Integrated Weight Loss Technologies for Weight and Blood Pressure Control in Urban Clinics
21 Years
N/A
Both
Obesity, Hypertension
Trial Information
Integrated Weight Loss Technologies for Weight and Blood Pressure Control in Urban Clinics
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change in body mass index (BMI)
Outcome Time Frame:
Measured at Year 2
Safety Issue:
No
Principal Investigator
Graham A. Colditz, MD, DrPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Washington University School of Medicine
Authority:
United States: Federal Government
Study ID:
448
NCT ID:
NCT00661817
Start Date:
November 2006
Completion Date:
April 2011
Related Keywords:
- Obesity
- Hypertension
- Exercise
- Physical Fitness
- Patient Compliance
- Health Behavior
- Hypertension
- Obesity
- Weight Loss
Name | Location |
|---|---|
| Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
