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

NCT04277117 | Enrolling By Invitation

• 1 other identifier: STUDY00002808-2022
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes

Keywords

Food as Medicine; Medically tailored meals; Chronic Disease; Food Insecurity; Food Home Delivery; Implementation Science

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1C (HbA1c)

  Finger stick point-of-care portable device.

  Baseline to 6 months

Secondary Outcomes (13)

• Change in Hemoglobin A1C

  Baseline to 9 &12 months, 6 months to 12 months.

• Program meal consumption

  6 months, 12 months

• Diet quality as assessed by NHANES DSQ

  6 months, 12 months

• Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale

  6 months, 12 months

• Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8)

  6 months, 12 months

Study Arms (3)

Waitlisted control

OTHER

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

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

"Daily Warm" MTM in-person delivery

EXPERIMENTAL

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

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

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.

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

Interventions

Waitlist BEHAVIORAL

Phase 1 (6 months) • Educational materials on such topics as healthy eating for diabetes.

Waitlisted control

Medically tailored meals - Daily delivery with human interaction 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.

"Daily Warm" MTM in-person delivery

Medically tailored meals - Weekly delivery with no human interaction 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.

"Weekly Frozen" MTM drop shipment

Medically tailored meals - Standard MOWCTX delivery with human interaction 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; "Weekly Frozen" MTM drop shipment; Waitlisted control

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas at Austin: lead
• Meals on Wheels Central Texas: collaborator

Study Sites (2)

Meals on Wheels Central Texas

Austin, Texas, 78702, United States

Location

CommUnityCare Health Centers (all Austin clinics)

Austin, Texas, 78741, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Chronic Disease

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Maninder K Kahlon, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research staff responsible for data collection at the sites are blinded to the arm allocation of the participant. At follow-up time points, however, a set of questions is asked that are different for each of the three arms on food intake and preferences, and for arm 2, for the experience of delivery. To minimize influence of unblinding, we will actively cross-assign research staff to different locations for follow-up visits.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Community-based trial randomized on a 2:3:3 ratio

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 20, 2020
• Study Start: December 5, 2022
• Primary Completion: May 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)