Meals for Me: Drop Shipment Versus Personally-delivered Meals for Diabetes Management
NCT04277117 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320
Last updated 2025-03-26
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
Interventions
- BEHAVIORAL
-
Waitlist
Phase 1 (6 months) • Educational materials on such topics as healthy eating for diabetes.
- 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.
- 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).
Sponsors & Collaborators
-
Meals on Wheels Central Texas
collaborator OTHER -
University of Texas at Austin
lead OTHER
Principal Investigators
-
Maninder K Kahlon, PhD · University of Texas at Austin
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 55 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-12-05
- Primary Completion
- 2025-05-01
- Completion
- 2026-08-01
Countries
- United States
Study Locations
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