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Refeições para mim: controlando o diabetes em casa

17 de setembro de 2026 atualizado por: Maninder Kahlon, University of Texas at Austin

Entrega em domicílio de refeições sob medida para melhorar o controle do diabetes

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.

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

320

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Texas
      • Austin, Texas, Estados Unidos, 78702
        • Meals on Wheels Central Texas
      • Austin, Texas, Estados Unidos, 78741
        • CommUnityCare Health Centers (all Austin clinics)

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

55 anos a 90 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Waitlisted control

Phase 1 (6 months, months 1-6):

  • Educational materials on healthy eating for diabetes
  • No meal delivery

Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week
Comportamental: Waitlist

Phase 1 (6 months)

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

Comportamental: 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 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).
Experimental: "Daily Warm" MTM in-person delivery

Phase 1 (6 months, months 1-6):

  • Educational materials on healthy eating for diabetes
  • 10 medically-tailored meals (MTM) per week, delivered 3-5x per week Mon-Fri
  • Each delivery day, 1 hot and 1 frozen + snack delivered to the participant's home by trained volunteers and/or paid delivery drivers who provide human interaction. 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.

Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week
Comportamental: 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 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).
Comportamental: 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 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.
Experimental: "Weekly Frozen" MTM drop shipment

Phase 1 (6 months, months 1-6):

  • Educational materials on healthy eating for diabetes
  • 10 medically-tailored meals (MTM) delivered once a week
  • Each week all meals are frozen.
  • Meals are shipped to the participant's home with no human interaction

Phase 2 (6 months, months 7-12): Standard MOWCTX home meal delivery: 5 meals a week, delivered daily 2 to 4X a week.
Comportamental: 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 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).
Comportamental: 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 participant's home. No human engagement.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Hemoglobin A1C (HbA1c)
Prazo: Baseline to 6 months

Finger stick point-of-care portable device.
Baseline to 6 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Hemoglobin A1C
Prazo: Baseline to 9 &12 months, 6 months to 12 months.

Finger stick point-of-care portable device.
Baseline to 9 &12 months, 6 months to 12 months.
Program meal consumption
Prazo: 6 months, 12 months

For frozen and warm meals, self-report on what was actually consumed (customized survey)
6 months, 12 months
Diet quality as assessed by NHANES DSQ
Prazo: 6 months, 12 months

Self-report of food consumption patterns
6 months, 12 months
Loneliness as assessed by scores on the 3-item UCLA Loneliness Scale
Prazo: 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.
6 months, 12 months
Depressive symptoms as assessed by scores on the the 8-item Depression Health Questionnaire (PHQ-8)
Prazo: 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 months, 12 months
Anxiety symptoms as assessed by the 7-item Generalized Anxiety Disorder Scale (GAD-7)
Prazo: 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.
6 months
Diabetes Self-Efficacy as assessed by scores on the Stanford Self-Efficacy for Diabetes Scale 8-item
Prazo: 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.
6 months, 12 months
Food security status as assessed by the USDA Food Security Survey Module: Six-Item Short Form
Prazo: 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.
6 months, 12 months
Health Status and Quality of Life as assessed by scores on Short-form 12-item (SF-12)
Prazo: 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.
6 months, 12 months
Healthcare delay due to cost
Prazo: 6 months, 12 months

Self-report of delaying healthcare due to cost. 1 item.
6 months, 12 months
Emergency room visits
Prazo: 6 months, 12 months

Self-report of going to a hospital emergency room.
6 months, 12 months
Food-basic needs trade-offs (3 items)
Prazo: 6 months, 12 months

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)
Prazo: 6 months, 12 months

Self-report of not acquiring a prescribed medication or took reduce dosage due to cost.
6 months, 12 months

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Texas at Austin

Colaboradores

Meals on Wheels Central Texas

Investigadores

  • Investigador principal: Maninder K Kahlon, PhD, University of Texas at Austin

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de dezembro de 2022

Conclusão Primária (Estimado)

30 de novembro de 2026

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

31 de janeiro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de fevereiro de 2020

Primeira postagem (Real)

20 de fevereiro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

21 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • STUDY00002808-2022

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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