Activity Counseling Trial (ACT)

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000551
• Other study ID #: 95
• Status: Completed
• Phase: Phase 3
• First received: October 27, 1999
• Last updated: March 24, 2016
• Start date: September 1994
• Est. completion date: September 2002

Study information

• Verified date: August 2007
• Source: National Heart, Lung, and Blood Institute (NHLBI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

BACKGROUND:

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.

DESIGN NARRATIVE:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Sedentary men and women, free of coronary heart disease, who were patients in primary care settings.

Study Design

Allocation: Randomized, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases

Intervention

Behavioral:
• health education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (10)

Albright CL, Cohen S, Gibbons L, Miller S, Marcus B, Sallis J, Imai K, Jernick J, Simons-Morton DG. Incorporating physical activity advice into primary care: physician-delivered advice within the activity counseling trial. Am J Prev Med. 2000 Apr;18(3):225-34. — View Citation

Blair SN, Applegate WB, Dunn AL, Ettinger WH, Haskell WL, King AC, Morgan TM, Shih JA, Simons-Morton DG. Activity Counseling Trial (ACT): rationale, design, and methods. Activity Counseling Trial Research Group. Med Sci Sports Exerc. 1998 Jul;30(7):1097-106. — View Citation

Havlik RJ, Brock D, Lohman K, Haskell W, Snell P, O'Toole M, Ribisl P, Vaitkevicius P, Spurgeon HA, Lakatta EG, Pullen P. High-density lipoprotein cholesterol and vascular stiffness at baseline in the activity counseling trial. Am J Cardiol. 2001 Jan 1;87(1):104-7, A9. — View Citation

Havlik RJ, Phillips CL, Brock DB, Lohman K, Haskell W, Snell P, O'Toole M, Ribisl P, Vaitkevicius P, Spurgeon HA, Lakatta EG, Pullen P. Walking may be related to less vascular stiffness in the Activity Counseling Trial (ACT). Am Heart J. 2005 Aug;150(2):270-5. — View Citation

King AC, Sallis JF, Dunn AL, Simons-Morton DG, Albright CA, Cohen S, Rejeski WJ, Marcus BH, Coday MC. Overview of the Activity Counseling Trial (ACT) intervention for promoting physical activity in primary health care settings. Activity Counseling Trial Research Group. Med Sci Sports Exerc. 1998 Jul;30(7):1086-96. — View Citation

Margitic S, Sevick MA, Miller M, Albright C, Banton J, Callahan K, Garcia M, Gibbons L, Levine BJ, Anderson R, Ettinger W. Challenges faced in recruiting patients from primary care practices into a physical activity intervention trial. Activity Counseling Trial Research Group. Prev Med. 1999 Oct;29(4):277-86. — View Citation

Simons-Morton DG, Hogan P, Dunn AL, Pruitt L, King AC, Levine BD, Miller ST. Characteristics of inactive primary care patients: baseline data from the activity counseling trial. For the Activity Counseling Trial Research Group. Prev Med. 2000 Nov;31(5):513-21. — View Citation

Simons-Morton DG. The context of the Activity Counseling Trial. Med Sci Sports Exerc. 1998 Jul;30(7):1084-5. — View Citation

Wee CC. Physical activity counseling in primary care: the challenge of effecting behavioral change. JAMA. 2001 Aug 8;286(6):717-9. — View Citation

Writing Group for the Activity Counseling Trial Research Group. Effects of physical activity counseling in primary care: the Activity Counseling Trial: a randomized controlled trial. JAMA. 2001 Aug 8;286(6):677-87. — View Citation