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

Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: Waitlist; Behavioral: Medically tailored meals - Weekly delivery with no human interaction; Behavioral: Medically tailored meals - Standard MOWCTX delivery with human interaction; Behavioral: Medically tailored meals - Daily delivery with human interaction

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78702
      • Meals on Wheels Central Texas
    • Austin, Texas, United States, 78741
      • CommUnityCare Health Centers (all Austin clinics)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Behavioral: Waitlist; Phase 1 (6 months) • Educational materials on such topics as healthy eating for diabetes.; 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).
Experimental: "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	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).; 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.
Experimental: "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.	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.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1C (HbA1c)	Finger stick point-of-care portable device.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1C	Finger stick point-of-care portable device.	Baseline to 9 &12 months, 6 months to 12 months.
Program meal consumption	For frozen and warm meals, self-report on what was actually consumed (customized survey)	6 months, 12 months
Diet quality as assessed by NHANES DSQ	Self-report of food consumption patterns	6 months, 12 months
Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale	Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.	6 months, 12 months
Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8)	Respondents answer to eight questions that reflect the DSM-IV diagnosis criteria of depressive disorders. These questions ask how often in the past 2 weeks the respondent had experienced a particular depressive symptom. Each answer is scored from 0 to 3 and then summed. Total scores go from 0 and 24 points, with higher scores indicating greater depressive symptoms.	6 months, 12 months
Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)	Investigators will use the Generalized Anxiety Disorder Scale (GAD-7) to measure anxiety. Scored from 0-3, and a score of 0 indicates lower levels of anxiety while a score of 3 indicates higher levels of anxiety.	6 months
Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item	Respondents are asked to score their level of confidence (scale from 1, not at all confident, to 10, totally confident) at the present time in doing tasks related to diabetes management (e.g., diet behavior, physical activity, measuring blood glycemia and others). Higher scores indicate higher self-efficacy.	6 months, 12 months
Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form	Self-reported with a 30-day lookback period. The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Higher scores indicate greater food insecurity.	6 months, 12 months
Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12)	Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.	6 months, 12 months
Healthcare delay due to cost	Self-report of delaying healthcare due to cost. 1 item.	6 months, 12 months
Emergency room visits	Self-report of going to a hospital emergency room.	6 months, 12 months
Food-basic needs trade-offs (3 items)	Self-report of trading off paying for food vs. paying for medicine or medical care, for utilities, and for housing	6 months, 12 months
Medication underuse due to cost (2 items)	Self-report of not acquiring a prescribed medication or took reduce dosage due to cost.	6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: Meals on Wheels Central Texas
• Investigators: Principal Investigator: Maninder K Kahlon, PhD, University of Texas at Austin

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2022
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 31, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (Actual): February 20, 2020

Study Record Updates

• Last Update Posted (Estimated): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Implementation Science; Chronic Disease; Food Insecurity; Food as Medicine; Medically tailored meals; Food Home Delivery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: STUDY00002808-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No