Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00366990
Status:
COMPLETED
Last Update Posted:
2016-03-08
First Post:
2006-08-18
Brief Title:
Low Sodium Diet and Behavioral Intervention for Reversing Arterial Stiffening in Overweight Individuals
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Clinical Trial to Reverse Early Arterial Stiffening
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVE
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5R01HL077525 | NIH | None | httpsreporternihgovquickSearch5R01HL077525 |