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Better Adherence to Therapeutic Lifestyle Change Efforts Trial (BATTLE)

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ClinicalTrials.gov Identifier: NCT00458874
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
Henry M. Jackson Foundation for the Advancement of Military Medicine
Information provided by (Responsible Party):
Walter Reed National Military Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Behavioral: CIMT results Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Better Adherence to Therapeutic Lifestyle Change Efforts (BATTLE) Trial
Study Start Date : November 2007
Actual Primary Completion Date : July 2010
Actual Study Completion Date : April 2011
Arms and Interventions
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Arm Intervention/treatment
Experimental: Receive CIMT Results (R-CIMT)
This group will receive visual feedback of their CIMT results on a weekly basis.
 Behavioral: CIMT results
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.
No Intervention: Withhold CIMT Results (W-CIMT)
The W-CIMT group will not receive their CIMT results until the end of their study participation.


Outcome Measures
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Primary Outcome Measures :
  1. Change in lifestyle program adherence [ Time Frame: Baseline, Week 12 ]
    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.


Secondary Outcome Measures :
  1. CVD risk factors [ Time Frame: Baseline, 12 weeks ]
  2. C-reactive protein [ Time Frame: Baseline, Week 12 ]
  3. Anxiety [ Time Frame: Baseline, Week 2, Week 12 ]
  4. Atherosclerosis and CIMT Knowledge [ Time Frame: Week 12 ]
    Knowledge test will be given to R-CIMT group only.

  5. Adherence to each lifestyle change program component [ Time Frame: Baseline, Week 12 ]
    Adherence information will be collected on diet, exercise and attendance at weekly on-site sessions

  6. Motivation [ Time Frame: Baseline, Week 12 ]
  7. Self efficacy [ Time Frame: Baseline, Week 12 ]
    Nutrition and exercise self-efficacy


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Clinical CVD or conditions that limit safe participation
  • Individuals who participation would interfere with conduct of trial
  • No significant preclinical atherosclerosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00458874


Locations
United States, Maryland
Walter Reed National Military Medical Center / Integrative Cardiac Health Project (ICHP)
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Walter Reed National Military Medical Center
Henry M. Jackson Foundation for the Advancement of Military Medicine
Investigators
Principal Investigator: Randolph Modlin, MD Walter Reed Army Medical Center
Study Director: Marina N Vernalis, DO, FACC Henry M. Jackson Foundation for the Advancement of Military Medicine
More Information
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Publications of Results:
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.
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.
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.

Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT00458874     History of Changes
Other Study ID Numbers: WU#06-12025
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Walter Reed National Military Medical Center:
CV risk factors
subclinical atherosclerosis
lifestyle intervention
motivation

Additional relevant MeSH terms:
Cardiovascular Diseases