Better Adherence to Therapeutic Lifestyle Change Efforts Trial (BATTLE)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Better Adherence to Therapeutic Lifestyle Change Efforts (BATTLE) Trial|
- Change in lifestyle program adherence [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]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.
- CVD risk factors [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
- C-reactive protein [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
- Anxiety [ Time Frame: Baseline, Week 2, Week 12 ] [ Designated as safety issue: No ]
- Atherosclerosis and CIMT Knowledge [ Time Frame: Week 12 ] [ Designated as safety issue: No ]Knowledge test will be given to R-CIMT group only.
- Adherence to each lifestyle change program component [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]Adherence information will be collected on diet, exercise and attendance at weekly on-site sessions
- Motivation [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
- Self efficacy [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]Nutrition and exercise self-efficacy
|Study Start Date:||November 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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.
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|United States, Maryland|
|Walter Reed National Military Medical Center / Integrative Cardiac Health Project (ICHP)|
|Bethesda, Maryland, United States, 20889|
|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|