- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05414396
Programa Eat, Move, Live para la reducción del riesgo de cáncer y enfermedades crónicas en comunidades desatendidas
Reducción del riesgo de cáncer y enfermedades crónicas en comunidades desatendidas: programa Eat, Move, Live
This clinical trial tests the Eat, Move, Live (EML) Program in reducing the risk of chronic diseases among underserved communities by improving healthy lifestyle practices, increasing physical activity and encouraging healthy eating behaviors. EML is a series of free culturally and linguistically appropriate nutrition and physical activity sessions. The interactive education segment of the EML Program is culturally responsive, and based on the community EML program, and topics will include: nutrition guidelines, reading food labels, recipe modification and healthy food preparation, eating healthy on a budget, chronic diseases information and prevention strategies. The EML program may help reduce the risk of cancer and chronic diseases by encouraging more physical activity and healthy eating behaviors.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. To evaluate program by assessing in combination with standard of care metformin: Changes in participants' knowledge, attitudes, and behavior.
II. To evaluate program by assessing in combination with standard of care metformin: Changes in body measurements.
III. To evaluate program by assessing in combination with standard of care metformin: Changes in biomarkers.
OUTLINE:
Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Duarte, California, Estados Unidos, 91010
- City of Hope Medical Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Agrees to group consent at week 1
- Age over 18
- Able to speak and understand English and/or Spanish
Exclusion Criteria:
- Don't agree to group consent at week 1
- Age younger than 18
- Not able to speak and understand English and/or Spanish
- Can't participate in physical activity
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Supportive care (EML program)
Participants attend EML program sessions weekly for 12 weeks including an educational session chronic disease risk reduction via nutrition and physical activity, a physical activity session, and a cooking/taste test demonstration. |
Ancillary studies Attend EML program sessions
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in attitudes and beliefs as measured by questionnaires from baseline to week 12
Periodo de tiempo: Baseline and week 12
|
Attitudes and beliefs regarding causes of diabetes asked in questionnaire, measured by endorsing one of the Likert-type scale values ranging from 1 (Agree) to 7 (Disagree). |
Baseline and week 12
|
|
Changes in behavior as measured by questionnaires from baseline to week 12
Periodo de tiempo: Baseline and week 12
|
Behaviors related to food consumption asked in questionnaires, measured by endorsing one of "None", "1", "2-3", "4-6", "7 or more". |
Baseline and week 12
|
|
Changes in height from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Height measured in meters |
Baseline to 12 weeks
|
|
Changes in weight from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Weight measured in Kilograms |
Baseline to 12 weeks
|
|
Changes in waist circumference from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in chest circumference from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Chest circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in right upper arm circumference from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Right upper arm circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in left upper arm circumference from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Left upper arm circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in right upper thigh circumference from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Right upper thigh circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in left upper thigh circumference from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Left upper thigh circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in body fat percentage from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Body fat percentage measured in percent using a handheld BMI machine that calculates body fat percentage. |
Baseline to 12 weeks
|
|
Changes in systolic blood pressure from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Systolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in diastolic blood pressure from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Diastolic blood pressure measured in mmHG |
Baseline to 12 weeks
|
|
Changes in hip circumference from baseline to week 12
Periodo de tiempo: Baseline to 12 weeks
|
Hip circumference measured in centimeters |
Baseline to 12 weeks
|
|
Changes in biomarkers
Periodo de tiempo: Baseline to 12 weeks
|
Will be collected at baseline and follow up based on glycosylated hemoglobin (A1C) measuring guidelines. |
Baseline to 12 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Victoria L Seewaldt, City of Hope Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 17410
- P30CA033572 (Subvención/contrato del NIH de EE. UU.)
- 17410 (Otro identificador: City of Hope Comprehensive Cancer Center)
- NCI-2022-00180 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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