Effect of Exercise and Weight Loss on Cardiovascular Health (Heart Health)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01500356
First received: December 22, 2011
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Obesity
Behavioral: Behavioral weight loss intervention
Behavioral: Diet Plus Moderate Exercise
Behavioral: Diet Plus High Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Exercise and Weight Loss on Cardiovascular Health

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Change in Left ventricular mass assessed using cardiac MRI [ Time Frame: Baseline (0 months) and 12 months ] [ Designated as safety issue: No ]
    Left ventricular mass will be assessed using cardiac MRI


Secondary Outcome Measures:
  • Change in aortic pulse wave velocity [ Time Frame: baseline (0 months) and 12 months ] [ Designated as safety issue: No ]
    Assessed using cardiac MRI

  • Change in end-diastolic volume assessed using cardiac MRI [ Time Frame: baseline (0 months) and 12 months ] [ Designated as safety issue: No ]
    Assessed using cardiac MRI

  • Change in cardiorespiratory fitness [ Time Frame: baseline (0 months) 6 months, and 12 months ] [ Designated as safety issue: No ]
    Measured using a graded exercise test

  • 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 ] [ Designated as safety issue: No ]
    Assessed from a fasting blood sample

  • Change in aortic distensibility assessed using cardiac MRI [ Time Frame: baseline (0 months) and 12 months ] [ Designated as safety issue: No ]
    Assessed using cardiac MRI

  • Change in body weight [ Time Frame: baseline (0 months), 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Change in body composition [ Time Frame: baseline (0 months), 6 months, and 12 months ] [ Designated as safety issue: No ]
    Measured using dual-energy x-ray absorptiometry (DXA)

  • Change in regional adiposity [ Time Frame: baseline (0 months), 6 months, 12 months ] [ Designated as safety issue: No ]
    Measured using anthromometry that includes girth measures of the waist and hip

  • Change in physical activity [ Time Frame: baseline (0 months), 6 months, 12 months ] [ Designated as safety issue: No ]
    Measured using both a wearable device and by questionnaire

  • Change in energy intake [ Time Frame: baseline (0 months), 6 months, 12 months ] [ Designated as safety issue: No ]
    Assessed using a questionnaire

  • Change in traditional CVD risk factors (lipids, glucose, insulin) [ Time Frame: baseline (0 months), 6 months, 12 months ] [ Designated as safety issue: No ]
    Measured from a fasting blood sample

  • Change in resting blood pressure [ Time Frame: baseline (0 months), 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: December 2011
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet alone
Weight loss intervention that focuses only on reducing energy intake of the diet.
Behavioral: Behavioral weight loss intervention
Weight loss intervention that focuses on reducing energy intake.
Experimental: 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.
Behavioral: 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: 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.
Behavioral: 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.

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). 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500356

Contacts
Contact: John M. Jakicic, PhD 412-488-4184 jjakicic@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: John M. Jakicic, PhD    412-488-4184    jjakicic@pitt.edu   
Principal Investigator: John M. Jakicic, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: John M. Jakicic, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01500356     History of Changes
Other Study ID Numbers: HL103646
Study First Received: December 22, 2011
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
cardiovascular disease
obesity
exercise

Additional relevant MeSH terms:
Cardiovascular Diseases
Obesity
Weight Loss
Body Weight
Body Weight Changes
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014