Low Sodium Diet and Behavioral Intervention for Reversing Arterial Stiffening in Overweight Individuals (SAVE)
|ClinicalTrials.gov Identifier: NCT00366990|
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : March 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Obesity||Behavioral: Low Sodium Diet Behavioral: Regular Sodium Intake||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||349 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial to Reverse Early Arterial Stiffening|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||June 2013|
Active Comparator: weight loss and sodium intake reduction
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.
Behavioral: Low Sodium Diet
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.
Placebo Comparator: weight loss and normal sodium intake
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.
Behavioral: Regular Sodium Intake
Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics.
- Arterial stiffness [ Time Frame: Measured at Month 6 ]
- Arterial stiffness and remodelling [ Time Frame: Measured at Months 6, 12 and 24 ]
- Endothelial function [ Time Frame: Measured at Months 6, 12, and 24 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00366990
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15260|
|Principal Investigator:||Emma Barinas-Mitchell, PhD||University of Pittsburgh|