NCT00661817

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 18, 2008

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

4.4 years

First QC Date

April 16, 2008

Last Update Submit

March 3, 2012

Conditions

ObesityHypertension

Keywords

ExercisePhysical FitnessPatient ComplianceHealth Behavior

Outcome Measures

Primary Outcomes (1)

  • Change in body mass index (BMI)

    Measured at Year 2

Secondary Outcomes (1)

  • Reduction in blood pressure

    Measured at Year 2

Study Arms (2)

1

ACTIVE COMPARATOR

Participants in this group will receive usual medical care and reading materials on weight loss.

Behavioral: Usual Care and Reading Materials

2

EXPERIMENTAL

Participants in this group will take part in the lifestyle modification program.

Behavioral: Lifestyle Modification Program

Interventions

Lifestyle Modification ProgramBEHAVIORAL

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.

Also known as: ES+SS (Environmental Support + Social Support)
2
Usual Care and Reading MaterialsBEHAVIORAL

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.

1

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

  • 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.

    PMID: 23733374DERIVED

  • 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.

    PMID: 23496916DERIVED

  • 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.

    PMID: 22412073DERIVED

  • 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.

    PMID: 20573639DERIVED

MeSH Terms

Conditions

ObesityHypertensionMotor ActivityPatient ComplianceHealth Behavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular DiseasesBehaviorPatient Acceptance of Health CareTreatment Adherence and Compliance

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Niess-Gain Professor in the School of Medicine

Study Record Dates

First Submitted

April 16, 2008

First Posted

April 18, 2008

Study Start

November 1, 2006

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

US(1)