Evaluating a Blood Pressure Reduction and Weight Loss Program in a Low Income, Ethnically Diverse Population (The Be Fit, Be Well [BFBW] Study)
NCT ID: NCT00661817
Last Updated: 2012-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
365 participants
INTERVENTIONAL
2006-11-30
2011-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of a Technology-based System and an In-person Behavioral Weight Loss Intervention in the Severely Obese
NCT01537796
Innovative Approaches to Diet, Exercise and Activity
NCT01131871
The Effects of a Weight Management Program on Body Weight and Quality of Life
NCT02219763
Prescription of Step Counts for Targeted Changes in Body Composition and Cardiometabolic Risk in Overweight/Obese Adults
NCT07221279
A Maintenance Program for the Be Fit Employee Wellness Program
NCT00707577
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Participants in this group will receive usual medical care and reading materials on weight loss.
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.
2
Participants in this group will take part in the lifestyle modification program.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Washington University School of Medicine
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Graham Colditz
Niess-Gain Professor in the School of Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Graham A. Colditz, MD, DrPH
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Gary G. Bennett, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana Farber Cancer Institute/Harvard School of Public Health
Karen M. Emmons, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana Farber Cancer Institute/Harvard School of Public Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ritzwoller DP, Glasgow RE, Sukhanova AY, Bennett GG, Warner ET, Greaney ML, Askew S, Goldman J, Emmons KM, Colditz GA; Be Fit Be Well study investigators. Economic analyses of the Be Fit Be Well program: a weight loss program for community health centers. J Gen Intern Med. 2013 Dec;28(12):1581-8. doi: 10.1007/s11606-013-2492-3. Epub 2013 Jun 4.
Warner ET, Glasgow RE, Emmons KM, Bennett GG, Askew S, Rosner B, Colditz GA. Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: results and lessons learned. BMC Public Health. 2013 Mar 6;13:192. doi: 10.1186/1471-2458-13-192.
Bennett GG, Warner ET, Glasgow RE, Askew S, Goldman J, Ritzwoller DP, Emmons KM, Rosner BA, Colditz GA; Be Fit, Be Well Study Investigators. Obesity treatment for socioeconomically disadvantaged patients in primary care practice. Arch Intern Med. 2012 Apr 9;172(7):565-74. doi: 10.1001/archinternmed.2012.1. Epub 2012 Mar 12.
Yeh HC, Clark JM, Emmons KE, Moore RH, Bennett GG, Warner ET, Sarwer DB, Jerome GJ, Miller ER, Volger S, Louis TA, Wells B, Wadden TA, Colditz GA, Appel LJ. Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group. Clin Trials. 2010 Aug;7(4):322-32. doi: 10.1177/1740774510374213. Epub 2010 Jun 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.