Meals for Me: Drop Shipment Versus Personally-delivered Meals for Diabetes Management

The University of Texas System (UT)

Status: Invitation-only

Conditions: Diabetes

Treatments: Behavioral: Waitlist; Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction; Behavioral: Medically tailored meals - Weekly delivery with no human interaction; Behavioral: Medically tailored meals - Daily delivery with human interaction

Study type: Interventional

Funder types: Other

Identifiers

NCT04277117

STUDY00002808-2022

Details and patient eligibility

About

This is a three-arm, parallel randomized trial study that will assess the impact of home delivery of medically-tailored meals (MTM) to community-dwelling older adults living with diabetes mellitus type 2 on measurements of diabetes control, mental health, and other exploratory outcomes such as healthcare use.

Full description

This study aims to:

1. Assess the impact of medically-tailored meals program on diabetes management and mental health in comparison to usual care without such program.
2. Assess the differential impact of two delivery models being considered for payment by the health system on diabetes management and mental health: once-a-week frozen drop shipment model versus daily warm meal delivery model that is more complex to implement but allows for human connection and easier meal preparation.

Implementation of program:

Meals on Wheels (MoW) of Central Texas (MOWCTX) in Austin, Texas, will provide the meals and delivery service in this study. Meals are all medically tailored (diabetes friendly) and design by MOWCT's team of Registered Dietitians.

Participants:

Older adults, 55 and over, living in the Austin city limits with poorly controlled diabetes; Inclusion criteria:

• Adult 55-90
• Hemoglobin A1C >=7.5 (as measured at baseline)
• Living in Austin city limits and within a MOWCTX daily delivery route
• Interested and available to receive meals during delivery window time
• Has access to a freezer and a microwave
• Pass a MOWCTX background check

Trial:

Eligible participants will be recruited from selected Federally Qualified Health Centers in the Austin area, MOWCTX clients on waitlist, and other (e.g. Medicaid recipients).

Participants will be randomized to one of three arms: 1) Waitlisted control; 2) Weekly frozen drop shipment of MTM 3) Daily Warm delivery of MTM with in-person check-ins during delivery.

Phase 1 (first 6 months) The intervention arms will receive their assigned method of meal delivery (weekly frozen or daily warm), for a total of 10 meals a week, including two main meals per day and snacks. The control arm will not receive any meals during this phase. All arms will receive printed educational materials at baseline.

Phase 2 (month 6 to 12) All arms will receive 2-4 meals a week (depending on participant's availability) delivered via the traditional meal services from MOWCTX, which includes one hot meal plus a snack delivered daily. Meal delivery can also include 1 or more frozen meals to account for a total of 5 meals per week.

Primary outcome is Hemoglobin A1C and secondary outcomes include depression as measured by PHQ-8 and other mental health measures.

Enrollment: 320 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult 55-90
• Hemoglobin A1c ≥7.5%
• Living in Austin city limits and within a MOWCTX daily delivery route
• Interested and available to receive meals during delivery window time
• Has access to a freezer and a microwave
• Pass a MOWCTX background check

Exclusion criteria

• Participated in MOW program in previous 3 months.
• Has any of the following: dementia or cognitive impairment, diagnosis of heart failure, cirrhosis, or active cancer
• Is receiving hospice care
• Does not pass a MOWCTX background check

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 3 patient groups

Waitlisted control

Other group

Description:

Phase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * No meal delivery Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week

Treatment:

Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction

Behavioral: Waitlist

"Daily Warm" MTM in-person delivery

Experimental group

Description:

Phase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * 10 medically-tailored meals (MTM) per week, delivered 3-5x per week Mon-Fri * Each delivery day, 1 hot and 1 frozen + snack delivered to the participant's home by trained volunteers and/or paid delivery drivers who provide human interaction. Depending on the participant's availability (3-5 days/week), more frozen meals will be given one day to account for a total of 10 meals every week. Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week

Treatment:

Behavioral: Medically tailored meals - Daily delivery with human interaction

Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction

"Weekly Frozen" MTM drop shipment

Experimental group

Description:

Phase 1 (6 months, months 1-6): * Educational materials on healthy eating for diabetes * 10 medically-tailored meals (MTM) delivered once a week * Each week all meals are frozen. * Meals are shipped to the participant's home with no human interaction Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week.

Treatment:

Behavioral: Medically tailored meals - Weekly delivery with no human interaction

Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction