Feeding America Intervention Trial for Health--Diabetes Mellitus (FAITH-DM)
14 de mayo de 2020 actualizado por: University of California, San Francisco
The Feeding America Intervention Trial for Health-Diabetes Mellitus (FAITH-DM) is a randomized, controlled study of the implementation of a diabetes intervention in food pantry settings.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
For adults with diabetes mellitus, diabetes self-management education (DSME) is critical to achieving long-term control of blood sugar levels (glycemic control) and preventing diabetes-associated complications.
This education is often difficult to access for highly vulnerable and marginalized adults in the United States.
Furthermore, foods for a diabetic diet are often out of reach for food insecure households.
The purpose of this study is to determine the extent to which food banks and food pantries can help reach this population with effective DSME, food, and access to primary health care.
The investigators' primary outcome of interest is HbA1c improvement in the intervention group compared to a wait-listed control group of food pantry clients living with uncontrolled type 2 diabetes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
568
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Oakland, California, Estados Unidos, 94614
- Alameda County Community Food Bank
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San Francisco, California, Estados Unidos, 94143
- University of California San Francisco
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Michigan
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Detroit, Michigan, Estados Unidos, 48207
- Gleaners Community Food Bank of Southeastern Michigan
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Texas
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Houston, Texas, Estados Unidos, 77029
- Houston Food Bank
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Food pantry client at one of three participating food banks: Alameda County Community Food Bank (Oakland, CA), Gleaners Community Food Bank of Southeastern Michigan (Detroit, MI), Houston Food Bank, (Houston, TX)
- Type II diabetes mellitus with HbA1c ≥ 7.5% using food bank point-of-care testing
- Reliable mode of contact (either phone or address)
- English or Spanish verbal fluency
- 18 years of age or older
- Intent to remain in the study area for at least the next 12 months
- Willingness to participate in intervention
Exclusion Criteria:
- Type 1 diabetes
- Pregnant or less than 6 weeks post-partum
- Cognitively impaired: dementia, mental illness, or active substance abuse severe enough to interfere with administration of the survey or participation in the intervention
- Household member already enrolled in the study
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Immediate Intervention
Participants randomized to the Intervention Arm will immediately begin a four-component intervention.
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Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists.
Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Education materials drawn from evidence-based practice and adapted from existing diabetes education curricula to be flexible to individual, community, and site variations.
The Immediate Intervention Arm receives more robust diabetes self-management education (with group education visits) than the Waitlist Control Arm.
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Comparador activo: Waitlist Control
Participants randomized to the Waitlist Control arm will receive no intervention for six months, after which time they will begin a modified, four-component intervention.
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Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
Referral to a local primary care provider, if none currently exists.
Coordination of care with primary care provider.
Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
Education materials drawn from evidence-based practice and adapted from existing diabetes education curricula to be flexible to individual, community, and site variations.
The Immediate Intervention Arm receives more robust diabetes self-management education (with group education visits) than the Waitlist Control Arm.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline HbA1c at 6 Months
Periodo de tiempo: 6 months
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Point-of-care HbA1c testing with the PTS Diagnostics A1CNow®+ System
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6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline Dietary Intake
Periodo de tiempo: 6 months and 12 months
|
Brief fruit & vegetable dietary screener
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6 months and 12 months
|
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Change from Baseline Health Care Utilization
Periodo de tiempo: 6 months and 12 months
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Communication with primary care provider requesting dates of service, service levels, and diagnosis codes
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6 months and 12 months
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Change from Baseline Diabetes Distress
Periodo de tiempo: 6 months and 12 months
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Self-reported distress as assessed by the 2-item emotional burden sub-score of the Diabetes Distress Scale
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6 months and 12 months
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Change from Baseline Hypoglycemic events
Periodo de tiempo: 6 months and 12 months
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Self-reported hypoglycemic events over the previous 4 weeks, both any events and number of events, and self-reported severe hypoglycemic episodes, both any events and number of events
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6 months and 12 months
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Change from Baseline Depressive symptoms
Periodo de tiempo: 6 months and 12 months
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PHQ-8 (a subset of PHQ-9 scores without assessment of suicidality)
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6 months and 12 months
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Change from Baseline Medication Adherence
Periodo de tiempo: 6 months and 12 months
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Morisky Medication Adherence Scale (4 items)
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6 months and 12 months
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Food vs medicine trade-offs
Periodo de tiempo: 6 months and 12 months
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Three self-reported questions
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6 months and 12 months
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Change from Baseline Food security status
Periodo de tiempo: 6 months and 12 months
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6-item version of the USDA's Core Food Security Survey Module
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6 months and 12 months
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Change from Baseline Food stability
Periodo de tiempo: 6 months and 12 months
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Two items assessing adequacy of food resources to last the entire month
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6 months and 12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from Baseline Diabetes Self-Efficacy
Periodo de tiempo: 6 months and 12 months
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8-item scale of diabetes-specific self-efficacy
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6 months and 12 months
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Change from Baseline Diabetes Self-Care
Periodo de tiempo: 6 months and 12 months
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Self-reported assessment of 5 self-care behaviors: medications, exercise, diet, blood sugar monitoring, and foot care
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6 months and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Hilary K Seligman, MD MAS, University of California, San Francisco
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Seligman HK, Levi R, Ridberg R, Smith M, Hills N, Waxman E. Impact of Enhanced Food Pantry Services on Food Security among Adults with Diabetes Using a Crossover Study Design. Curr Dev Nutr. 2022 Feb 10;6(4):nzac021. doi: 10.1093/cdn/nzac021. eCollection 2022 Apr.
- Smith M, Rosenmoss S, Seligman HK. Point-of-Care Hemoglobin A1C Testing System in Community Settings: Challenges, Opportunities, and Measurement Characteristics. Prog Community Health Partnersh. 2020;14(3):327-335. doi: 10.1353/cpr.2020.0038.
- Seligman HK, Smith M, Rosenmoss S, Marshall MB, Waxman E. Comprehensive Diabetes Self-Management Support From Food Banks: A Randomized Controlled Trial. Am J Public Health. 2018 Sep;108(9):1227-1234. doi: 10.2105/AJPH.2018.304528. Epub 2018 Jul 19.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de octubre de 2015
Finalización primaria (Actual)
31 de octubre de 2017
Finalización del estudio (Actual)
31 de octubre de 2017
Fechas de registro del estudio
Enviado por primera vez
2 de octubre de 2015
Primero enviado que cumplió con los criterios de control de calidad
5 de octubre de 2015
Publicado por primera vez (Estimar)
6 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de mayo de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
14 de mayo de 2020
Última verificación
1 de mayo de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- A125548
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .