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Living Hungry Healthy Foods Prescription Program

27 de outubro de 2020 atualizado por: Dariush Mozaffarian, Tufts University
This study is a pre/post, pilot evaluation of the 4-month, Living Hungry program for food-insecure patients with uncontrolled diabetes. The program provides free produce, whole grains and legumes to participants and their household every-other week, in addition, to nutrition education and glucose monitoring devices. The study is analyzing diabetes management indicators, including HbA1c, dietary quality, food insecurity, and medication adherence, plus health care utilization.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

The Living Hungry Collaborative, in partnership with the South Florida Hunger Coalition, previously operated a pilot program, Fresh Food Farmacy, staged from June 1, 2018, to September 29, 2018. The program consisted of nine Eat Well Pop-Up Pantry events at the My Clinic in Jupiter, Florida, serving 104 patients and feeding approximately 300 people including their families. Each set of groceries contained two weeks' worth of "medically tailored" groceries for diabetic-friendly meals for food-insecure patients diagnosed with diabetes or prediabetes. All clients involved in the intervention were referred by staff at the same four clinics that will participate in this study: My Clinic, C.L. Brumback Clinic in Jupiter, Jupiter Medical Center, and FoundCare. The Living Hungry Collaborative has an ongoing program to further evolve and test the "Fresh Food Farmacy", renamed as the Healthy Food Prescription Program intervention in Palm Beach County, for food-insecure, diabetic patients.

In addition to receiving diabetic appropriate groceries at the former Fresh Food Farmacy events, clients will be engaged in diabetes education classes led by volunteer doctors and nurses, cooking demonstrations, shared meals, 1:1 and group coaching by nutritionists and dietitians on best choices from a menu for diabetics, and tasting new recipes with produce from the pop-up event. The pilot program allowed Living Hungry to fine-tune the patient referral process, distribution logistics, and establish strong partnerships required for the next phase of the program. However, gaps exist to understand the extent to which the program design is improving the health of the participating diabetic patients.

Living Hungry will partner with Tufts University to conduct an evaluation of this existing program on key health outcomes that concern the partner clinics, specifically: biomarkers including Hemoglobin A1C, BMI, blood pressure, lipid profile, health care utilization including medication use, hospitalizations, emergency department visits, and health care costs, plus dietary quality, food insecurity, medication use, and quality of life indicators. The study is a pilot evaluation, implementing a quasi-experimental, pre/post study design.

The Living Hungry Healthy Foods Prescription Program is a community-based program that will be available to individuals whether or not they participate in the evaluation by Tufts University. This program is using the same referral and data collections procedures as the pilot, which include having physicians at the partner clinics refer patients with HbA1C levels greater than 8.0 mmol/mol and who are food insecure to Living Hungry to participate in the program. In addition, Living Hungry will again collect data on HbA1c, BMI, blood pressure, lipid profiles, and distribute a survey to participants.

Tipo de estudo

Intervencional

Inscrição (Real)

35

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

    • Florida
      • West Palm Beach, Florida, Estados Unidos, 33401
        • Living Hungry

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

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Referred patient from one of four medical partners: My Clinic, C.L. Brumback Clinic, FoundCare and Jupiter Medical Center and has been a patient for at least one-year.
  2. Diabetic with A1C over 8.0
  3. Adults 18 years of age or older
  4. Food-insecure

Exclusion Criteria:

  1. Referred patients with HbA1c levels below 8.0 mmol/mol
  2. Minors
  3. Adults with severe mental illness who cannot provide informed consent, unless they have present a lawful caregiver or power of attorney.
  4. Anyone who does not plan on staying in West Palm Beach for the next 4 months.
  5. Pregnant women (can still receive services through the program but will not be included in the analysis)

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: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Healthy Food Prescription
Participants receive services through the Living Hungry program for food insecure diabetic patients.
Participants will receive diabetic appropriate groceries, diabetes education classes led by volunteer doctors and nurses, cooking demonstrations, shared meals, 1:1 and group coaching by dietitians.
Outros nomes:
  • medically tailored food

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in Hemoglobin A1c
Prazo: pre/post change in HbA1c in participants from baseline to completion of the program at 4 months
will be measured by blood draws at first and last program event
pre/post change in HbA1c in participants from baseline to completion of the program at 4 months

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in frequency of hospitalizations
Prazo: pre/post change in hospitalizations in participants from baseline to one month after completion of the program
will be measured through surveys and data from electronic medical records
pre/post change in hospitalizations in participants from baseline to one month after completion of the program
Change in frequency of emergency department admissions
Prazo: pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
will be measured through surveys and data from electronic medical records
pre/post change in emergency department admissions in participants from baseline to one month after completion of the program
Change in total health care costs
Prazo: pre/post change in total health care costs in participants from baseline to one month after completion of the program
will be measured through data from hospital records
pre/post change in total health care costs in participants from baseline to one month after completion of the program
Change in food insecurity
Prazo: pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
Food insecurity will be measured using the USDA 9-question food insecurity screener
pre/post change in food insecurity in participants from baseline to completion of the program at 4 months
Change in daily servings of fruits and vegetables
Prazo: pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
pre/post change in daily servings of fruits and vegetables in participants from baseline to completion of the program at 4 months
Change in daily servings of whole grains
Prazo: pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool
pre/post change in daily servings of whole grains in participants from baseline to completion of the program at 4 months
Change in daily servings of lean proteins
Prazo: pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: nuts, seeds, legumes, poultry, and fish.
pre/post change in daily servings of lean proteins in participants from baseline to completion of the program at 4 months
Change in daily servings of sugary snacks and drinks
Prazo: pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
Will be assessed through a food frequency questionnaire modeled off the USDA FINI assessment tool and includes: sugar sweetened beverages, pastries, cookies, cakes, candy, and other sweets
pre/post change in daily servings of sugary snacks and drinks in participants from baseline to completion of the program at 4 months
Change in medication adherence
Prazo: pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
Measured as a composite score that will be assessed through a survey. Components include: frequency of sacrificing medication purchases for other household needs (such as food, utilities) and change in medication use.
pre/post change in medication adherence in participants from baseline to completion of the program at 4 months
Change in adhering to recommended diabetes management plan
Prazo: pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
Measured as a composite scale that will be assessed through a survey. Components include frequency in which participants followed the recommendations of their physicians to manage their diabetes.
pre/post change in in adhering to recommended diabetes management in participants from baseline to completion of the program at 4 months
Change in blood LDL level
Prazo: pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
measured at first and last program event through a blood draw
pre/post change in systolic blood LDL levels in participants from baseline to completion of the program at 4 months
Change in systolic blood pressure
Prazo: pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
measured at first and last program event
pre/post change in systolic blood pressure in participants from baseline to completion of the program at 4 months
Change in diastolic blood pressure
Prazo: pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months
measured at first and last program event
pre/post change in diastolic blood pressure in participants from baseline to completion of the program at 4 months

Colaboradores e Investigadores

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

Patrocinador

Investigadores

  • Investigador principal: Dariush Mozaffarian, MD, DrPH, Tufts University Friedman School of Nutrition Science and Policy

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)

14 de dezembro de 2019

Conclusão Primária (Real)

25 de julho de 2020

Conclusão do estudo (Real)

13 de outubro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

16 de dezembro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de dezembro de 2019

Primeira postagem (Real)

19 de dezembro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

28 de outubro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

27 de outubro de 2020

Última verificação

1 de outubro de 2020

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • 13491

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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