Meals for Me: Drop Shipment Versus Personally-delivered Meals for Diabetes Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Waitlist, Medically tailored meals - Daily delivery with human interaction, Medically tailored meals - Weekly delivery with no human interaction, Medically tailored meals - Standard MOWCTX delivery with human interaction.
- Who it may be relevant to
- Registry conditions: Diabetes. Basic parameters: 55 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.
Overview
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.
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 eve - 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 particip - 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 so
Primary outcome measures
- Change in Hemoglobin A1C (HbA1c) [Time frame: Baseline to 6 months]
Secondary outcome measures (12)
- Change in Hemoglobin A1C [Time frame: Baseline to 9 &12 months, 6 months to 12 months.]
- Program meal consumption [Time frame: 6 months, 12 months]
- Diet quality as assessed by NHANES DSQ [Time frame: 6 months, 12 months]
- Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale [Time frame: 6 months, 12 months]
- Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8) [Time frame: 6 months, 12 months]
- Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7) [Time frame: 6 months]
- Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item [Time frame: 6 months, 12 months]
- Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form [Time frame: 6 months, 12 months]
- Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12) [Time frame: 6 months, 12 months]
- Healthcare delay due to cost [Time frame: 6 months, 12 months]
- Emergency room visits [Time frame: 6 months, 12 months]
- Food-basic needs trade-offs (3 items) [Time frame: 6 months, 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Health services research
Study locations
United States · 2 centers
- Meals on Wheels Central Texas — Austin
- CommUnityCare Health Centers (all Austin clinics) — Austin
Identifiers
NCT: NCT04277117 · STUDY00002808-2022