Clinical trial NCT04277117: Meals for Me: Drop Shipment Versus Personally-delivered Meals for Diabetes Management
Official title: Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Diabetes
Keywords: Food as Medicine
Medically tailored meals
Chronic Disease
Food Insecurity
Food Home Delivery
Implementation Science
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Meals on Wheels Central Texas
First posted: 2020-02-20
Enrollment: 320
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Community-based trial randomized on a 2:3:3 ratio
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Hemoglobin A1C (HbA1c)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in Hemoglobin A1C
timeFrame: Baseline to 9 &12 months, 6 months to 12 months.
measure: Program meal consumption
timeFrame: 6 months, 12 months
measure: Diet quality as assessed by NHANES DSQ
timeFrame: 6 months, 12 months
measure: Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale
timeFrame: 6 months, 12 months
measure: Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8)
timeFrame: 6 months, 12 months
measure: Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
timeFrame: 6 months
measure: Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
timeFrame: 6 months, 12 months
measure: Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form
timeFrame: 6 months, 12 months
measure: Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12)
timeFrame: 6 months, 12 months
measure: Healthcare delay due to cost
timeFrame: 6 months, 12 months
measure: Emergency room visits
timeFrame: 6 months, 12 months
measure: Food-basic needs trade-offs (3 items)
timeFrame: 6 months, 12 months
measure: Medication underuse due to cost (2 items)
timeFrame: 6 months, 12 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: Meals on Wheels Central Texas
state: Texas
city: Austin
country: United States
facility: CommUnityCare Health Centers (all Austin clinics)
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Maninder K Kahlon, PhD
role: PRINCIPAL_INVESTIGATOR
References: