Better Adherence to Therapeutic Lifestyle Change Efforts Trial (BATTLE)

This study has been completed.

Sponsor:

Collaborator:

Henry M. Jackson Foundation for the Advancement of Military Medicine

Information provided by (Responsible Party):

Walter Reed National Military Medical Center

ClinicalTrials.gov Identifier:

NCT00458874

First received: April 9, 2007

Last updated: May 17, 2016

Last verified: May 2016

History of Changes

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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Better Adherence to Therapeutic Lifestyle Change Efforts (BATTLE) Trial

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 ]
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 ]
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


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.

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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Henry M. Jackson Foundation for the Advancement of Military Medicine

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

Publications:

Walizer EM, Vernalis MN, Modlin RE. Influence of CIMT as a motivator for health behavior change in a heart health program. Circulation 2014;129:AP126.

Walizer EM, Vernalis MN, Modlin RE. Adherence to a lifestyle intervention program not improved by visual knowledge of carotid intima atherosclerosis. Circ Cardiovasc Qual Outcomes 2013;6:A43.

Walizer E, Kashani M, Eliasson A, Vernalis M. Integrative Cardiac Health Project risk score improves cardiovascular risk assessment in women with subclinical atherosclerosis. J Cardiovasc Nurs 2011; 26(4):265A.


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:	May 17, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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 September 19, 2017

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