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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)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Graham Colditz, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00661817
First received: April 16, 2008
Last updated: March 3, 2012
Last verified: March 2012

April 16, 2008
March 3, 2012
November 2006
April 2011   (final data collection date for primary outcome measure)
Change in body mass index (BMI) [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00661817 on ClinicalTrials.gov Archive Site
Reduction in blood pressure [ Time Frame: Measured at Year 2 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluating a Blood Pressure Reduction and Weight Loss Program in a Low Income, Ethnically Diverse Population (The Be Fit, Be Well [BFBW] Study)
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Hypertension
  • Behavioral: 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.
    Other Name: ES+SS (Environmental Support + Social Support)
  • Behavioral: Usual Care and Reading Materials
    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.
  • Active Comparator: 1
    Participants in this group will receive usual medical care and reading materials on weight loss.
    Intervention: Behavioral: Usual Care and Reading Materials
  • Experimental: 2
    Participants in this group will take part in the lifestyle modification program.
    Intervention: Behavioral: Lifestyle Modification Program

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
365
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00661817
448, U01HL087071, U01 HL087071-01, RFA-HL-007
Yes
Graham Colditz, Washington University School of Medicine
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Graham A. Colditz, MD, DrPH Washington University School of Medicine
Principal Investigator: Gary G. Bennett, PhD Dana Farber Cancer Institute/Harvard School of Public Health
Principal Investigator: Karen M. Emmons, PhD Dana Farber Cancer Institute/Harvard School of Public Health
Washington University School of Medicine
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP