Low Sodium Diet and Behavioral Intervention for Reversing Arterial Stiffening in Overweight Individuals
Condition: Cardiovascular Diseases; Obesity
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Low Sodium Diet; Regular Sodium Intake
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral & weight loss topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Arterial Stiffening