- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00241813
Effects of Behavioral Stress Reduction Programs on Blood Pressure in African American Youth
Stress Reduction: Impact on Blood Pressure in African American Youth
Descripción general del estudio
Estado
Descripción detallada
BACKGROUND:
African Americans (AA) experience a high prevalence and early onset of essential hypertension (EH), which has been partly attributed to exposure to chronic environmental stress. AA youth exhibit higher resting blood pressure (BP) than whites. Since BP ranking tracks from late childhood onward, AA adolescents with high normal BP are at increased risk for development of EH. The need for developing effective primary prevention programs for EH is highlighted by the fact that EH is now a pediatric problem due to recent increased prevalence among youth. There have been no previous controlled studies evaluating stress reduction approaches on BP control in AA youth, particularly within the framework of an underlying psychological and physiological-based model of stress-induced EH.
This study is in response to a 'Request for Applications' entitled "Research on Mind-Body Interactions and Health," which was issued by the Office of the Director, National Institutes of Health (NIH).
DESIGN NARRATIVE:
This study will examine the effects of two behavioral stress reduction programs, MM and LP, and CTL on cardiovascular function at rest, during laboratory stress, and in the natural environment. Participants will include 320 ninth graders (50% male) with high normal systolic BP (SBP) (SBP ranging from greater than or equal to the 50th percentile to less than or equal to the 95th percentile on three occasions). Following BP screenings and baseline evaluation, participants will be assigned to a CTL, MM, LP, or MM plus LP group. Participants will be re-evaluated after a 12-week intervention and again at a 12-week follow-up. The specific aims of this study are to determine whether MM and/or LP results in the following: 1) decreases in the primary outcome variables of resting SBP and 24-hour ambulatory SBP; 2) decreases in sympathetic nervous system (SNS) tone (decreased overnight urine norepinephrine [NE] excretion) and decreases in sodium intake (decreased overnight sodium excretion); 3) decreases in SBP reactivity to behavioral stressors; 4) decreases in SNS arousal (decreased urinary NE excretion) and greater increases in renal function (increased urinary sodium excretion) to the behavioral stressors; 5) decreases in self-reported hostility and anger; 6) improvement in vascular function (increases in percent of endothelium-dependent arterial vasodilation to reactive hyperemia); and 7) improvement in ventricular structure and function (decreases in left ventricular mass index and resting heart rate). It is anticipated that the combination of MM and LP will result in greater positive impacts than either treatment alone. The study will be conducted by teachers during school health classes. If these programs are shown to be successful, they may be incorporated into the regular school curriculum.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
South Carolina
-
Charleston, South Carolina, Estados Unidos, 29425
- Medical University of South Carolina
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- In ninth grade
- SBP ranging from greater than or equal to 50th percentile to less than or equal to 95th percentile on three occasions
Exclusion Criteria:
- Clinical Hypertension
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Health Education Control Program (CTL)
|
Participants will take part in a health education control program (CTL)
|
Experimental: Mindfulness Meditation
Mindfulness Meditation (MM) Program
|
Participants will take part in a mindfulness meditation (MM) program.
|
Experimental: Lifeskills
Lifeskills Program (LP)
|
Participants will take part in a lifeskills program (LP).
|
Experimental: MM plus LP
Mindfulness Meditation (MM) Program plus Lifeskills Program (LP)
|
Participants will take part in a mindfulness meditation (MM) program.
Participants will take part in a lifeskills program (LP).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Resting SBP and 24-hour ambulatory SBP
Periodo de tiempo: Measured after 12-week intervention and at 12-week follow-up
|
Measured after 12-week intervention and at 12-week follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Overnight urine NE excretion
Periodo de tiempo: Measured after 12-week intervention and at 12-week follow-up
|
Measured after 12-week intervention and at 12-week follow-up
|
Overnight sodium excretion
Periodo de tiempo: Measured after 12-week intervention and at 12-week follow-up
|
Measured after 12-week intervention and at 12-week follow-up
|
SBP reactivity to behavioral stressors
Periodo de tiempo: Measured after 12-week intervention and at 12-week follow-up
|
Measured after 12-week intervention and at 12-week follow-up
|
Self-reported hostility and anger
Periodo de tiempo: Measured after 12-week intervention and at 12-week follow-up
|
Measured after 12-week intervention and at 12-week follow-up
|
Percent of endothelium-dependent arterial vasodilation to reactive hyperemia
Periodo de tiempo: Measured after 12-week intervention and at 12-week follow-up
|
Measured after 12-week intervention and at 12-week follow-up
|
Left ventricular mass index and resting heart rate
Periodo de tiempo: Measured after 12-week intervention and at 12-week follow-up
|
Measured after 12-week intervention and at 12-week follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Frank A. Treiber, Ph.D., Medical University of South Carolina
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 330
- R01HL078216 (Subvención/contrato del NIH de EE. UU.)
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. .
Ensayos clínicos sobre Enfermedades cardíacas
-
Region SkaneInscripción por invitaciónInsuficiencia cardíaca New York Heart Association (NYHA) Clase II | Insuficiencia cardíaca New York Heart Association (NYHA) Clase IIISuecia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... y otros colaboradoresAún no reclutandoInsuficiencia Cardíaca Sistólica | Insuficiencia cardíaca con fracción de eyección reducida | Insuficiencia cardíaca Clase IV de la New York Heart Association | Insuficiencia cardíaca Clase III de la New York Heart AssociationPolonia
-
Novartis PharmaceuticalsTerminadoPacientes que completaron con éxito el período de tratamiento de 12 meses del estudio principal (receptores de Novo Heart) que estaban interesados en recibir tratamiento con EC-MPS
-
University of WashingtonAmerican Heart AssociationTerminadoInsuficiencia cardíaca, congestiva | Alteración mitocondrial | Insuficiencia cardíaca Clase IV de la New York Heart AssociationEstados Unidos
Ensayos clínicos sobre Health Education Control Program (CTL)
-
University of SheffieldUniversity of Liverpool; University of Manchester; University of MelbourneActivo, no reclutandoDesarrollo del lenguajeReino Unido
-
Massachusetts General HospitalActivo, no reclutandoCáncer de pulmón de células no pequeñas | Mesotelioma | Cáncer de pulmón de células pequeñas | Terapia de conducta cognitivaEstados Unidos
-
Radicle ScienceActivo, no reclutandoDolor abdominal | Digestión | Trastornos gastrointestinalesEstados Unidos
-
VA Office of Research and DevelopmentReclutamientoAmputación de miembros inferioresEstados Unidos
-
Radicle ScienceTerminadoDepresión | Dolor | Dormir | AnsiedadEstados Unidos
-
Celero Systems, Inc.Reclutamiento
-
Radicle ScienceActivo, no reclutandoDolor abdominal | Digestión | Trastornos gastrointestinalesEstados Unidos
-
Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation TrustActivo, no reclutandoOsteo Artritis Rodilla | Artrosis, CaderaReino Unido
-
Rush University Medical CenterTerminadoAtención primaria | Capacitación para padresEstados Unidos
-
University College, Londonbluebird bioActivo, no reclutandoEnfermedad linfoproliferativa postrasplante | Malignidad hematológica relacionada con el trasplanteReino Unido