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Low Sodium Diet and Behavioral Intervention for Reversing Arterial Stiffening in Overweight Individuals (SAVE)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Emma Barinas-Mitchell, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00366990
First received: August 18, 2006
Last updated: March 5, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Cardiovascular Diseases
Obesity
Behavioral: Low Sodium Diet
Behavioral: Regular Sodium Intake

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Clinical Trial to Reverse Early Arterial Stiffening

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Arterial stiffness [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arterial stiffness and remodelling [ Time Frame: Measured at Months 6, 12 and 24 ] [ Designated as safety issue: No ]
  • Endothelial function [ Time Frame: Measured at Months 6, 12, and 24 ] [ Designated as safety issue: No ]

Enrollment: 349
Study Start Date: January 2007
Study Completion Date: June 2013
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 25 and 35

Exclusion Criteria:

  • High blood pressure currently being treated with medication
  • Blood pressure greater than or equal to 140/90 mm Hg on two consecutive study visits
  • Diabetes, defined as either a fasting glucose test result of .126 or current use of hypoglycemic medications
  • Currently taking hyperlipidemia medication
  • Currently taking vasoactive medications
  • History of known atherosclerotic disease (e.g., angina, heart attack, lower extremity arterial disease)
  • Underlying inflammatory condition (e.g., systemic lupus erythematosus, rheumatoid arthritis)
  • Chronic infection
  • Current participation in a formal exercise or weight loss program
  • Pregnant or planning to become pregnant during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00366990

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Emma Barinas-Mitchell, PhD University of Pittsburgh
  More Information

Publications:

Responsible Party: Emma Barinas-Mitchell, PhD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00366990     History of Changes
Other Study ID Numbers: 415  5R01HL077525 
Study First Received: August 18, 2006
Last Updated: March 5, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Pittsburgh:
Arterial Stiffening

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2016