Nutrition Intervention Optimization to Better Utilize Resources and Support Health (NOURISH)
14 de julio de 2026 actualizado por: Tufts University
Optimizing Interventions to Improve Nutrition Security and Reduce Diabetes Risk Among Food Pantry Clients
Not having enough food for each person in a household, also called food insecurity, makes it hard to eat a nutritious diet, maintain a healthy weight, and manage diabetes risk.
Food banks and pantries provide direct food assistance that can mitigate food insecurity among people with lower income, however, people that utilize these organizations face time, resource, and physical constraints that limit their ability to consistently select and cook healthier meals and the organizations face budget constraints that limit their bandwidth for implementing nutrition programs.
This research will test four innovative nutrition programs (nutritious prepared meals, medically tailored groceries in the form of meal kits, culinary medicine, motivational text messages) to identify which are the most effective for supporting healthy eating and food security and the most cost effective for organizations to implement, as an effort to reduce diabetes risk, improve diabetes self-management, and diminish health disparities.
Descripción general del estudio
Estado
Aún no reclutando
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
400
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.
Estudio Contacto
- Nombre: NICHE Lab Team
- Número de teléfono: (469) 240-9112
- Correo electrónico: niche@tufts.edu
Ubicaciones de estudio
-
-
Texas
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Dallas, Texas, Estados Unidos, 75236
- Crossroads Community Services
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Contacto:
- NICHE Lab Team
- Número de teléfono: (469) 240-9112
- Correo electrónico: niche@tufts.edu
-
-
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
No
Descripción
Inclusion Criteria:
- Aged 18+,
- Body mass index (BMI)≥ 25;
- Access to a device with SMS and MMS (picture) text and Wi-Fi capabilities (e.g., phone, tablet, computer) and willingness to use the device regularly during the study;
- Willingness to complete four in-person data collection appointments;
- Willing and able to consent.
Exclusion Criteria:
- Presence of a condition or dietary restriction precluding eating study meals or weight loss (e.g., condition requiring liquid diet, pregnancy);
- Another member of the household participating;
- Planning to move within the next 12 months;
- Unwilling to participate.
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: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Condition 1: Pantry, MTG, No-prep meals, Culinary classes, and SMS
Pantry provisions, meal kits, no-prep meals, culinary nutrition classes, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Experimental: Condition 2: Pantry, MTG, No-prep meals, and Culinary classes
Pantry provisions, meal kits, no-prep meals, and culinary nutrition classes
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Experimental: Condition 3: Pantry, MTG, No-prep meals, and SMS
Pantry provisions, meal kits, no-prep meals, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Experimental: Condition 4: Pantry, MTG, and No-prep meals
Pantry provisions, meal kits, and no-prep meals
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
|
|
Experimental: Condition 5: Pantry, MTG, Culinary classes, and SMS
Pantry provisions, meal kits, culinary nutrition classes, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Experimental: Condition 6: Pantry, MTG, and Culinary classes
Pantry provisions, meal kits, and culinary nutrition classes
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Experimental: Condition 7: Pantry, MTG, and SMS
Pantry provisions, meal kits, and text messages
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Experimental: Condition 8: Pantry and MTG
Pantry provisions and meal kits
|
Meal kits combine ingredients (e.g., chicken, tomatillo salsa verde, peppers, sweet potatoes) in a bag with a recipe that instructs how to make a healthier meal (e.g., Chicken Tomatillo Salsa Verde with Peppers and Sweet Potatoes).
Otros nombres:
|
|
Experimental: Condition 9: Pantry, No-prep meals, Culinary classes, and SMS
Pantry provisions, no-prep meals, culinary nutrition classes and text messages
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Experimental: Condition 10: Pantry, No-prep meals, and Culinary classes
Pantry provisions, no-prep meals, and culinary nutrition classes
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Experimental: Condition 11: Pantry, No-prep meals, and SMS
Pantry provisions, no-prep meals, and text messages
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Experimental: Condition 12: Pantry and No-prep meals
Pantry provisions and no-prep meals
|
The meals were created to meet nutrition standards for people with or at-risk for cardiometabolic diseases.
Each entree has at least one serving of proteins, whole grains, and two vegetables.
Entrees are low in sodium and sugar and meet carbohydrate recommendations for people with diabetes.
Otros nombres:
|
|
Experimental: Condition 13: Pantry, Culinary classes, and SMS
Pantry provisions, culinary nutrition classes, and text messages
|
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes.
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Experimental: Condition 14: Pantry and Culinary classes
Pantry provisions and culinary nutrition classes
|
Participants randomly assigned to receive culinary nutrition classes will receive six-weeks of hybrid instruction from the Health Meets Food™ curriculum. Health Meets Food™ improves adherence to a nutritious diet, reduces food costs by encouraging more home food preparation, and reduces blood pressure and cholesterol among people with diabetes. |
|
Experimental: Condition 15: Pantry and SMS
Pantry provisions and text messages
|
Participants will receive four culturally tailored SMS and MMS texts per week with motivational messages and nutrition education developed and tested by Dr. Leng as part of the SANOS trial (R01MD012819) and slightly adapted to our community's food preferences identified through extensive preliminary research.
Texts will be delivered in the participants preferred language (English/Spanish) and scheduled for their preferred time (e.g., AM/PM).
|
|
Sin intervención: Condition 16: Pantry only
Pantry provisions
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diet
Periodo de tiempo: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
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24-hour recall based on recommendations from the National Cancer Institute and prior evidence suggesting feasibility and validity of the measure with Spanish speakers.
Diet will be assessed using 24-hour recall administered via the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) in English and Spanish.
Will be used to calculate a Healthy Eating Index (HEI) score.
The HEI is a scale from 0 to 100.
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Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Household food security
Periodo de tiempo: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Measured using the USDA 6-item household food security survey and will be treated as a continuous variable if normally distributed or a categorical variable if data is non-normal.
Categorical scoring will be based on USDA recommendations (0-1 affirmative responses = high or marginal food security, 2-4 = low food security, 5-6 = very low food security).
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period (Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
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Percent body weight change
Periodo de tiempo: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Will be calculated as (Baseline weight minus follow-up weight) / (Baseline weight) x 100.
Height and weight will be measured using an externally validated and calibrated Tanita DC-240MA scale.
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
|
Hemoglobin A1C (HbA1c)
Periodo de tiempo: Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Will be measured using the externally validated point-of-care instrument, DCA VantageAnalyzer (1μl finger stick, nonfasting).
This method has been implemented in food pantries and is less invasive and more cost effective than a venous blood draw.
|
Recorded at baseline (Appt 1, prior to randomization), midpoint (Appt 2, month 3), immediately following the intervention period(Appt 3, month 6), and three months post-intervention (Appt 4, month 9).
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Adherence
Periodo de tiempo: Through study completion, an average of 6 months (Baseline through 6 months)
|
Number of meal kits eaten by the participant per month divided by number of meal kits selected per month, number of no-prep meals eaten per month divided by number of no-prep meals selected per month, number of culinary nutrition classes completed, and number of texts read.
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Through study completion, an average of 6 months (Baseline through 6 months)
|
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Implementation Outcomes
Periodo de tiempo: The entirety of the participant being enrolled (6 months)
|
Will measure early-stage implementation outcomes with the follow-up questionnaire (acceptability [intervention satisfaction measures] and through administrative tracking: intervention fidelity (adherence to assigned intervention components [e.g., eating meals, attending classes, etc.] and study protocols [e.g., attending appointments]).
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The entirety of the participant being enrolled (6 months)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kelseanna Hollis-Hansen, PhD, MPH, Tufts 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 (Estimado)
1 de enero de 2027
Finalización primaria (Estimado)
1 de febrero de 2031
Finalización del estudio (Estimado)
1 de febrero de 2031
Fechas de registro del estudio
Enviado por primera vez
8 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
14 de julio de 2026
Publicado por primera vez (Actual)
20 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
14 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Trastornos Nutricionales
- Enfermedades metabólicas
- Sobrenutrición
- Peso corporal
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Exceso de peso
- Obesidad
- Diabetes Mellitus, Tipo 2
- Alimento
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Comida y bebidas
- Comidas rápidas
Otros números de identificación del estudio
- STUDY00006929
- 1R01DK145891-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Marco de tiempo para compartir IPD
June 2027
Criterios de acceso compartido de IPD
The study protocol and informed consent sheet will be published along with an open-access peer reviewed protocol manuscript.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- CIF
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. .