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Evaluating a Blood Pressure Reduction and Weight Loss Program in a Low Income, Ethnically Diverse Population (The Be Fit, Be Well [BFBW] Study) (BFBW)

3 de marzo de 2012 actualizado por: Graham Colditz, Washington University School of Medicine

Integrated Weight Loss Technologies for Weight and Blood Pressure Control in Urban Clinics

Obesity is a serious health problem that is a contributing factor for heart disease and high blood pressure. This study will evaluate a lifestyle modification program that aims to encourage weight loss and improve the health of people with high blood pressure from low income and minority communities.

Descripción general del estudio

Descripción detallada

Obesity is a serious health problem in the United States, particularly among lower income and racial and ethnic minority populations. These populations have a high risk of developing heart disease and high blood pressure, and obesity is likely a contributing factor for both conditions. African-Americans, in particular, experience an earlier onset of high blood pressure and suffer more severe health consequences as a result, than do other racial and ethnic groups. This study will evaluate the effectiveness of a lifestyle modification program that will focus on reducing blood pressure levels and encouraging weight loss among patients at community health centers that serve a primarily low-income, ethnically diverse population. Researchers will also evaluate the cost effectiveness of the lifestyle modification program.

This 2-year study will enroll people who have high blood pressure. Participants will attend a baseline study visit to complete health questionnaires. They will then be randomly assigned to either receive usual care along with printed materials about maintaining a healthy weight or take part in the lifestyle modification program that incorporates health information technologies. Participants assigned to the program will visit the BFBW study Web site several times a week to review educational and motivational information. They may receive automated weekly phone calls that will prompt them to answer questions and assist them in setting goals for losing weight and managing their blood pressure. A study researcher will call participants every 6 weeks to discuss any problems and to invite participants to take part in optional walking groups or other group activities. Participants will attend group support sessions every other month and will wear a pedometer to track their walking habits. For all participants, study visits will occur at baseline and Months 6, 12, 18, and 24. All visits will include weight and blood pressure measurements, health questionnaires, and physician referrals if needed.

Tipo de estudio

Intervencionista

Inscripción (Actual)

365

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.

Ubicaciones de estudio

    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Dana Farber Cancer Institute

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

21 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • High blood pressure that is being treated with medication
  • BMI between 30 and 50 kg/m2
  • Weighs no more than 400 lbs
  • Willing to change diet, physical activity levels, and weight
  • Willing to be assigned to either study group
  • Patient of a participating community health center with a record of at least one medical visit in the 12 months before study entry
  • Primary care provider approval is needed for people with the following conditions: diabetes mellitus, a prior cardiovascular event more than 6 months before study entry, known stable cardiovascular or peripheral vascular disease

Exclusion Criteria:

  • Experienced a heart attack, stroke, or an atherosclerotic cardiovascular disease (ASCVD) procedure in the 6 months before study entry
  • Serious medical condition that is likely to interfere with an accurate measurement of weight, for which weight loss is not medically advisable, or that would cause weight loss (e.g., end-stage renal disease [ESRD] and on dialysis; diagnosis or treatment for cancer in the 2 years before study entry, other than non-melanoma skin cancer)
  • Prior or planned bariatric surgery
  • Use of FDA-approved prescription weight loss medication, including off label drugs (e.g., topiramate, bupropion, byetta) or over-the-counter orlistat in the 6 months before study entry
  • Long-term use (i.e., in the 6 months before study entry) of medications likely to cause weight gain or prevent weight loss (e.g., corticosteroids, lithium, olanzapine, risperidone, clozapine)
  • Pregnant or breastfeeding in the 6 months before study entry
  • Plans to become pregnant in the 2 years after study entry
  • Plans to relocate from the area in the 2 years after study entry
  • Another member of household is a study participant or study staff member
  • Principal investigator decides that the individual is not suitable for the study

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 paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 1
Participants in this group will receive usual medical care and reading materials on weight loss.
Participants in this group will receive usual medical care provided by their own primary care providers. They will also receive the NHLBI's "Aim for a Healthy Weight" brochure at the baseline study visit and again at the beginning of Year 2.
Experimental: 2
Participants in this group will take part in the lifestyle modification program.
Participants will receive a behavior change "prescription" and skills training, offered via the Internet or through a combination of tailored print materials and an interactive voice response system, together with support strategies to enhance the intensity of the interpersonal and social-environmental support.
Otros nombres:
  • ES+SS (Environmental Support + Social Support)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change in body mass index (BMI)
Periodo de tiempo: Measured at Year 2
Measured at Year 2

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Reduction in blood pressure
Periodo de tiempo: Measured at Year 2
Measured at Year 2

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Graham A. Colditz, MD, DrPH, Washington University School of Medicine
  • Investigador principal: Gary G. Bennett, PhD, Dana Farber Cancer Institute/Harvard School of Public Health
  • Investigador principal: Karen M. Emmons, PhD, Dana Farber Cancer Institute/Harvard School of Public Health

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 noviembre de 2006

Finalización primaria (Actual)

1 de abril de 2011

Finalización del estudio (Actual)

1 de abril de 2011

Fechas de registro del estudio

Enviado por primera vez

16 de abril de 2008

Primero enviado que cumplió con los criterios de control de calidad

16 de abril de 2008

Publicado por primera vez (Estimar)

18 de abril de 2008

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

6 de marzo de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

3 de marzo de 2012

Última verificación

1 de marzo de 2012

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 448
  • U01HL087071 (Subvención/contrato del NIH de EE. UU.)
  • U01HL087071-01 (Subvención/contrato del NIH de EE. UU.)
  • RFA-HL-007

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. .

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