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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
  Purpose

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.


Condition Intervention
Cardiovascular Disease
 Behavioral: cardiovascular risk factor information

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:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Walter Reed Army Medical Center:

Primary Outcome Measures:
  • Adherence to therapeutic lifestyle change intervention [ Time Frame: Screening, Closeout ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 166
Study Start Date: November 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treatment group will receive a specific type of CV risk factor information.
 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.
No Intervention: B
This arm will have a specific CV risk factor information withheld.
 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458874

Locations
United States, District of Columbia
Walter Reed Army Medical Center / Integrative Cardiac Health Project
Washington, District of Columbia, United States, 20307
Sponsors and Collaborators
Walter Reed Army 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: COL Allen Taylor, MC, USA, Walter Reed Army Medical Center
ClinicalTrials.gov Identifier: NCT00458874     History of Changes
Other Study ID Numbers: WU#06-12025
Study First Received: April 9, 2007
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013