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Enrolling by Invitation

NCT Number: NCT04277117

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

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.

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Key information

Conditions

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

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CommUnityCare Health Centers (all Austin clinics), Austin, Texas, United States

Loading trial locations.

About this study

This study aims to:

  • Assess the impact of medically-tailored meals program on diabetes management and mental health in comparison to usual care without such program.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Waitlist

Behavioral

Phase 1 (6 months)

  • Educational materials on such topics as healthy eating for diabetes.

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.

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.

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).

Primary outcomes

  1. Change in Hemoglobin A1C (HbA1c)

    Time frame: Baseline to 6 months

    Finger stick point-of-care portable device.

Secondary outcomes

  1. Change in Hemoglobin A1C

    Time frame: Baseline to 9 &12 months, 6 months to 12 months.

    Finger stick point-of-care portable device.

  2. Program meal consumption

    Time frame: 6 months, 12 months

    For frozen and warm meals, self-report on what was actually consumed (customized survey)

  3. Diet quality as assessed by NHANES DSQ

    Time frame: 6 months, 12 months

    Self-report of food consumption patterns

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

    Time frame: 6 months, 12 months

    Respondents rate each item as 'Never' , 'Rarely', 'Sometimes' or 'Often'. Scores range from 3 to 9. Higher numbers imply greater loneliness.

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

    Time frame: 6 months, 12 months

    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. Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)

    Time frame: 6 months

    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.

  7. Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item

    Time frame: 6 months, 12 months

    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.

  8. Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form

    Time frame: 6 months, 12 months

    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.

  9. Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12)

    Time frame: 6 months, 12 months

    Measures physical and mental health status. Summary scores range from 0-100, with higher scores indicating a better self-reported level of health.

  10. Healthcare delay due to cost

    Time frame: 6 months, 12 months

    Self-report of delaying healthcare due to cost. 1 item.

  11. Emergency room visits

    Time frame: 6 months, 12 months

    Self-report of going to a hospital emergency room.

  12. Food-basic needs trade-offs (3 items)

    Time frame: 6 months, 12 months

    Self-report of trading off paying for food vs. paying for medicine or medical care, for utilities, and for housing

  13. Medication underuse due to cost (2 items)

    Time frame: 6 months, 12 months

    Self-report of not acquiring a prescribed medication or took reduce dosage due to cost.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Collaborators

  • Meals on Wheels Central Texas

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Feb 20, 2020
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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