Meals for Me: Drop Shipment Versus Personally-delivered Meals for Diabetes Management
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: 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.
- Кому может быть актуально
- Состояния в реестре: Diabetes. Базовые параметры: 55 лет — 90 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Meals for Me: Drop Shipment Versus Personally Delivered Medically Tailored Meals for Patients With Unmanaged Diabetes.
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Waitlist
Phase 1 (6 months) • Educational materials on such topics as healthy eating for diabetes. - Поведенческое 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 - Поведенческое 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 - Поведенческое 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
Первичные конечные точки
- Change in Hemoglobin A1C (HbA1c) [Срок оценки: Baseline to 6 months]
Вторичные конечные точки (12)
- Change in Hemoglobin A1C [Срок оценки: Baseline to 9 &12 months, 6 months to 12 months.]
- Program meal consumption [Срок оценки: 6 months, 12 months]
- Diet quality as assessed by NHANES DSQ [Срок оценки: 6 months, 12 months]
- Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale [Срок оценки: 6 months, 12 months]
- Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8) [Срок оценки: 6 months, 12 months]
- Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7) [Срок оценки: 6 months]
- Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item [Срок оценки: 6 months, 12 months]
- Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form [Срок оценки: 6 months, 12 months]
- Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12) [Срок оценки: 6 months, 12 months]
- Healthcare delay due to cost [Срок оценки: 6 months, 12 months]
- Emergency room visits [Срок оценки: 6 months, 12 months]
- Food-basic needs trade-offs (3 items) [Срок оценки: 6 months, 12 months]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 2 центра
- Meals on Wheels Central Texas — Austin
- CommUnityCare Health Centers (all Austin clinics) — Austin
Идентификаторы
NCT: NCT04277117 · STUDY00002808-2022