Better Adherence to Therapeutic Lifestyle Change Efforts Trial (BATTLE)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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