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Better Adherence to Therapeutic Lifestyle Change Efforts Trial (BATTLE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by Walter Reed Army Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Walter Reed Army Medical Center
ClinicalTrials.gov Identifier:
NCT00458874
First received: April 9, 2007
Last updated: March 23, 2010
Last verified: July 2008
History of Changes

April 9, 2007
March 23, 2010
November 2007
July 2010   (final data collection date for primary outcome measure)
Adherence to therapeutic lifestyle change intervention [ Time Frame: Screening, Closeout ] [ Designated as safety issue: No ]
Adherence to therapeutic lifestyle change intervention
Complete list of historical versions of study NCT00458874 on ClinicalTrials.gov Archive Site
  • CVD risk factors [ Time Frame: Screening, Closeout ] [ Designated as safety issue: No ]
  • C-reactive protein [ Time Frame: Screening, Closeout ] [ Designated as safety issue: No ]
  • Anxiety [ Time Frame: Screening, Main Study, Close-out ] [ Designated as safety issue: No ]
  • Stage of Change [ Time Frame: Randomization visit, Closeout ] [ Designated as safety issue: No ]
  • CVD risk factors
  • C-reactive protein
  • Anxiety
  • Stage of Change
Not Provided
Not Provided
 
Better Adherence to Therapeutic Lifestyle Change Efforts Trial
Better Adherence to Therapeutic Lifestyle Change Efforts (BATTLE) Trial

The purpose of the research study is to determine whether different types of cardiovascular risk factor information influence the practice of healthy lifestyle behaviors, such as diet and exercise.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cardiovascular Disease
Behavioral: cardiovascular risk factor information
Mediterranean diet; Aerobic exercise >/= 180 min/wk. Both arms will follow the lifestyle change program. Experimental group will receive specific risk factor information that the control arm will not receive.
  • Experimental: A
    Treatment group will receive a specific type of CV risk factor information.
    Intervention: Behavioral: cardiovascular risk factor information
  • No Intervention: B
    This arm will have a specific CV risk factor information withheld.
    Intervention: Behavioral: cardiovascular risk factor information
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
166
December 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00458874
WU#06-12025
No
COL Allen Taylor, MC, USA, Walter Reed Army Medical Center
Walter Reed Army Medical Center
Not Provided
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
Walter Reed Army Medical Center
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP