Biobehavioral Bases & Management of Metabolic Syndrome (CHARMS) (CHARMS)
30 de noviembre de 2012 actualizado por: Neil Schneiderman, University of Miami
Biobehavioral Bases & Management of Metabolic Syndrome
The metabolic syndrome is increasingly being recognized as a major threat to good health - especially cardiovascular health - and its frequency appears to be increasing in relation to the current epidemic of obesity.
The objective of this study is to determine whether a program of enhanced lifestyle intervention can, compared to standard care, reduce the frequency and severity of the metabolic syndrome as assessed by clinical, metabolic, inflammatory and vascular outcome measures.
EC will consist of a 17-session structured, lifestyle intervention plan, directed at achieving weight reduction and increasing physical activity change through education, behavior modification and stress management, and conducted in groups.
It will comprise a 3-month Core Curriculum of 8 sessions, followed by a Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in breaking through barriers in working with socioeconomically disadvantaged members of minority groups.
All participants will have baseline, 6-monthly and 1-year assessments.
This project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may contribute to the progression or amelioration of atherosclerotic processes underlying the pathogenesis of coronary heart disease (CHD).
Descripción general del estudio
Descripción detallada
The metabolic syndrome is increasingly being recognized as a major threat to good health - especially cardiovascular health - and its frequency appears to be increasing in relation to the current epidemic of obesity.
The objective of this study is to determine whether a program of enhanced lifestyle intervention can, compared to standard care, reduce the frequency and severity of the metabolic syndrome as assessed by clinical, metabolic, inflammatory and vascular outcome measures.
The project will compare the effects of Enhanced Care (EC) in 112 patients (80 completers) to Standard Care (SC) in 112 patients (80 completers) over a 12-month period.
Following 3 run-in sessions given to both SC and EC participants, eligible subjects randomized to SC will receive lifestyle modification advice as recommended management of the metabolic syndrome and this will be administered at the baseline and the 6 month assessment visits.
EC will consist of a 17-session structured, lifestyle intervention plan, directed at achieving weight reduction and increasing physical activity change through education, behavior modification and stress management, and conducted in groups.
It will comprise a 3-month Core Curriculum of 8 sessions, followed by a Maintenance phase with 9 monthly sessions delivered by lifestyle counselors, experienced in breaking through barriers in working with socioeconomically disadvantaged members of minority groups.
All participants will have baseline, 6-monthly and 1-year assessments.
This project, Project 2, entitled Community Health Approaches to Reducing Risk in the Metabolic Syndrome (CHARMS), seeks to study psychosocial and behavioral (lifestyle) variables that may contribute to the progression or amelioration of atherosclerotic processes underlying the pathogenesis of coronary heart disease (CHD).
Outcome variables will include measures of glycemic control/insulin resistance and/or dyslipidemia, oxidative stress, inflammation and overt manifestations of disease.
Tipo de estudio
Intervencionista
Inscripción (Actual)
112
Fase
- No aplica
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
30 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Men and women
- Age 30-70 years
- Language: English or Spanish
- At least 3 features of the NCEP ATP-III metabolic syndrome
Exclusion Criteria:
- Diabetes
- Established CVD
- Uncontrolled hypertension (systolic BP >160 and diastolic BP >100 mm Hg)
- Established liver disease
- Renal insufficiency
- Psychiatric illness
- Chronic substance abuse within the past 5 years
- Chronic obstructive pulmonary disease or severe asthma.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Lifestyle counseling
CHARMS Intervention Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention.
Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session.
The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly.
Each session was approximately 1-2 hrs.
At the beginning of each session anthropometric, physical activity and dietary data were collected.
Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began.
Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being.
Participants were given homework assignments to incorporate covered material into their daily lives.
Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
|
Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention.
Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session.
The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly.
Each session was approximately 1-2 hrs.
At the beginning of each session anthropometric, physical activity and dietary data were collected.
Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began.
Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being.
Participants were given homework assignments to incorporate covered material into their daily lives.
Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Weight loss
Periodo de tiempo: 1 year
|
Weight will be checked during each intervention session with the goal of losing 7% of total body weight from the enrollment date.
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measures of glycemic control/insulin resistance.
Periodo de tiempo: 1 year
|
Secondary outcomes measures will include glycemic control aka insulin resistance.
|
1 year
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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
1 de marzo de 2008
Finalización primaria (Actual)
1 de diciembre de 2011
Finalización del estudio (Actual)
1 de diciembre de 2011
Fechas de registro del estudio
Enviado por primera vez
27 de noviembre de 2012
Primero enviado que cumplió con los criterios de control de calidad
30 de noviembre de 2012
Publicado por primera vez (Estimar)
4 de diciembre de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
4 de diciembre de 2012
Última actualización enviada que cumplió con los criterios de control de calidad
30 de noviembre de 2012
Última verificación
1 de noviembre de 2012
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- P01 HL 36588- Proj 2
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. .