Better Adherence to Therapeutic Lifestyle Change Efforts Trial (BATTLE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT00458874
First received: April 9, 2007
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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 Intervention
Cardiovascular Disease
Behavioral: CIMT results

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 166
Study Start Date: November 2007
Study Completion Date: April 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

No publications provided

Responsible Party: Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT00458874     History of Changes
Other Study ID Numbers: WU#06-12025
Study First Received: April 9, 2007
Last Updated: December 16, 2013
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014