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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL077525 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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Obese individuals are at risk for developing cardiovascular disease (CVD). Increasing physical activity, losing weight, and reducing sodium intake may reverse arterial stiffness and blood vessel damage that is linked to obesity. This study will evaluate the effectiveness of a low sodium diet and a behavioral weight loss intervention in reducing arterial stiffness in overweight young adults.
CVD includes diseases that affect the heart and blood vessels. Arterial stiffness, in which arteries harden and become less flexible, increases the risk of developing CVD. Arterial stiffness increases both with age and in certain disease states, including high blood pressure, diabetes, and obesity. Young adults who are obese prematurely place themselves at risk for developing arterial stiffness and CVD. Physical activity and weight loss may reverse arterial stiffness in these individuals. Reducing sodium intake, which has been proven to decrease blood pressure, may also improve blood vessel function and arterial stiffness. The purpose of this study is to evaluate the effectiveness of a low sodium diet and a behavioral weight loss intervention in reducing arterial stiffness in young, moderately overweight individuals.
Participants will first attend a baseline study visit, at which time blood will be collected, and height, weight, waist circumference, and blood pressure will be measured. Questionnaires to assess medical history, physical activity levels, and dietary habits will be completed. An ultrasound will be used to evaluate blood vessel function and arterial stiffness. All participants will then take part in a 12-month behavioral and dietary intervention. The intervention will emphasize increasing physical activity and decreasing caloric intake by modifying lifestyle choices, physical and social environments, and attitudes toward food and exercise. Participants will be randomly assigned to follow either a low sodium diet or a normal sodium diet. During Months 1 through 4, participants will attend weekly study visits for group counseling sessions; during Months 4 through 8, study visits will occur once every two weeks; and during Months 8 through 12, they will occur once a month. At each study visit, weight, waist circumference, and blood pressure will also be measured. If necessary, individual counseling sessions will be scheduled. Participants will also document daily physical activity and caloric intake in a diary. Baseline evaluations will be repeated at Months 6, 12, and 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| weight loss and sodium intake reduction | Active Comparator | Behavioral and weight loss intervention, including a low sodium diet. Study goals are a 10% weight loss, 200 minutes of moderate physical activity a week, such as walking, and a 50% reduction in sodium intake. |
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| weight loss and normal sodium intake | Placebo Comparator | Behavioral and weight loss intervention, with regular sodium intake. Study goals are a 10% weight loss, 200 minutes of moderate physical activity a week, such as walking. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Sodium Diet | Behavioral | Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics with a focus on lowering sodium intake. |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness | Measured at Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Arterial stiffness and remodelling | Measured at Months 6, 12 and 24 | |
| Endothelial function | Measured at Months 6, 12, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emma Barinas-Mitchell, 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 |
|---|---|---|---|
| 22007645 | Result | Cooper JN, Tepper P, Barinas-Mitchell E, Woodard GA, Sutton-Tyrrell K. Serum aldosterone is associated with inflammation and aortic stiffness in normotensive overweight and obese young adults. Clin Exp Hypertens. 2012;34(1):63-70. doi: 10.3109/10641963.2011.618200. Epub 2011 Oct 18. | |
| 23657296 | Result | Cooper JN, Fried L, Tepper P, Barinas-Mitchell E, Conroy MB, Evans RW, Mori Brooks M, Woodard GA, Sutton-Tyrrell K. Changes in serum aldosterone are associated with changes in obesity-related factors in normotensive overweight and obese young adults. Hypertens Res. 2013 Oct;36(10):895-901. doi: 10.1038/hr.2013.45. Epub 2013 May 9. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D004039 | Diet, Sodium-Restricted |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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| Regular Sodium Intake | Behavioral | Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics. |
|
| 23654212 | Result | Cooper JN, Evans RW, Mori Brooks M, Fried L, Holmes C, Barinas-Mitchell E, Sutton-Tyrrell K. Associations between arterial stiffness and platelet activation in normotensive overweight and obese young adults. Clin Exp Hypertens. 2014;36(3):115-22. doi: 10.3109/10641963.2013.789045. Epub 2013 May 8. |
| 22703865 | Result | Cooper JN, Buchanich JM, Youk A, Brooks MM, Barinas-Mitchell E, Conroy MB, Sutton-Tyrrell K. Reductions in arterial stiffness with weight loss in overweight and obese young adults: potential mechanisms. Atherosclerosis. 2012 Aug;223(2):485-90. doi: 10.1016/j.atherosclerosis.2012.05.022. Epub 2012 May 30. |
| 20508622 | Result | Njoroge JN, El Khoudary SR, Fried LF, Barinas-Mitchell E, Sutton-Tyrrell K. High urinary sodium is associated with increased carotid intima-media thickness in normotensive overweight and obese adults. Am J Hypertens. 2011 Jan;24(1):70-6. doi: 10.1038/ajh.2010.113. Epub 2010 May 27. |
| 26333626 | Result | Lee JJ, Woodard GA, Gianaros PJ, Barinas-Mitchell E, Tepper PG, Conroy MB. Ectopic adiposity is associated with autonomic risk factors and subclinical cardiovascular disease in young adults. Obesity (Silver Spring). 2015 Oct;23(10):2030-6. doi: 10.1002/oby.21138. Epub 2015 Sep 3. |
| 22998737 | Result | Hughes TM, Althouse AD, Niemczyk NA, Hawkins MS, Kuipers AL, Sutton-Tyrrell K. Effects of weight loss and insulin reduction on arterial stiffness in the SAVE trial. Cardiovasc Diabetol. 2012 Sep 22;11:114. doi: 10.1186/1475-2840-11-114. |
| 25866258 | Result | Niemczyk NA, Catov JM, Barinas-Mitchell E, McClure CK, Roberts JM, Tepper PG, Sutton-Tyrrell K. Nulliparity is associated with less healthy markers of subclinical cardiovascular disease in young women with overweight and obesity. Obesity (Silver Spring). 2015 May;23(5):1085-91. doi: 10.1002/oby.21044. Epub 2015 Apr 10. |
| 24879662 | Result | Hawkins M, Gabriel KP, Cooper J, Storti KL, Sutton-Tyrrell K, Kriska A. The impact of change in physical activity on change in arterial stiffness in overweight or obese sedentary young adults. Vasc Med. 2014 Aug;19(4):257-263. doi: 10.1177/1358863X14536630. Epub 2014 May 30. |
| 23408709 | Result | Smith HA, Storti KL, Arena VC, Kriska AM, Gabriel KK, Sutton-Tyrrell K, Hames KC, Conroy MB. Associations between accelerometer-derived physical activity and regional adiposity in young men and women. Obesity (Silver Spring). 2013 Jun;21(6):1299-305. doi: 10.1002/oby.20308. |
| 28422536 | Derived | Lott MP, Kriska A, Barinas-Mitchell E, Wang L, Storti K, Winger DG, Conroy MB. Impact of Lifestyle Strategies on Longer-Term Physical Activity and Weight. J Phys Act Health. 2017 Aug;14(8):606-611. doi: 10.1123/jpah.2016-0508. Epub 2017 Apr 19. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |