Better Adherence to Therapeutic Lifestyle Change Efforts Trial (BATTLE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00458874|
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : May 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Disease||Behavioral: CIMT results||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||166 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- CVD risk factors [ Time Frame: Baseline, 12 weeks ]
- C-reactive protein [ Time Frame: Baseline, Week 12 ]
- Anxiety [ Time Frame: Baseline, Week 2, Week 12 ]
- Atherosclerosis and CIMT Knowledge [ Time Frame: Week 12 ]Knowledge test will be given to R-CIMT group only.
- 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
- Motivation [ Time Frame: Baseline, Week 12 ]
- Self efficacy [ Time Frame: Baseline, Week 12 ]Nutrition and exercise self-efficacy
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
|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|