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| Name | Class |
|---|---|
| Meals on Wheels Central Texas | OTHER |
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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.
This study aims to:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waitlisted control | Other | Phase 1 (6 months, months 1-6):
Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week |
|
| "Daily Warm" MTM in-person delivery | Experimental | Phase 1 (6 months, months 1-6):
Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week |
|
| "Weekly Frozen" MTM drop shipment | Experimental | Phase 1 (6 months, months 1-6):
Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Waitlist | Behavioral | Phase 1 (6 months) • Educational materials on such topics as healthy eating for diabetes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1C (HbA1c) | Finger stick point-of-care portable device. | Baseline to 6 months |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maninder K Kahlon, PhD | University of Texas at Austin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meals on Wheels Central Texas | Austin | Texas | 78702 | United States | ||
| CommUnityCare Health Centers (all Austin clinics) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 21, 2023 |
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Community-based trial randomized on a 2:3:3 ratio
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Research staff responsible for data collection at the sites are blinded to the arm allocation of the participant. At follow-up time points, however, a set of questions is asked that are different for each of the three arms on food intake and preferences, and for arm 2, for the experience of delivery. To minimize influence of unblinding, we will actively cross-assign research staff to different locations for follow-up visits.
| Medically tailored meals - Daily delivery with human interaction | Behavioral | Phase 1 (6 months)
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| Medically tailored meals - Weekly delivery with no human interaction | Behavioral | Phase 1 (6 months)
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| Medically tailored meals - Standard MOWCTX delivery with human interaction | Behavioral | Phase 2 (6 months)
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| 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 |
| Austin |
| Texas |
| 78741 |
| United States |
| Jul 24, 2023 |
| Prot_SAP_001.pdf |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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