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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL066468-06 | U.S. NIH Grant/Contract | View source | |
| R01HL066468 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
The purpose of this study is to test the effect of lifestyle intervention on subclinical cardiovascular disease measures in women taking hormone replacement therapy (HRT).
BACKGROUND:
Cardiovascular disease is a common cause of morbidity and mortality in older women. Better methods of prevention via health promotion are needed. Estrogen HRT may beneficially affect women's cardiovascular health, based on evidence from observational studies, but recent trial evidence suggests HRT may actually lead to increased risk of cardiovascular disease in new users. Understanding this untoward effect of HRT and how to prevent it is a significant aim.
DESIGN NARRATIVE:
This randomized trial of 500 women on HRT for at least two years, aged 52-60 years, and three or more years postmenopausal will test whether reduction in waist circumference, triglycerides, dense low density lipoprotein cholesterol (LDLc), number of LDL particles, C-reactive protein, and plasminogen activator inhibitor-I (PAI-I) by aggressive diet and exercise, versus a health education control, and will decrease progression or result in regression of measures of subclinical vascular disease. The intervention is designed to reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. The primary endpoint will be a 20 percent or at least a 20 mg decrease in triglyceride levels, a 5 cm decrease in waist circumference, and a 10 percent decrease in LDLc. This will result in changes in subclinical measurements, including carotid ultrasound, electron beam computer tomography of the coronary artery and aorta, pulse wave velocity, endothelial function, and tonometry of the radial artery. Nuclear magnetic resonance spectroscopy of lipoproteins, inflammatory markers, and estrogen metabolites will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Participants will reduce total fat intake to 17 percent of calories, 1300 kilo calories, and increase moderate activity to 150-240 minutes per week to obtain a 10 percent reduction in weight. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet, fat-restricted | Behavioral | Reduction in total, saturated, trans fat, cholesterol, calories. Increase in fiber. Promotion of nutrient-dense, high-volume, low calorie foods. |
| Measure | Description | Time Frame |
|---|---|---|
| Measures of subclinical disease | 5 years | |
| Change in coronary calcium (EBCT) | 5 years | |
| Change in carotid intima media wall thickness | 5 years | |
| Change in vascular stiffness (PWV) | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference and weight | 5 years | |
| Change in LDL particles, triglycerides and small, medium and large LDL particles | 5 years | |
| Change in HDL particles |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis H. Kuller, MD, DPH | University of Pittsburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17087620 | Result | Kuller LH, Kinzel LS, Pettee KK, Kriska AM, Simkin-Silverman LR, Conroy MB, Averbach F, Pappert WS, Johnson BD. Lifestyle intervention and coronary heart disease risk factor changes over 18 months in postmenopausal women: the Women On the Move through Activity and Nutrition (WOMAN study) clinical trial. J Womens Health (Larchmt). 2006 Oct;15(8):962-74. doi: 10.1089/jwh.2006.15.962. | |
| 21494228 | Derived | Kuller LH, Pettee Gabriel KK, Kinzel LS, Underwood DA, Conroy MB, Chang Y, Mackey RH, Edmundowicz D, Tyrrell KS, Buhari AM, Kriska AM. The Women on the Move Through Activity and Nutrition (WOMAN) study: final 48-month results. Obesity (Silver Spring). 2012 Mar;20(3):636-43. doi: 10.1038/oby.2011.80. Epub 2011 Apr 14. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D018752 | Diet, Fat-Restricted |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Exercise | Behavioral | Rigorous, stepped care approach to reach 150 min/week of physical activity. |
|
| 5 years |
| Change in insulin and glucose | 5 years |
| Change in systolic blood pressure, diastolic blood pressure | 5 years |
| 20550691 | Derived | Gabriel KP, McClain JJ, Schmid KK, Storti KL, High RR, Underwood DA, Kuller LH, Kriska AM. Issues in accelerometer methodology: the role of epoch length on estimates of physical activity and relationships with health outcomes in overweight, post-menopausal women. Int J Behav Nutr Phys Act. 2010 Jun 15;7:53. doi: 10.1186/1479-5868-7-53. |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |