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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)

2012年3月3日 更新者: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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

365

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Massachusetts
      • Boston、Massachusetts、美国、02115
        • Dana Farber Cancer Institute

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.
实验性的: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.
其他名称:
  • ES+SS (Environmental Support + Social Support)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Change in body mass index (BMI)
大体时间:Measured at Year 2
Measured at Year 2

次要结果测量

结果测量
大体时间
Reduction in blood pressure
大体时间:Measured at Year 2
Measured at Year 2

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2006年11月1日

初级完成 (实际的)

2011年4月1日

研究完成 (实际的)

2011年4月1日

研究注册日期

首次提交

2008年4月16日

首先提交符合 QC 标准的

2008年4月16日

首次发布 (估计)

2008年4月18日

研究记录更新

最后更新发布 (估计)

2012年3月6日

上次提交的符合 QC 标准的更新

2012年3月3日

最后验证

2012年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 448
  • U01HL087071 (美国 NIH 拨款/合同)
  • U01HL087071-01 (美国 NIH 拨款/合同)
  • RFA-HL-007

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Usual Care and Reading Materials的临床试验

3
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