Overview

This trial is active, not recruiting.

Conditions cardiovascular disease, obesity
Treatments behavioral weight loss intervention, diet plus moderate exercise, diet plus high exercise
Sponsor University of Pittsburgh
Start date December 2011
End date July 2016
Trial size 383 participants
Trial identifier NCT01500356, HL103646

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 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Weight loss intervention that focuses only on reducing energy intake of the diet.
behavioral weight loss intervention
Weight loss intervention that focuses on reducing energy intake.
(Experimental)
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.
diet plus moderate exercise
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.
(Experimental)
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.
diet plus high 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.

Primary Outcomes

Measure
Change in Left ventricular mass assessed using cardiac MRI
time frame: Baseline (0 months) and 12 months

Secondary Outcomes

Measure
Change in aortic pulse wave velocity
time frame: baseline (0 months) and 12 months
Change in end-diastolic volume assessed using cardiac MRI
time frame: baseline (0 months) and 12 months
Change in cardiorespiratory fitness
time frame: baseline (0 months) 6 months, and 12 months
Change in blood levels of C-Reactive Protein (CRP), tumor necrosis factor-α (TNFα), and adiponectin
time frame: baseline (0 months), 6 months, and 12 months
Change in aortic distensibility assessed using cardiac MRI
time frame: baseline (0 months) and 12 months
Change in body weight
time frame: baseline (0 months), 6 months, and 12 months
Change in body composition
time frame: baseline (0 months), 6 months, and 12 months
Change in regional adiposity
time frame: baseline (0 months), 6 months, 12 months
Change in physical activity
time frame: baseline (0 months), 6 months, 12 months
Change in energy intake
time frame: baseline (0 months), 6 months, 12 months
Change in traditional CVD risk factors (lipids, glucose, insulin)
time frame: baseline (0 months), 6 months, 12 months
Change in resting blood pressure
time frame: baseline (0 months), 6 months, 12 months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

Official title Effect of Exercise and Weight Loss on Cardiovascular Health
Principal investigator John M. Jakicic, PhD
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). 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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by University of Pittsburgh.