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

NCT ID: NCT04277117

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2026-08-01

Brief Summary

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.

Detailed 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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Waitlisted control

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

Group Type: OTHER

Waitlist

Intervention Type: BEHAVIORAL

Phase 1 (6 months)

• Educational materials on such topics as healthy eating for diabetes.

Medically tailored meals - Standard MOWCTX delivery with human interaction

Intervention Type: BEHAVIORAL

Phase 2 (6 months)

• Food: 5 MTM a week plus snacks. Planned to offer approx. 600 kcal per day.
• Delivery: 2 to 4x a week (depending on participant availability), including daily delivery of 1 hot MTM plus a cold bag (with healthy snacks), with one day or more (depending on the 2 to 4x a week delivery schedule participant is on) also including 1 frozen MTM to total 5 meals per week.
• Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction ("check-in") with the participant.
• MOWCTX Standard Wraparounds: Participants will have access to a case manager to assist with additional resources within the community and for additional support if needed (e.g., grocery shopping assistance, home repairs, and pet care).

"Daily Warm" MTM in-person delivery

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

Group Type: EXPERIMENTAL

Medically tailored meals - Daily delivery with human interaction

Intervention Type: BEHAVIORAL

Phase 1 (6 months)

• Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions.
• Food: 10 MTM a week: mix of hot and frozen, and 5-10 snacks per week. Meals and snacks offer approx. 1200 kcal per day.
• Delivery: 3 to 5x per week. Each delivery day, one meal is warm, the other is frozen. 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.
• Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction (at minimum in-person hand-off & visual check) with the participant.

Medically tailored meals - Standard MOWCTX delivery with human interaction

Intervention Type: BEHAVIORAL

Phase 2 (6 months)

• Food: 5 MTM a week plus snacks. Planned to offer approx. 600 kcal per day.
• Delivery: 2 to 4x a week (depending on participant availability), including daily delivery of 1 hot MTM plus a cold bag (with healthy snacks), with one day or more (depending on the 2 to 4x a week delivery schedule participant is on) also including 1 frozen MTM to total 5 meals per week.
• Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction ("check-in") with the participant.
• MOWCTX Standard Wraparounds: Participants will have access to a case manager to assist with additional resources within the community and for additional support if needed (e.g., grocery shopping assistance, home repairs, and pet care).

"Weekly Frozen" MTM drop shipment

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.

Group Type: EXPERIMENTAL

Medically tailored meals - Weekly delivery with no human interaction

Intervention Type: BEHAVIORAL

Phase 1 (6 months)

• Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions.
• Food: 10 frozen MTM and 5-10 healthy snacks (with the goal of providing 2 meals and 1-2 snacks for 5 days of the week). Meals and snacks offer approx. 1200 kcal per day. Nutritionally similar and frequently the same meal as that delivered in the daily delivery arm.
• Delivery: 1x per week shipment.
• Engagement: Meals are shipped to the participant's home. No human engagement.

Medically tailored meals - Standard MOWCTX delivery with human interaction

Intervention Type: BEHAVIORAL

Phase 2 (6 months)

• Food: 5 MTM a week plus snacks. Planned to offer approx. 600 kcal per day.
• Delivery: 2 to 4x a week (depending on participant availability), including daily delivery of 1 hot MTM plus a cold bag (with healthy snacks), with one day or more (depending on the 2 to 4x a week delivery schedule participant is on) also including 1 frozen MTM to total 5 meals per week.
• Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction ("check-in") with the participant.
• MOWCTX Standard Wraparounds: Participants will have access to a case manager to assist with additional resources within the community and for additional support if needed (e.g., grocery shopping assistance, home repairs, and pet care).

Interventions

Waitlist

Phase 1 (6 months)

• Educational materials on such topics as healthy eating for diabetes.

Intervention Type: BEHAVIORAL

Medically tailored meals - Daily delivery with human interaction

Phase 1 (6 months)

• Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions.
• Food: 10 MTM a week: mix of hot and frozen, and 5-10 snacks per week. Meals and snacks offer approx. 1200 kcal per day.
• Delivery: 3 to 5x per week. Each delivery day, one meal is warm, the other is frozen. 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.
• Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction (at minimum in-person hand-off & visual check) with the participant.

Intervention Type: BEHAVIORAL

Medically tailored meals - Weekly delivery with no human interaction

Phase 1 (6 months)

• Educational materials on such topics as healthy eating for diabetes, in addition to materials on meal planning and instructions.
• Food: 10 frozen MTM and 5-10 healthy snacks (with the goal of providing 2 meals and 1-2 snacks for 5 days of the week). Meals and snacks offer approx. 1200 kcal per day. Nutritionally similar and frequently the same meal as that delivered in the daily delivery arm.
• Delivery: 1x per week shipment.
• Engagement: Meals are shipped to the participant's home. No human engagement.

Intervention Type: BEHAVIORAL

Medically tailored meals - Standard MOWCTX delivery with human interaction

Phase 2 (6 months)

• Food: 5 MTM a week plus snacks. Planned to offer approx. 600 kcal per day.
• Delivery: 2 to 4x a week (depending on participant availability), including daily delivery of 1 hot MTM plus a cold bag (with healthy snacks), with one day or more (depending on the 2 to 4x a week delivery schedule participant is on) also including 1 frozen MTM to total 5 meals per week.
• Engagement: MOWCTX's trained volunteers and/or paid delivery drivers delivering the meals will have a brief social interaction ("check-in") with the participant.
• MOWCTX Standard Wraparounds: Participants will have access to a case manager to assist with additional resources within the community and for additional support if needed (e.g., grocery shopping assistance, home repairs, and pet care).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meals on Wheels Central Texas

OTHER

Sponsor Role: collaborator

University of Texas at Austin

OTHER

Sponsor Role: lead

Responsible Party

Maninder Kahlon

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maninder K Kahlon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Austin

Locations

Meals on Wheels Central Texas

Austin, Texas, United States

CommUnityCare Health Centers (all Austin clinics)

Austin, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00002808-2022

Identifier Type: -

Identifier Source: org_study_id