An interventional study of Behavioral weight loss intervention and Diet Plus Moderate Exercise in Cardiovascular Disease and Obesity, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-25.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Treatment
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 of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.
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). Overweight and obesity have been linked to numerous chronic conditions including cardiovascular disease. The application of cardiac MRI (CMRI) allows for direct measurement of the cardiac structure, and left ventricular mass (LVM) assessed by CMRI has been shown to be predictive of cardiovascular disease. Recent studies have shown that LVM is decreased with weight loss; however, there is a lack of information on the added benefit of physical activity to weight loss on these direct measures of cardiovascular structure and function. Thus, consistent with PA-09-243, this study will examine the effect of two recommended doses of physical activity combined with a dietary intervention on changes in the proposed outcomes of cardiovascular disease risk in overweight adults.
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 of physical activity [high physical activity (HIGH-PA) = 250 min/wk] in the context of a comprehensive behavioral weight loss program that a includes a reduction in energy intake measures of cardiovascular function using cardiac MRI and biomarkers of vascular disease risk. Each of these exercise doses will be compared independently to a Diet Only group intervention on the proposed primary and secondary outcomes, with MOD-PA also compared to HIGH-PA. This study involves the recruitment of 390 overweight and obese adults who will be randomly assigned to one of the above conditions (Diet Only, MOD-PA, HIGH-PA) for a period of 12 months. The primary outcome is LVM measured by cardiac MRI. Secondary outcomes include additional cardiac MRI measures (aortic pulse wave velocity, end diastolic volume, aortic distensibility), inflammatory markers (CRP and TNFα) and selected adipocytokines (adiponectin) as biomarkers of risk related to vascular outcomes, body weight, body composition, and cardiorespiratory fitness, and traditional CVD risk factors (lipids, glucose, insulin, blood pressure). Additional secondary analyses will allow for examination of the effects of physical activity independent of weight change on the primary and secondary outcomes.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 383 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.
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Exclusion Criteria:
Weight loss intervention that focuses only on reducing energy intake of the diet.
Behavioral: Behavioral weight loss intervention
Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise.
Behavioral: Diet Plus Moderate Exercise
Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise.
Behavioral: Diet Plus High Exercise
Weight loss intervention that focuses on reducing energy intake.
Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise.
Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise.
Change in Left ventricular mass assessed using cardiac MRI
Left ventricular mass will be assessed using cardiac MRI
Time frame: Baseline (0 months) and 12 months
Change in end-diastolic volume assessed using cardiac MRI
Assessed using cardiac MRI
Time frame: baseline (0 months) and 12 months
Change in cardiorespiratory fitness
Measured using a graded exercise test
Time frame: baseline (0 months) 6 months, and 12 months
Change in blood levels of C-Reactive Protein (CRP)
Assessed from a fasting blood sample
Time frame: baseline (0 months), 6 months, and 12 months
Change in body weight
Time frame: baseline (0 months), 6 months, and 12 months
Change in body composition
Measured using dual-energy x-ray absorptiometry (DXA)
Time frame: baseline (0 months), 6 months, and 12 months
Change in regional adiposity
Measured using anthromometry that includes girth measures of the waist and hip
Time frame: baseline (0 months), 6 months, 12 months
Change in physical activity
Measured using both a wearable device and by questionnaire
Time frame: baseline (0 months), 6 months, 12 months
Change in energy intake
Assessed using a questionnaire
Time frame: baseline (0 months), 6 months, 12 months
Change in traditional CVD risk factors (lipids, glucose, insulin)
Measured from a fasting blood sample
Time frame: baseline (0 months), 6 months, 12 months
Change in resting blood pressure
Time frame: baseline (0 months), 6 months, 12 months
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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