison Gustafson, PhD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: September 26, 2023
• Primary Completion: April 28, 2024
• Study Completion: April 28, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)