NCT00458874

Brief Summary

The purpose of this study is to determine whether knowledge of abnormal results from a noninvasive test for detection of subclinical atherosclerosis (carotid intima media thickness \[CIMT\]), in addition to knowledge of cardiovascular disease (CVD) risk factors, enhances adherence to healthy lifestyle behaviors in comparison to only CVD risk factor knowledge. We believe that participants with CVD risk factors who have knowledge of their own CIMT test results showing significant subclinical atherosclerosis will demonstrate better adherence to therapeutic lifestyle change (TLC) than those subjects from whom the CIMT test information is withheld.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
166

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Longer than P75 for not_applicable

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

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

2.7 years

First QC Date

April 9, 2007

Last Update Submit

May 17, 2016

Conditions

Cardiovascular Disease

Keywords

CV risk factorssubclinical atherosclerosislifestyle interventionmotivation

Outcome Measures

Primary Outcomes (1)

  • Change in lifestyle program adherence

    A composite index of adherence to the TLC intervention was selected as the primary outcome measure since the main goal of this study is to assess the impact of CIMT imaging knowledge on change in lifestyle behaviors.

    Baseline, Week 12

Secondary Outcomes (7)

  • CVD risk factors

    Baseline, 12 weeks

  • C-reactive protein

    Baseline, Week 12

  • Anxiety

    Baseline, Week 2, Week 12

  • Atherosclerosis and CIMT Knowledge

    Week 12

  • Adherence to each lifestyle change program component

    Baseline, Week 12

  • +2 more secondary outcomes

Study Arms (2)

Receive CIMT Results (R-CIMT)

EXPERIMENTAL

This group will receive visual feedback of their CIMT results on a weekly basis.

Behavioral: CIMT results

Withhold CIMT Results (W-CIMT)

NO INTERVENTION

The W-CIMT group will not receive their CIMT results until the end of their study participation.

Interventions

CIMT resultsBEHAVIORAL

Both groups will receive a weekly confidential packet of scripted materials (e.g. educational materials, class schedules, feedback from diet/exercise logs). The R-CIMT group will also receive an CIMT report which contains a copy of one of their own ultrasound scans, with a comparison "normal" scan. This report will also include the CIMT thickness, an interpretation that states their measurements are in the highest quartile for persons of their age and gender, and associated CVD risk. "Interpreting Your CIMT Results" tutorial will be included in the first weekly packet to educate subjects on the detection of atherosclerosis with carotid ultrasound. The CIMT results are withheld from the W-CIMT group until the end of their study participation along with the CIMT tutorial.

Receive CIMT Results (R-CIMT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Military healthcare beneficiary
  • Willing to modify current diet and exercise habits
  • Two or more of following CVD risk factors (hypertension, hyperlipidemia, family history, tobacco use, BMI \>/= 25 kg/m2)
  • Metabolic syndrome

You may not qualify if:

  • Clinical CVD or conditions that limit safe participation
  • Individuals who participation would interfere with conduct of trial
  • No significant preclinical atherosclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed National Military Medical Center / Integrative Cardiac Health Project (ICHP)

Bethesda, Maryland, 20889, United States

Location

Related Publications (3)

  • Walizer EM, Vernalis MN, Modlin RE. Influence of CIMT as a motivator for health behavior change in a heart health program. Circulation 2014;129:AP126.

    RESULT

  • Walizer EM, Vernalis MN, Modlin RE. Adherence to a lifestyle intervention program not improved by visual knowledge of carotid intima atherosclerosis. Circ Cardiovasc Qual Outcomes 2013;6:A43.

    RESULT

  • Walizer E, Kashani M, Eliasson A, Vernalis M. Integrative Cardiac Health Project risk score improves cardiovascular risk assessment in women with subclinical atherosclerosis. J Cardiovasc Nurs 2011; 26(4):265A.

    RESULT

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Randolph Modlin, MD

    Walter Reed Army Medical Center

    PRINCIPAL INVESTIGATOR

  • Marina N Vernalis, DO, FACC

    Henry M. Jackson Foundation for the Advancement of Military Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

November 1, 2007

Primary Completion

July 1, 2010

Study Completion

April 1, 2011

Last Updated

May 18, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)