Status:
COMPLETED
Effect of Exercise and Weight Loss on Cardiovascular Health
Lead Sponsor:
University of Pittsburgh
Conditions:
Cardiovascular Disease
Obesity
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The primary aim of this study is to examine the effect of the consensus public health recommended level of physical activity \[moderate physical activity (MOD-PA) = 150 min/wk\] versus a higher dose o...
Detailed Description
Current estimates indicate that in excess of 65 percent of adults in the United States are overweight (BMI \>25.0 kg/m2) with at least 30 percent of adults classified as obese (BMI \>30 kg/m2). Overwe...
Eligibility Criteria
Inclusion
- 18-55 years of age.
- Body mass index (BMI) between 25.0 to \<40.0 kg/m2.
- Ability to provide informed consent prior to participation in this study.
Exclusion
- Females who are currently pregnant or breastfeeding, or reporting that she is planning a pregnancy within the next 12 months.
- History of bariatric surgery.
- Report current medical condition or treatment for a medical condition that could affect body weight. These may include the following: cancer (Note: Persons previously diagnosed with non-melanoma skin cancers, those successfully treated for cancer who have remained disease-free for five years or more would be eligible for participation in this study); diabetes mellitus; hyperthyroidism; inadequately controlled hypothyroidism; chronic renal insufficiency; chronic liver disease; gastrointestinal disorders including ulcerative colitis, Crohn's disease, or malabsorption syndromes; etc.
- Current congestive heart failure, angina, uncontrolled arrhythmia, symptoms indicative of an increased acute risk for a cardiovascular event, prior myocardial infarction, coronary artery bypass grafting or angioplasty, conditions requiring chronic anticoagulation (i.e. recent or recurrent DVT).
- Resting systolic blood pressure of \>160 mmHg or resting diastolic blood pressure of \>100 mmHg.
- Eating disorders that would contraindicate weight loss or physical activity.
- Alcohol or substance abuse.
- Currently treated for psychological issues (i.e., depression, bipolar disorder, etc), taking psychotropic medications within the previous 12 months, or hospitalized for depression within the previous 5 years.
- Report exercise on \>3 days per week for \>20 minutes per day over the past 3 months. (NOTE: It is important that individuals are sedentary when entering this study to allow for maximal effect of the intervention.)
- Report weight loss of \>5% or participating in a weight reduction diet in the past 3 months.
- Report plans to relocate to a location not accessible to the study site or having employment, personal, or travel commitments that prohibit attendance to at least 80 percent of the scheduled intervention sessions and all of the scheduled assessments.
Key Trial Info
Start Date :
December 13 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2016
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT01500356
Start Date
December 13 2011
End Date
June 30 2016
Last Update
July 25 2017
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260