- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07609368
Teaching Kitchens Intervention for Older Adults in a Senior Center in New England
19 de mayo de 2026 actualizado por: Tufts University
A Pilot Teaching Kitchens Intervention Protocol to Improve the Dietary Quality of Congregate Meals for Older Adults
This study will evaluate a culinary nutrition intervention designed to improve the quality of meals served to older adults participating in a senior center.
Many meals currently provided in these settings do not meet recommended dietary guidelines, which negatively impact health outcomes among older adults.
In this pilot study, participants will receive improved lunch meals that are designed to be more nutritious, culturally appropriate, and acceptable, along with nutrition education sessions over a 6-month period.
This intervention will also include training for food service staff to support implementation of the improved meals.
The study will assess changes in dietary quality, physical health measures, and social and behavioral outcomes among participants at baseline, 3 months, and 6 months.
Findings from this study will help determine the feasibility and effectiveness of this approach and inform future efforts to improve nutrition and health outcomes in Congregate Meal Program for older adults.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Congregate meal programs within senior centers serve a large population of older adults in the United States, yet many meals provided in these settings do not meet recommended dietary guidelines particularly for whole grains, micronutrients, sodium, and saturated fat.
Poor dietary quality in this population may contribute to increased risk of chronic diseases, reduced physical function, and lower overall well-being.
This study is a Phase III pilot feasibility study designed to evaluate a culinary nutrition intervention implemented in a senior meal center serving older adults.
The intervention is based on a Teaching Kitchens model and includes three core components: (1) development and implementation of a nutritionally improved lunch menu, (2) training of food service staff to prepare healthier and culturally appropriate meals, and (3) delivery of nutrition education sessions to meal recipients.
The intervention will be conducted over a 6-month period.
Participants will receive reformulated lunch meals designed to improve dietary quality, alongside structured nutrition education sessions aimed at increasing nutritional literacy, supporting healthy food choices, and promoting engagement in the meal program.
The effectiveness of the intervention will be evaluated by measuring changes in dietary quality, physical health indicators, and psychosocial outcomes at baseline, 3 months, and 6 months.
Outcomes will include dietary intake, anthropometric measures (e.g., body weight, hip-to-waist circumference, height), blood pressure, food security, and measures of social engagement and well-being.
This study aims to assess the feasibility and preliminary effectiveness of a scalable culinary nutrition intervention tailored to older adults in Congregate meal settings.
Findings from this pilot study will inform the development of larger-scale interventions and may contribute to improving nutrition and health outcomes for older adults in similar programs.
Tipo de estudio
De observación
Inscripción (Estimado)
30
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: Andres V Ardisson Korat, ScD
- Número de teléfono: 617-556-3386
- Correo electrónico: andres.ardisson_korat@tufts.edu
Copia de seguridad de contactos de estudio
- Nombre: Meghan Hendricksen, Ph.D
- Número de teléfono: 617-556-3384
- Correo electrónico: meghan.hendricksen@tufts.edu
Ubicaciones de estudio
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Connecticut
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Glastonbury, Connecticut, Estados Unidos, 06033
- Glastonbury Senior Center
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Contacto:
- Ronda Guberman, Senior Center Supervisor
- Número de teléfono: 860-652-7646
- Correo electrónico: ronda.guberman@glastonbury-ct.gov
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
The participants for this study are senior center members either of the current lunch program or other programming events at "The Senior Center" in Glastonbury, Connecticut.
Descripción
Inclusion Criteria:
- Age 50 years or older
- Regularly visits the Senior Center either for lunch meals or other center-based programming
- Willing and able to participate in a 6-month intervention, which includes consistent involvement in the lunch program
- Willing and able to participate in multiple focus group discussions centered around meal preferences, health perceptions, and dietary habits (full study participation is 7 months)
- Capable of providing informed consent and completing an eligibility screening
Exclusion Criteria:
- History of moderate to severe neurological condition(s) that may impact cognitive ability (e.g., dementia, major stroke)
- Known severe food allergies that may interfere with participation. (with study MD approval, participants with mild allergies or intolerances may be included and notified not to consume any known allergens)
- Recent changes in health status that affect the ability to assess foods (e.g., altered appetite, smell, vision, hearing, and/or taste)
- Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which, in either the investigator's or study MD's opinion, might jeopardize the subject's compliance with the protocol. This includes impaired vision requiring assistance or aid from another person, impaired smell, or impaired taste perception. Given the number of written surveys and visual support materials, the study would place a large burden on participation for individuals with visual impairment requiring assistance.
- Individuals who have a cognitive, sensory, or physical impairment that prevents them from understanding the consent information or completing the required consent documentation will be excluded from participation.
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
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Senior Center Meal Recipients
Adults aged 50+ who regularly attend The Senior Center in Glastonbury, CT and participate in the 6-month culinary nutrition intervention, including redesigned lunch meals, nutrition education sessions, focus groups, and dietary/health assessments.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean change from baseline to 6 months in dietary quality among meal recipients
Periodo de tiempo: Baseline to 6 months
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The mean change from baseline to 6 months in dietary quality among meal recipients will be measured using the healthy eating index (HEI) and individual components of the HEI.
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Baseline to 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Satisfaction in meal program from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
|
The satisfaction in meal program will be measured using the meal program satisfaction questionnaire from baseline to 6 months.
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Baseline to 6 months
|
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Mean meal consumption scores from baseline to 6 months
Periodo de tiempo: Weeks 3 and 7 of meal implementation
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The mean meal consumption scores will be measured through visual assessment of food discarded during weeks 3 and 7 using the official plate waste analysis guide.
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Weeks 3 and 7 of meal implementation
|
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Mean change in nutrition literacy from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
|
The mean change in nutrition literacy will be assessed using a nutritional literacy survey for older adults from baseline to 6 months.
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Baseline to 6 months
|
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Mean change in blood pressure from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
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The mean change in blood pressure (systolic/diastolic) will be assessed using an automated sphygmomanometer.
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Baseline to 6 months
|
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Mean change in body weight from baseline to 6 months
Periodo de tiempo: baseline to 6 months
|
The mean change in body weight will be assessed using a digital scale from baseline to 6 months.
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baseline to 6 months
|
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Mean change in waist circumference from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
|
The mean change in waist circumference using a tape measure will be assessed from baseline to 6 months.
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Baseline to 6 months
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Mean change in hip circumference from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
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The mean change in hip circumference using a tape measure will be assessed from baseline to 6 months.
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Baseline to 6 months
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Mean change in waist-to-hip circumference ratio from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
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The mean change in waist-to-hip circumference ratio will be mathematically calculated from the hip and waist measurements.
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Baseline to 6 months
|
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Mean change in height from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
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The mean change in height will be assessed using a stadiometer from baseline to 6 months.
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Baseline to 6 months
|
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Mean change in body mass index (BMI) from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
|
The mean change in body mass index will be mathematically calculated from the body weight and height measurements from baseline to 6 months.
|
Baseline to 6 months
|
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Mean change in Food and Nutrition Insecurity from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
|
The mean change in food and nutrition insecurity will be measured through validated questionnaires (e.g., US Household Food Security Survey Module) from baseline to 6 months.
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Baseline to 6 months
|
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Mean Change in Loneliness and Socialization Measures from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
|
The mean change in loneliness and socialization measures using validated questionnaires (e.g., Socialization questionnaire) from baseline to 6 months.
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Baseline to 6 months
|
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Mean change in frequency of meal participation and participation in other activities at the Senior Center from baseline to 6 months
Periodo de tiempo: Baseline to 6 months
|
The mean change in frequency of meal participation and participation in other activities at the Senior Center will be assessed using the current Senior Center's attendance log.
|
Baseline to 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: Andres V Ardisson Korat, ScD, Tuft's 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 julio de 2026
Finalización primaria (Estimado)
1 de marzo de 2027
Finalización del estudio (Estimado)
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
19 de mayo de 2026
Publicado por primera vez (Actual)
27 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
19 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- STUDY00007007
- 58-8050-3-003 (Otro número de subvención/financiamiento: USDA Cooperative Agreement)
- PT0445 (Otro número de subvención/financiamiento: Danone Institute of North America)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Participant privacy given the small sample size (n=30)
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. .