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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet alone | Experimental | Weight loss intervention that focuses only on reducing energy intake of the diet. |
|
| Diet plus Moderate Exercise | 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 High 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral weight loss intervention | Behavioral | Weight loss intervention that focuses on reducing energy intake. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Left ventricular mass assessed using cardiac MRI | Left ventricular mass will be assessed using cardiac MRI | Baseline (0 months) and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in end-diastolic volume assessed using cardiac MRI | Assessed using cardiac MRI | baseline (0 months) and 12 months |
| Change in cardiorespiratory fitness | Measured using a graded exercise test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John M. Jakicic, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35470972 | Derived | Jakicic JM, Rogers RJ, Lang W, Gibbs BB, Yuan N, Fridman Y, Schelbert EB. Impact of weight loss with diet or diet plus physical activity on cardiac magnetic resonance imaging and cardiovascular disease risk factors: Heart Health Study randomized trial. Obesity (Silver Spring). 2022 May;30(5):1039-1056. doi: 10.1002/oby.23412. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004032 | Diet |
| ID | Term |
|---|---|
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Diet Plus Moderate Exercise | Behavioral | 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 High Exercise | Behavioral | 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. |
|
| baseline (0 months) 6 months, and 12 months |
| Change in blood levels of C-Reactive Protein (CRP) | Assessed from a fasting blood sample | baseline (0 months), 6 months, and 12 months |
| Change in body weight | baseline (0 months), 6 months, and 12 months |
| Change in body composition | Measured using dual-energy x-ray absorptiometry (DXA) | baseline (0 months), 6 months, and 12 months |
| Change in regional adiposity | Measured using anthromometry that includes girth measures of the waist and hip | baseline (0 months), 6 months, 12 months |
| Change in physical activity | Measured using both a wearable device and by questionnaire | baseline (0 months), 6 months, 12 months |
| Change in energy intake | Assessed using a questionnaire | baseline (0 months), 6 months, 12 months |
| Change in traditional CVD risk factors (lipids, glucose, insulin) | Measured from a fasting blood sample | baseline (0 months), 6 months, 12 months |
| Change in resting blood pressure | baseline (0 months), 6 months, 12 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |