NCT00366990

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
349

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 8, 2016

Status Verified

March 1, 2016

Enrollment Period

2.9 years

First QC Date

August 18, 2006

Last Update Submit

March 5, 2016

Conditions

Cardiovascular DiseasesObesity

Keywords

Arterial Stiffening

Outcome Measures

Primary Outcomes (1)

  • Arterial stiffness

    Measured at Month 6

Secondary Outcomes (2)

  • Arterial stiffness and remodelling

    Measured at Months 6, 12 and 24

  • Endothelial function

    Measured at Months 6, 12, and 24

Study Arms (2)

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.

Behavioral: Low Sodium Diet

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.

Behavioral: Regular Sodium Intake

Interventions

Low Sodium DietBEHAVIORAL

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.

weight loss and sodium intake reduction
Regular Sodium IntakeBEHAVIORAL

Group sessions once a week for 16 weeks, bi-weekly for 16 weeks, and monthly for 16 weeks on behavioral \& weight loss topics.

weight loss and normal sodium intake

Eligibility Criteria

Age20 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) between 25 and 35

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (11)

  • 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.

    PMID: 22007645RESULT

  • 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.

    PMID: 23657296RESULT

  • 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.

    PMID: 23654212RESULT

  • 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.

    PMID: 22703865RESULT

  • 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.

    PMID: 20508622RESULT

  • 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.

    PMID: 26333626RESULT

  • 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.

    PMID: 22998737RESULT

  • 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.

    PMID: 25866258RESULT

  • 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.

    PMID: 24879662RESULT

  • 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.

    PMID: 23408709RESULT

  • 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.

    PMID: 28422536DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesObesity

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Emma Barinas-Mitchell, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 18, 2006

First Posted

August 22, 2006

Study Start

January 1, 2007

Primary Completion

December 1, 2009

Study Completion

June 1, 2013

Last Updated

March 8, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)