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Activity Counseling Trial (ACT)

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ClinicalTrials.gov Identifier: NCT00000551
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : March 25, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
To develop and evaluate the effectiveness of various intervention approaches, delivered in primary health-care settings, in increasing and maintaining habitual physical activity and cardiorespiratory fitness among sedentary men and women patients.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Heart Diseases Behavioral: health education Phase 3

Detailed Description:


A conference on physical activity sponsored by the National Heart, Lung, and Blood Institute (NHLBI) in August 1991 recommended that one priority area for research should be the development and evaluation of interventions for adoption and maintenance of physical activity including interventions that can be incorporated into primary care practice. The 1992 NHLBI Working Group Report on Primary Prevention of Hypertension identified physical inactivity as a risk factor for hypertension. Intervention research applicable to health-care settings is particularly important in light of national recommendations advising health-care professionals to intervene, including Healthy People 2000, the U.S. Preventive Services Task Force reports, and the American Heart Association.


Randomized, multicenter, demonstration and education study. Men and women primary care patients at three sites in Dallas, Palo Alto, and Memphis were randomized to two patient education intervention groups or to a standard care control group of physician advice. Intervention continued for two years for all participants. The primary outcomes were cardiorespiratory fitness and physical activity. Other outcomes were effects on blood pressure, lipoproteins, and weight; the long-term maintenance of these effects; and the cost-effectiveness of various intervention approaches. Recruitment took 15 months and has been completed with the accrual of 874 subjects.

The National Institute on Aging participated in the ACT through the addition of a measurement of arterial stiffness involving approximately 700 patients. The NIA tested the hypothesis that increases in physical activity resulting from educational interventions could reduce arterial stiffness.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Prevention
Study Start Date : September 1994
Estimated Study Completion Date : September 2002

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sedentary men and women, free of coronary heart disease, who were patients in primary care settings.

Information from the National Library of Medicine

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): NCT00000551

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
OverallOfficial: Timothy Morgan Bowman Gray School of Medicine


Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ACT
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.

ClinicalTrials.gov Identifier: NCT00000551     History of Changes
Other Study ID Numbers: 95
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: August 2007

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases