FreshStart for Health Study (FS4H)
8 de septiembre de 2026 actualizado por: Cornell University
FreshStart for Health: Produce Prescription to Promote Health Behaviors and Food Security.
The goal of this study is to test whether a produce prescription program (FS4H) influences health behaviors and food security.
FS4H engages a total of 4 cohorts to receive fresh local produce and nutrition lessons.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
This project aims to evaluate the effectiveness and implementation of a produce prescription (PRx) program on health behaviors and food security.
The PRx program being evaluated, known as FreshStart for Health (FS4H), offers participants nutrition education lessons and access to fresh local produce (fruits and vegetables) across multiple cohorts, each with varying durations (8, 12, 18, or 24 weeks).
FS4H is administered by Buffalo Go Green, serving eligible Kaleida Health employees in Buffalo, New York.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
200
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
-
-
New York
-
Buffalo, New York, Estados Unidos, 14209
- Kaledia Health
-
Buffalo, New York, Estados Unidos, 14211
- Buffalo Go Green
-
Buffalo, New York, Estados Unidos, 14215
- Nutrition Education: Holistic Wellness & Agricultural Education Campus, Buffalo Go Green
-
Buffalo, New York, Estados Unidos, 14222
- Nutrition Education (Teaching Kitchen Live/Recorded): Buffalo State University, Caudell Hall
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Age 18-65 years.
- Be enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having one of the following:
- Prediabetes.
- Diabetes.
- Prehypertension.
- Hypertension.
- Obesity.
- Food Insecurity.
- Financial insecurity.
Exclusion Criteria:
- Not being enrolled in Kaleida's Highmark Blue Cross Blue Shield health plan.
- Having no chronic health condition.
- Being food secure.
- Having financial stability.
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: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Weekly produce prescriptions for eight (8) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 8 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
|
Experimental: Weekly produce prescriptions for twelve (12) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 12 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
|
Experimental: Weekly produce prescriptions for eighteen (18) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 18 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
|
Experimental: Weekly produce prescriptions for twenty-four (24) weeks.
At random (using a random number generator), participants will be assigned to join a cohort to receive produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants assigned under this arm will receive produce prescriptions up to 24 weeks total.
|
At random (using a random number generator), participants will be assigned to join a cohort to receive a weekly produce prescription for 8, 12, 18, or 24 weeks.
Produce prescriptions can be picked up at a specified location or they can be delivered to participants' home.
Participants will attend eight (8), one-hour nutrition education classes.
Nutrition education classes will be held primary in-person although a virtual (Zoom) option will be made available if necessary.
The classes will be recorded.
Nutrition education classes range in topics from eating healthy on a budget to cooking and recipe demonstrations, which entail attending a lecture portion that is combined with hands-on activities during each session.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Fruit and vegetable intake
Periodo de tiempo: Up to 24 weeks.
|
Participants will complete the short form of the Dietary Screener Questionnaire (10 items) at baseline and post-intervention.
|
Up to 24 weeks.
|
|
Food security
Periodo de tiempo: Up to 24 weeks.
|
Participants will complete the 6-item USDA Household Food Security Module to assess food security status at baseline and post-intervention.
|
Up to 24 weeks.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Physical and mental health outcomes
Periodo de tiempo: Up to 24 weeks.
|
Participants will complete a set of validated scales at baseline and after completion of nutrition education classes.
|
Up to 24 weeks.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Roger Figueroa, Ph.D., M.P.H., M.Sc., Cornell University
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)
6 de julio de 2026
Finalización primaria (Estimado)
20 de diciembre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
13 de enero de 2026
Primero enviado que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Publicado por primera vez (Actual)
11 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
8 de septiembre de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB0149718
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .